Draft Guidance Document - Satiety Health Claims on Food
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Table of Contents
- 1.0 Introduction
- 2.0 Context
- 3.0 Type of Health Claim for Satiety
- 4.0 State of Science on Satiety
- 5.0 Guiding Principles for the Substantiation of Satiety Health Claims
- 6.0 Claim Wording
- 7.0 Summary
List of Tables
The purpose of this Guidance Document is to define the acceptable use of satiety health claims in the labelling and advertising of food products sold in Canada. It also provides guidance to industry for complying with subsection 5(1) of the Food and Drugs Act by making substantiated satiety health claims that are truthful and not misleading. This Guidance Document is a complement to Health Canada's Guidance Documents for Preparing a Submission for Food Health Claims.
This Guidance Document applies to products that are manufactured, sold, or represented for use as food, as is defined in Section 2 of the Food and Drugs Act, and for which a satiety claim is being made. To fully understand the regulations governing the sale and advertising of foods, the document should be read together with applicable provisions of the Food and Drugs Act and its regulations and all other legislation and regulations applicable to foods, as well as their associated policies and guidelines. Food manufacturers are responsible for compliance with all relevant food legislation and regulations and for the accuracy of all the information on the labels and in the advertisements of their products.
The following descriptions are provided as working definitions for the purpose of this document.
Appetite is the combination of sensations that lead to seeking, choosing, and ingesting food (Blundell et al. 2010).
Comparative claims are claims where the food that is the subject of the claim is compared to a reference (control) food.
Food refers to a food (whole or processed) or a beverage that is the subject of the claim and that is tested as consumed.
Fullness is a physical feeling that could be related to the degree of stomach filling (Salmenkallio-Marttila 2009).
Hunger refers to the physiological recognition of a need to eat (adapted from Blundell 2010).
Function claims are health claims that describe specific beneficial physiological effects of foods or food constituents on normal functions or biological activities of the body associated with health or performance.
Preload is the food (test, reference, or control) given to participants prior to measuring its effect on subjective appetite ratings and/or energy intake at a subsequent meal.
Reference food is the food used for comparison to a test product. When the reference food differs from the test food by only one variable, it is referred to as the control food.
Satiation refers to the processes that lead to the reduction or termination of eating within a meal and determines meal size (Blundell et al. 2010).
Satiety refers to the processes that inhibit further intake after an eating occasion has ended; (Livingstone, 2010).
Test meal is the meal given to study participants within a pre-determined time after the preload that aims at assessing the effect of the preload on the amount of food consumed at that meal.
Visual Analogue Scales (VAS) are a type of methodological tools that measure subjective ratings of appetite.
There is a growing interest in health effects of foods among consumers and the food industry. In 2009, Health Canada's Food Directorate developed an action plan for the modernization of the framework of health claims on food aimed at increasing industry's capacity to make function claims on foods while retaining high standards to maintain credibility of these claims.
In this context and as a complement to Health Canada's Guidance Documents for Preparing a Submission for Food Health Claims, this document sets out the criteria by which the validity of satiety claims may be assessed. It will therefore assist in industry's use of satiety claims compliant with subsection 5(1) of the Food and Drugs Act.
3.0 Type of Health Claim for Satiety
In Canada, food-related health claims have been classed into three main categories: disease risk reduction claims and therapeutic claims; function claims; and general health claims. Satiety claims would be considered function claims based on the modulating effects of foods on sensations of appetite, such as increased feeling of fullness and/or reduced sense of hunger. These effects could potentially be beneficial to individuals who wish to control their energy intake. Based on the premise that all foods potentially modulate appetite-related sensations, satiety claims must, in general, be comparative claims, whereby the food bearing the claim shows beneficial effects on measures of satiety when compared to a reference (control) food. Exceptions might apply if an adequate reference food is unavailable for such a comparison to be made (see sections 5.1.2, 5.5.4).
While the use of function claims on food does not trigger premarket review by Health Canada, the manufacturer or distributor of the food product carrying such a claim remains responsible for documenting the validity of the claim. As with all claims about the health effects of foods, function claims must be substantiated by scientific evidence obtained through well-designed human studies in accordance with the guidance documents for supporting food health claims mentioned in section 2. Satiety claims must not directly or indirectly refer to body weight because satiety is only one factor among many influencing body weight, as well as because satiety studies are usually acute and of too short duration to provide sufficient evidence of an effect on body weight.
4.0 State of Science on Satiety
4.1 Methods for Measuring Satiation, Satiety and Energy Intake
Satiation and satiety are processes that affect eating behaviour and are assessed by a combination of objective (energy intake) and subjective (ratings of appetite-related sensations) measures.
4.1.1 Satiation is measured experimentally through the study participant's ad libitum consumption of the food under investigation during an eating occasion. The measurement is typically conducted under controlled conditions to minimize the impact of environment-related and cognitive confounding factors as well as organoleptic properties of the food on the termination of an eating occasion and thus the amount of a particular food that is eaten.
4.1.2 Satiety is measured by the magnitude or duration of changes in subjective ratings of appetite-related sensations with or without measurement of energy intake at a subsequent meal. Appetite sensations are a reliable and a valid method for measuring subjective states of motivation to eat before and in response to meals (Flint 2000). The method commonly used is a self-report scale, such as Visual Analogue Scales (VAS). It consists of questions that assess subjective appetite-related sensations (see Table 1) in a controlled setting in response to an eating occasion right before and after consuming a preload or a test meal, and then at regular time intervals. Variations of the VAS exist, but the standard is a 100-150 mm horizontal line, anchored at each end with opposing extremes of a specific scale (for example, "not at all hungry" to "extremely hungry"). The study participants are instructed to make a mark on the line that corresponds to their feelings. The subjective sensation is quantified by measuring the distance from the left end of the line to the mark. When used in this context, VAS has an acceptable degree of validity and reliability. They are non-invasive to participants and easy to use and found to be sensitive to experimental manipulation, reproducible in repeated protocols where the effect of different treatments are compared under similar circumstances and exhibit a good degree of within subject reliability (Stubbs 2000, Flint 2000, Livingstone 2000, Arvaniti 2000). The scales described in Table 1 are the most commonly used and accepted in various countries and laboratories (Blundell 2010). Other scales such as category (fixed points) and satiety-labelled intensity magnitudes (SLIM) have been used for reporting subjective feelings of hunger, fullness or satiety. However, these scales are not universally accepted and still require further development (Benelam 2009).
4.1.3 Energy (caloric) intake in studies assessing satiation/satiety effects is measured through accurate monitoring of the food consumed ad libitum. In the case of satiation, the intake of the test food by itself or as part of a meal is measured, whereas in the case of satiety, energy intake at a test meal is measured within a pre-determined time after the preload. The test meal has typically been either a buffet style meal or a single meal pre-selected by the participant from a list of foods offered by the experimenter. However, it is advisable to avoid buffet style meals as energy intake may be more indicative of food choice rather than satiety-related effects of the preload.
|Hunger||How hungry are you?||Not at all hungry||Extremely hungry|
|Fullness||How full are you?||Not at all full||Extremely full|
|Desire to eat||How strong is your desire to eat?||Not at all strong||Extremely strong|
|Prospective Food Consumption (PFC)||How much do you think you could eat?||None at all||A large amount|
4.1.4 Other measures of satiety include satiety index (SI) and satiety quotient (SQ). Satiety index (Holt 1995) is a measure of the potency of a food to satisfy hunger relative to white bread (index of 100). Foods scoring higher than 100 are more satisfying than white bread and those under 100 are less satisfying. Satiety quotient considers the satiating effects of an eating episode over time (Green 1997). However data about the relationship between energy intake and rated subjective sensations of appetite is conflicting. Evidence of the usefulness of both SI and SQ for quantifying satiety and their reproducibility are considered insufficient to be used for health claim substantiation. Health Canada encourages further research in this area.
4.2 Physiological Biomarkers of Satiation and Satiety
Interest in the use of biomarkers to measure satiety is based on their potential to indicate putative mechanisms of action and their presumed lower susceptibility to subjectivity and modification by environmental factors. Several gastrointestinal hormones released during or after eating (such as cholecystokinin (CCK), glucagon-like peptide 1 (GLP-1), bombesin, peptide-tyrosine (PYY), ghrelin, enterostatin, glucose-dependent insulino-tropic polypeptide (GIP), pancreatic polypeptide, and somatostatin) as well as gastric emptying and intestinal transit times could influence satiety and food consumption (Salmenkalio-Marttilla 2008). While these outcome measures can provide supplementary information, they are insufficient by themselves in supporting a satiety claim at present.
4.3 Limitations of Satiety Studies and Their Impact on Satiety Claims
Although research in this area has been very active in the last few decades, it is recognized that satiety studies face a number of challenges at the present time.
4.3.1 Satiety studies are normally conducted in tightly controlled test settings to achieve the highest degree of sensitivity and control over intervening variables, such as environmental cues, and cognitive and socio-cultural factors. As such, controlled laboratory testing provides proof of potential, but the effect is not necessarily detectable in free-living conditions where intervening variables exert a strong influence on appetite-related sensations and eating behaviour. Moreover, the effect of a food on satiety measures and energy intake derived from a single eating occasion is not necessarily sustainable, as repeated consumption could either lead to habituation and waning of the effect over time or to strengthening of the effect due to learning. Consequently, studies used to substantiate satiety health claims should not only demonstrate effects of foods using robust statistical treatment of the data (section 5.6), but evidence should also be given showing that these effects are maintained following a regular consumption of the food for a period of time (see section 5.2.1).
4.3.2 While VAS have an acceptable degree of reproducibility when used with single eating occasions (Stubbs 2000, Flint 2000Livingstone 2000), they do not consistently correlate with energy intake at the subsequent meal (Blundell et al. 2009). Hence, an effect on appetite-related sensations does not necessarily translate into a reduction in the amount of energy consumed at the subsequent meal. However, favourable changes in appetite-related sensations could help prevent overeating in people who wish to control their energy intake.
Given the preceding considerations, Health Canada determines that the scope of possible satiety claims on food will be limited at this time, but encourages further research in areas that will strengthen the evidence to support satiety claims.
4.3.3 While a single food might lead to reductions in energy intake within a meal or at a subsequent meal, compensations usually occur at later meals such that total daily energy intake is usually unaffected. Therefore, the methodology described in this document will only allow substantiation of claims related to subjective appetite-related sensations, but will not allow supporting energy intake claims, including satiation claims.
4.3.4 While VAS have been shown by some researchers to be reliable for use by children aged 9-13 years (Bellissimo 2008), others have suggested that young children, generally 7 years of age or younger, may not have the conceptual and cognitive ability to use VAS (Shields 2003). Therefore, satiety claims should not be made on child-directed products at this time
4.3.5 Changes in the physiological biomarkers, such as gastrointestinal hormones, involved in satiety do not always correlate with satiety measures or food intake measures (Mattes 2008). Thus, while physiological biomarkers can be used as supportive evidence, they cannot form the basis of a claim at present, nor should a claim be worded to include a reference to a biomarker.
5.0 Guiding Principles for the Substantiation of Satiety Health Claims
The following are guiding principles for studies on satiety and are not meant to define precise protocols.
5.1 General Considerations
5.1.1 Given that any energy-providing food affects satiation and satiety to a certain degree, satiety health claims should in general be comparative, i.e. comparison of the test food with an appropriate reference (control) food. Examples include: A serving of product X with n grams of ingredient Y is more filling for 2 hours than product X without ingredient Y", or "A serving of product X increases feelings of fullness longer than a serving of product Y".
5.1.2 Only in instances where an appropriate reference food is unavailable, such as when there is a too large difference between the composition of the test food and possible reference foods, could a non-comparative satiety-related claim be made. These types of claims would refer to the duration, rather than the magnitude of the effect on satiety-related sensations (see section 5.5.4 and Table 2).
5.1.3 Available evidence does not support satiety claims based on generic macronutrient content (e.g. protein or fibre) of individual foods. For example, the observed effects of protein when given as the predominant or sole source of energy in the preloads cannot be extrapolated to protein content of foods in general, as the effect of macronutrients on satiety also depends on their source and type, as well as the food form.
5.2 Study Design and Study Conduct Considerations
5.2.1 To support a satiety health claim, the studies must be of sufficient quality and duration to be conclusive. The quality of each study is assessed against applicable standards such as clearly defined objectives, participant selection, methods and procedures, and statistical analyses. Thus, preliminary or pilot studies are insufficient as supporting evidence. There is no pre-established formula as to how many or what type of studies are needed to substantiate a satiety health claim. In this regard, the sustainability and reproducibility of the reported effect should be demonstrated in longer studies where the test food is fed frequently (the appropriate length of the study period should be justified by the researchers). The frequency of consumption of the food should realistically reflect its consumption pattern; for example, a snack food could be consumed daily, whereas an entrée may be consumed less frequently during the test period. It is recommended that the effect of the food be tested at least twice, before and at the end of the study period. Furthermore, consistency between studies conducted by at least two independent research groups is an important consideration, unless a claim is made about an ingredient in a food for which supportive evidence already exists in other food forms.
5.2.2 Most satiety studies supporting a claim should include at least three experimental treatments as preloads: the test food, the control food (for comparative claim) or the reference food (for non-comparative claim), and the energy-free control (see sections 5.3.3 and 5.3.4).
5.2.3 Each subject should get all preload and test meal treatments at the beginning and at the end of the study period where the test and reference/control foods are consumed frequently. It is recommended to allow for a reasonable wash out time between the different treatments. The duration of the study period must be defined and justified in the study protocol.
5.2.4 Satiety studies should assess subjective ratings by the administration of the different scales of the VAS before and at selected time intervals after the administration of the preloads. The satiety claim depends on the anticipated effect of the food being tested and the specific scale showing a significantly improved effect (for example, fullness, hunger) (see section 5.5 for details).
5.2.5 The duration and intervals of the VAS measurements should be based on prior knowledge of the effects of the food or ingredient or established from preliminary tests and should be consistent with the type and consumption pattern of the food being tested; for example, if the test food is normally consumed as part of a main meal (lunch or dinner), its effect on satiety measures should be more prolonged than if the test food is normally consumed as a snack. The number of VAS measurements and intervals can vary from one study to another; however, the first measurement should be prior to administration of the preload, and the last one should be prior to the administration of the subsequent test meal.
5.2.6 The time of the day at which the test food is offered and the appropriateness of the food for that time of the day need to be considered.
5.2.7 Evidence for adequate statistical power and analyses should be provided when selecting a study design. Cross-over (within-subject) study designs are preferred, but parallel designs are acceptable if justified.
5.2.8 The setting of the study should be reported and the description of the experimental design should include identification of the randomization procedures.
5.2.9 Double-blinding (where study participants, those involved with their management, and/or those collecting and analyzing data are kept unaware of the assigned treatment) is the preferred method to avoid bias, but if not performed, an explanation of why it was not possible or appropriate for the study should be provided. When assessing the time to the next meal, study participants should also be time-blinded so that they are not influenced by pre-conceived notions of when the next meal should occur and by the associated subjective sensations of satiety.
5.2.10 It is recommended that antecedent levels of energy depletion and physical activity experienced by the study subjects be standardized prior to testing to allow proper interpretation of results.
5.2.11 Researchers may find it helpful to review and use the guidelines provided by the CONSORT (Consolidated Standards of Reporting Trials) Statement in documenting their studies. The CONSORT statement is intended to improve the reporting of randomized controlled studies, enabling readers to understand a study's design, conduct, analysis and interpretation, and to assess the validity of study results.
5.3 Characterization of the Test and Reference Foods
The following information is required to fully characterize the test and reference foods as well as the energy-free control:
5.3.1 The food being tested and the reference food should be identified and described in terms of constituents (macro- and micronutrients), physical form (solid, semi-solid, or liquid), and amounts. The amount of the food tested and the reference food should match the serving size as stated in the Nutrition Facts table. Preliminary tests should be conducted to demonstrate that palatability was not altered by the manipulation of the food and that the test and the reference foods are similarly liked by the study participants.
5.3.2 If the effect of the food tested is attributed to a specific added component, then this component should be identified.
5.3.3 The choice and appropriateness of the reference foods should be justified. The choice of the reference food depends on the product being tested and outcome(s) of interest; for example, when the effect of a product on a satiety measure is attributed to the addition of a specific ingredient, such as a viscous fibre, an appropriate reference food would be a control food with a non-viscous fibre or with no added fibre. On the other hand, if the effect of a food on satiety-related subjective measures is related to multiple components, such as protein and fibre type/content, then the reference food should resemble as closely as possible the test food with respect to its composition, form, food category or use (for example, snack vs. meal). Moreover, the test food should be of equal or lower, but never of higher energy content (per serving) than the reference food.
5.3.4 The energy-free control, water, should match the test food in organoleptic characteristics (such as sweetness, palatability) only when the latter is in liquid form. For solid foods, the energy-free control preload could be plain water.
5.3.5 The evidence of an effect on satiety should be demonstrated for the serving of the food as consumed. The results obtained for a specific ingredient added to one food form are not necessarily transferable to other food forms. For this reason, the effect of the ingredient across foods of different forms (solid, semi-solid, liquid), macronutrient composition and amounts needs to be demonstrated.
5.4 Study Population
5.4.1 To substantiate a function claim, the study population should be adult individuals who are generally healthy and should be clearly defined in terms of subject inclusion/exclusion criteria. These criteria should provide assurance that subjects are suitable for the purpose of the study and are representative of the general population.
5.4.2 All confounders in the subject recruitment, screening, selection and analysis must be stated and justified.
5.5 Outcomes Used for the Substantiation of Satiety Claims
5.5.1 An effect of the test food on the primary outcome should be demonstrated using the appropriate statistical analysis (see section 5.6). Secondary outcomes should be of limited number and should support the primary outcome(s). Data on the measurements of satiety biomarkers (for example, gut hormones) can only be considered as supportive evidence and not referred to in the claim wording.
5.5.2 In order to support a satiety claim about subjective sensations and to cancel out possible variations in the intensity, duration, sensitivity or reliability of the measured parameters (for example, fullness, hunger), it is recommended, whenever possible, to use a mean score comprised of all VAS scales used in a study. Moreover, the results for all individual scales must be shown or described. In addition to the mean score being significantly improved with the test food, the exact claim wording must be based on a single scale (such as 'fullness', 'hunger') which itself was also significantly improved.
5.5.3 Comparative claims could be about the magnitude, or the duration of an effect, or both. In the first instance, the magnitude of the effect should be reported for the duration of the test. For example, if VAS were measured for 2 hours after the preloads, then the claim should state "A serving of product X is more filling than a serving of product Y for up to 2 hours". Claims about the duration of an effect should be comparative only with respect to the duration of the effect, such as "A serving of product X gives feelings of fullness longer than a serving of product Y", unless evidence of an effect of magnitude is also present, in which case the claim could read "A serving of product X is more filling and for longer than a serving of product Y".
5.5.4 For non-comparative claims about duration of an effect on subjective satiety measures (Example: "A serving of product X helps reduce the desire to eat for up to 4 hours"), the duration should be longer than what can usually be expected from the consumption of the food. As there are several intrinsic (including energy density, volume and macronutrient content) and extrinsic (including environmental and social cues) factors that influence subjective appetite-related sensations, it is difficult to establish a minimum number of hours that will be appropriate for such claims. However, it would be reasonable not to expect people to request food for at least 2 hours and 3 hours following the consumption of a snack or a meal, respectively. Therefore, to merit a claim, the duration of an effect of foods on subjective satiety measures should be at least 3 hours for a snack, or 4 hours for a meal. The duration of the effect should be evaluated as time to return to baseline subjective ratings where the baseline is defined as the value(s) prior to the consumption of the test food.
5.5.5 Because changes in appetite-related sensations do not always result in a net reduction in energy intake at a subsequent meal, it will not be required to demonstrate a lower energy intake after the test than after the reference food. However, the energy intake in the subsequent meal should be reduced by at least the energy value of the test or reference food. In other words, compensation for the energy of the test food at the subsequent meal should be at least 100%. Energy compensation is calculated as: EC% = (energy intake at the test meal after energy-free preload - energy intake at the test meal after test food) x 100 / energy content of test food preload. The rationale for this is to ensure that the consumption of the test food would not contribute to an increase in energy intake at the next meals relative to the lack of its consumption.
5.6 Statistical Analysis of Data
5.6.1 The study should be adequately powered to demonstrate a significant effect on the primary outcome(s) measured. The basis for sample size calculations should be the ability to detect at least 10% difference in satiety rating for the primary outcome between the test and control foods (for comparative claims), with a statistical significance at p≤0.05 and a power (β) of at least 80%. The primary outcome is the outcome that is the subject of the claim. Similar changes should also be observed in the composite mean of the subjective ratings.
5.6.2 For non-comparative claims, the duration of the effect is defined as the time interval between the consumption of the test food and the first time at which the mean score is not significantly different from the mean baseline score.
5.6.3 Proposed methods of statistical analysis should be planned prior to data collection and outlined at that time in sufficient detail to demonstrate the appropriateness of methods with respect to the objectives, the type of data and study design.
5.6.4 Satiety data analyses based on a single time measurement point do not consider that satiety responses are a function of time and are physiologically as well as statistically dependent (Blundell et al. 2010). Therefore, assessment of the satiety response should be done based on the total area under the curve (AUC) of a set of measurements for each of the parameters considered in the study with adjustment for the baseline by analysis of covariance (ANCOVA). For dealing with missing data, it is suggested to use the mixed model approach with analysis of covariance (RMANCOVA). Sources of variations (subjects, treatment, day of test, time of measure) and their interactions should be accounted for in the statistical analysis.
6.0 Claim Wording
Examples of acceptable and unacceptable claims can be found in Table 2.
6.1 As with all health claims, the potential benefit to the consumer should be clearly articulated in the claim in a manner that is well understood by the average consumer, as supported by consumer research.
6.2 The health claim should be based on the predefined primary outcome measured in the study. Claims based on post-hoc observations are unacceptable.
6.3 Claims stating or implying energy (caloric) intake or body weight effects would not be acceptable when they are based on study designs for assessing satiety effects described in this guidance.
6.4 For comparative claims, the foods stated in the claim should be those that have been compared in the study. If the claim refers to an added ingredient that is responsible for the satiety effect of the food, the amount of the ingredient per serving of stated size of the food should be declared.
|Type||Subjective Sensations (Satiety)|
|Comparative||Acceptable||Comparing magnitude of effect for a specific length of time (duration of effect must be included)
A serving [of stated size] of product X is more filling than a serving [of stated size] of product Y for up to 2 hours.
Comparing duration of effect
Comparing both magnitude and duration of effect
|Unacceptable||Product X increases feelings of fullness longer than product Y (amounts of products X and Y must be stated if the serving sizes are not the same).|
|Acceptable||A serving (of stated size) of X with Y grams of ingredient Z can suppress hunger longer than the same amount of X without ingredient Z.|
|Unacceptable||Ingredient Z helps suppress hunger (no comparator; extrapolation of the effect of an ingredient or generic macronutrient content across product types or forms cannot be made without supporting evidence).|
|Absolute (Non comparative)||Acceptable||A serving (of stated size) of X helps reduce the desire to eat for up to 4 hours.|
|Unacceptable||A serving (of stated size) of X is satisfying for up to 4 hours (vague and not an outcome based on VAS).|
|The serving sizes in brackets do not need to be stated if they are the same for the products being compared.|
7.1 Satiety health claims on foods are considered function claims and must be substantiated using human studies. Satiety claims should not directly or indirectly refer to energy (caloric) intake or body weight. Satiety claims should not be made on child-directed products.
7.2 The most commonly used and validated scales (Table 1) are currently the only method for self-report subjective rating of appetite-related sensations accepted by Health Canada for the substantiation of satiety health claims for foods Data on the measurements of satiety biomarkers could be considered as supporting evidence on the mechanism of action of the test food, but claims should neither be based on the effect on biomarkers nor worded to include reference to these biomarkers.
7.3 Satiety studies should be designed to clearly demonstrate the effect of the food as consumed and the results are not necessarily transferable to other categories of foods to which the specific ingredients could potentially be added. The claimed effect should be achieved by one serving of the food as stated in the Nutrition Facts table.
7.4 Satiety claims must be properly worded to reflect the effect of the food that is being supported by the experimental data. Satiety values such as satiety index, satiating efficiency and satiety quotient are currently not acceptable. However, Health Canada encourages further research in this area.
7.5 Given the limitations of the current methodology, the guidance in this document will warrant an update when the research on appetite measurement evolves towards improved validated methodologies.
Comments on this document may be submitted in writing electronically, between September 14 and November 12, 2012, to email@example.com. Please use the words "satiety-satiété" in the subject line of your e-mail. Comments must be received by 11:59 p.m. EST, November 11, 2012.
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