EatingCOLLATIONNCT01141140
(Mis)Perceptions About Healthy Eating: Effects on Food Intake and Appetite in Men and Women
A study testing Healthy, Diet and Unhealthy in people with Eating and Obesity, run by Laval University at 1 site in Canada.
Trial summary
In the face of an increased prevalence of obesity and chronic diseases in Canada, much effort has been invested to educate the population about healthy eating. Although Canadians are now aware of the importance of healthier food habits, rates of obesity and chronic diseases are still increasing. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- What is being tested?
- Healthy, Diet and Unhealthy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 355 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2009to Dec 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Stable weight (± 2.5 kg) for at least 2 months prior to the study.
- Females will be tested in the follicular phase of their menstrual cycle to control for potential impact of hormonal variation on appetite measurements and food intake.
Who cannot join
- They will not be taking medication (e.g., corticosteroids, tricyclic antidepressants, atypical antipsychotics) and not present chronic health problems (e.g., eating disorders, diabetes, hyperthyroidism).
- No pregnant women nor lactating women.
- Aversion to the snack food used in the study.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Institute of Nutraceuticals and Functionnal Foods (INAF)
Québec, Quebec, G1V 0A6
About this study
In the face of an increased prevalence of obesity and chronic diseases in Canada, much effort has been invested to educate the population about healthy eating. Although Canadians are now aware of the importance of healthier food habits, rates of obesity and chronic diseases are still increasing. In addition, even if different labelling strategies are used to identify healthier foods in the market, consumers remain confused about what healthy eating should be. Might describing foods as healthy have unintended side-effects on food intake? Previous literature has shown that perceptions about the healthiness of foods may bias estimations of caloric content of foods, leading consumers to underestimate the caloric content of "healthy" food choices. Indeed, the investigators have recently shown that perceiving a food as healthy increased intake of that food by 35% in undergraduate female students. The general objective of the proposed research is to investigate whether food perceptions influence intake and appetite sensations in normal-weight and overweight/obese restrained and unrestrained males and females. This laboratory study, in which perceived healthiness and "fatteningness" of oatmeal-raisin cookies will be manipulated during an ad libitum single-meal occasion, will increase the investigators knowledge of the effects of external cues (and other psychological and physiological factors) on the control of food intake. Because the popularity and demand for nutrition information is increasing, such information is needed to improve clinical practices aiming at promoting sustainable healthy eating habits to help individuals achieve and maintain a healthy weight.
Read the detailed description
The laboratory study will be conducted at the Clinical Investigation Unit (CIU) of the Institute of Nutraceuticals and Functional Foods (INAF). Food-related variables (perceived healthiness and "fatteningness" of foods) will be manipulated during an ad libitum single-meal test. We will examine the effects of these variables on food intake and appetite sensations in male and female normal-weight and overweight/obese restrained and unrestrained eaters. Each participant will be tested on an individual basis, during a 2-hour experimental session (randomized sessions between 11:00 a.m. and 5:00 p.m.). Because participants might change their eating behaviors if they become aware of the true purpose of the study, deception must be used. Males and females will thus be recruited to participate in an ostensible market-research study involving a taste-rating task, and each participant will then be carefully debriefed at the end of the experiment.
Male and female normal-weight with a body mass index (BMI) ≥18.5kg/m2 and <25kg/m2 and overweight/obese with a BMI ≥25kg/m2, restrained and unrestrained eaters will be randomly assigned to one of three experimental conditions ("healthy," "diet," and "unhealthy"). A plate of about 1000 grams (g) of bite-sized oatmeal-raisin cookies will be presented to each participant. On average, one bite-size cookie is about 10g, which represents approximately 40 kilocalories (kcal) per cookie. The manipulation of healthiness and "fatteningness" perceptions of the oatmeal-raisin cookies will be performed verbally by the experimenter as follows. In the "healthy" condition, the description will emphasize nutritional characteristics (e.g., high in fibre, low in saturated fat and free from trans-fat), so the overall healthiness of the snack will be highlighted. In the "diet" condition, the description will emphasize the benefits of oatmeal fibre for weight management (e.g., helps to cope with hunger), thereby highlighting the weight-loss potential of the snack. In the "unhealthy" condition, the description will emphasize hedonic characteristics of the food and less healthy ingredients (e.g. gourmet cookies, contains butter and sugar), so some inherent unhealthy aspects of the snack will be highlighted.
Males and females involved in the study will be invited to participate in a market-research study investigating various dimensions of a new snack product. A telephone screening interview will first be conducted for all subjects interested in participating in the study to ensure that they meet our inclusion criteria, to facilitate randomization prior to the experiment session and to set the appointment with the participant. During this interview, each participant will be informed that this market-research study involves a taste-rating task in which they will taste and rate a new snack food. They will have to self-report their weight and height, and answer descriptive questions about inclusion criteria (e.g., history of health problems, current medications, liking of the tested food, and prior participation in studies). They will also have to complete the Restraint Scale to assess whether they exhibit behavioral and attitudinal concerns about dieting and weight control. Each participant will then be categorized as a restrained eater (≥12 in males and ≥15 in females) or unrestrained eater (<12 in males and <15 in females). Following the categorization established by the Restraint Scale and BMI calculation, each participant will then be randomly assigned to one of the experimental conditions, according to restraint and weight status (Note that randomization will be adjusted according to the measured BMI). The telephone screening interview will be conducted at least one week prior to the appointment at the CIU to ensure that having been asked about restraint and weight status will not affect participants' food intake and appetite sensations by making restraint and weight salient during the experiment. To standardize food intake and to insure that subjects have comparable baseline appetite sensations across experimental manipulations, participants will be asked to refrain from eating oatmeal-raisin cookies (tested food) for at least 24 hours prior to the experiment, and to arrive at the CIU for the appointment in a pre-meal state (i.e., at least 2 hours without food prior to the experiment). Because physical activity might have an impact on appetite sensations, participants will also be asked to refrain from doing any strenuous exercise at least for 24 hours before the experiment. Note that the experimenter in the study will strictly follow a detailed script when testing each participant to ensure that the testing will be consistent between all participants.
- Being tested
- Healthy, Diet, Unhealthy
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HealthyBehavioural
Favourable nutritional characteristics.
DietBehavioural
Benefits of an ingredient/nutrient for weight management
UnhealthyBehavioural
Hedonic characteristics and less healthy ingredients.
| Study group | Role | What they receive |
|---|---|---|
| M-NO-NR | Other | Men (M) non-obese (NO) and non-restrained (NR). Receives: Behavioral: Healthy; Behavioral: Diet; Behavioral: Unhealthy |
| M-NO-R | Other | Men (M) non-obese (NO) and restrained (R). Receives: Behavioral: Healthy; Behavioral: Diet; Behavioral: Unhealthy |
| M-O-NR | Other | Men (M) overweight or obese (O) and non-restrained (NR). Receives: Behavioral: Healthy; Behavioral: Diet; Behavioral: Unhealthy |
| M-O-R | Other | Men (M) overweight or obese (O) and restrained (R). Receives: Behavioral: Healthy; Behavioral: Diet; Behavioral: Unhealthy |
| W-NO-NR | Other | Women (W) non-obese (NO) and non-restrained (NR). Receives: Behavioral: Healthy; Behavioral: Diet; Behavioral: Unhealthy |
| W-NO-R | Other | Women (W) non-obese (NO) and restrained (R). Receives: Behavioral: Healthy; Behavioral: Diet; Behavioral: Unhealthy |
| W-O-NR | Other | Women (W) overweight or obese (O) and non-restrained (NR). Receives: Behavioral: Healthy; Behavioral: Diet; Behavioral: Unhealthy |
| W-O-R | Other | Women (W) overweight or obese (O) and restrained (R). Receives: Behavioral: Healthy; Behavioral: Diet; Behavioral: Unhealthy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Single-meal intake
The amount of food eaten during the meal (grams and calories).
Measured: 12-24-2010
Secondary outcomes (1)
Appetite sensations
Visual-analogue ratings of desire to eat, hunger, fullness, and prospective food consumption (measured in millimeters).
Measured: 12-24-2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2010 (estimated)
- Study startSep 2009
- Primary completionDec 2010
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EatingStudies of the same condition, open and under way.
- More trials run by Laval UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 355 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Fonds de la Recherche en Santé du Québec, Danone Institute International
- Responsible party
- Principal investigator, Véronique Provencher, Laval University
- Investigators
- Veronique Provencher, PhD, Principal investigator, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01141140
- Sponsor's protocol ID
- INAF 2009-117
- Acronym
- COLLATION
- Status last verified
- Feb 2012
- First submitted
- 9 Jun 2010
- Last updated
- 14 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- (Mis)Perceptions About Healthy Eating: Effects on Food Intake and Appetite in Men and Women
- ClinicalTrials.gov ID
- NCT01141140
- Acronym / sponsor ID
- COLLATION / INAF 2009-117
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 355 participants (actual)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Fonds de la Recherche en Santé du Québec, Danone Institute International
- Study start
- Sep 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 10 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In the face of an increased prevalence of obesity and chronic diseases in Canada, much effort has been invested to educate the population about healthy eating. Although Canadians are now aware of the importance of healthier food habits, rates of obesity and chronic diseases are still increasing. In addition, even if different labelling strategies are used to identify healthier foods in the market, consumers remain confused about what healthy eating should be. Might describing foods as healthy have unintended side-effects on food intake? Previous literature has shown that perceptions about the healthiness of foods may bias estimations of caloric content of foods, leading consumers to underestimate the caloric content of "healthy" food choices. Indeed, the investigators have recently shown that perceiving a food as healthy increased intake of that food by 35% in undergraduate female students. The general objective of the proposed research is to investigate whether food perceptions influence intake and appetite sensations in normal-weight and overweight/obese restrained and unrestrained males and females. This laboratory study, in which perceived healthiness and "fatteningness" of oatmeal-raisin cookies will be manipulated during an ad libitum single-meal occasion, will increase the investigators knowledge of the effects of external cues (and other psychological and physiological factors) on the control of food intake. Because the popularity and demand for nutrition information is increasing, such information is needed to improve clinical practices aiming at promoting sustainable healthy eating habits to help individuals achieve and maintain a healthy weight.
Detailed description
The laboratory study will be conducted at the Clinical Investigation Unit (CIU) of the Institute of Nutraceuticals and Functional Foods (INAF). Food-related variables (perceived healthiness and "fatteningness" of foods) will be manipulated during an ad libitum single-meal test. We will examine the effects of these variables on food intake and appetite sensations in male and female normal-weight and overweight/obese restrained and unrestrained eaters. Each participant will be tested on an individual basis, during a 2-hour experimental session (randomized sessions between 11:00 a.m. and 5:00 p.m.). Because participants might change their eating behaviors if they become aware of the true purpose of the study, deception must be used. Males and females will thus be recruited to participate in an ostensible market-research study involving a taste-rating task, and each participant will then be carefully debriefed at the end of the experiment.
Male and female normal-weight with a body mass index (BMI) ≥18.5kg/m2 and <25kg/m2 and overweight/obese with a BMI ≥25kg/m2, restrained and unrestrained eaters will be randomly assigned to one of three experimental conditions ("healthy," "diet," and "unhealthy"). A plate of about 1000 grams (g) of bite-sized oatmeal-raisin cookies will be presented to each participant. On average, one bite-size cookie is about 10g, which represents approximately 40 kilocalories (kcal) per cookie. The manipulation of healthiness and "fatteningness" perceptions of the oatmeal-raisin cookies will be performed verbally by the experimenter as follows. In the "healthy" condition, the description will emphasize nutritional characteristics (e.g., high in fibre, low in saturated fat and free from trans-fat), so the overall healthiness of the snack will be highlighted. In the "diet" condition, the description will emphasize the benefits of oatmeal fibre for weight management (e.g., helps to cope with hunger), thereby highlighting the weight-loss potential of the snack. In the "unhealthy" condition, the description will emphasize hedonic characteristics of the food and less healthy ingredients (e.g. gourmet cookies, contains butter and sugar), so some inherent unhealthy aspects of the snack will be highlighted.
Males and females involved in the study will be invited to participate in a market-research study investigating various dimensions of a new snack product. A telephone screening interview will first be conducted for all subjects interested in participating in the study to ensure that they meet our inclusion criteria, to facilitate randomization prior to the experiment session and to set the appointment with the participant. During this interview, each participant will be informed that this market-research study involves a taste-rating task in which they will taste and rate a new snack food. They will have to self-report their weight and height, and answer descriptive questions about inclusion criteria (e.g., history of health problems, current medications, liking of the tested food, and prior participation in studies). They will also have to complete the Restraint Scale to assess whether they exhibit behavioral and attitudinal concerns about dieting and weight control. Each participant will then be categorized as a restrained eater (≥12 in males and ≥15 in females) or unrestrained eater (<12 in males and <15 in females). Following the categorization established by the Restraint Scale and BMI calculation, each participant will then be randomly assigned to one of the experimental conditions, according to restraint and weight status (Note that randomization will be adjusted according to the measured BMI). The telephone screening interview will be conducted at least one week prior to the appointment at the CIU to ensure that having been asked about restraint and weight status will not affect participants' food intake and appetite sensations by making restraint and weight salient during the experiment. To standardize food intake and to insure that subjects have comparable baseline appetite sensations across experimental manipulations, participants will be asked to refrain from eating oatmeal-raisin cookies (tested food) for at least 24 hours prior to the experiment, and to arrive at the CIU for the appointment in a pre-meal state (i.e., at least 2 hours without food prior to the experiment). Because physical activity might have an impact on appetite sensations, participants will also be asked to refrain from doing any strenuous exercise at least for 24 hours before the experiment. Note that the experimenter in the study will strictly follow a detailed script when testing each participant to ensure that the testing will be consistent between all participants.
Study design
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| M-NO-NR | Other | Behavioral: Healthy, Behavioral: Diet, Behavioral: UnhealthyMen (M) non-obese (NO) and non-restrained (NR). |
| M-NO-R | Other | Behavioral: Healthy, Behavioral: Diet, Behavioral: UnhealthyMen (M) non-obese (NO) and restrained (R). |
| M-O-NR | Other | Behavioral: Healthy, Behavioral: Diet, Behavioral: UnhealthyMen (M) overweight or obese (O) and non-restrained (NR). |
| M-O-R | Other | Behavioral: Healthy, Behavioral: Diet, Behavioral: UnhealthyMen (M) overweight or obese (O) and restrained (R). |
| W-NO-NR | Other | Behavioral: Healthy, Behavioral: Diet, Behavioral: UnhealthyWomen (W) non-obese (NO) and non-restrained (NR). |
| W-NO-R | Other | Behavioral: Healthy, Behavioral: Diet, Behavioral: UnhealthyWomen (W) non-obese (NO) and restrained (R). |
| W-O-NR | Other | Behavioral: Healthy, Behavioral: Diet, Behavioral: UnhealthyWomen (W) overweight or obese (O) and non-restrained (NR). |
| W-O-R | Other | Behavioral: Healthy, Behavioral: Diet, Behavioral: UnhealthyWomen (W) overweight or obese (O) and restrained (R). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Stable weight (± 2.5 kg) for at least 2 months prior to the study.
- Females will be tested in the follicular phase of their menstrual cycle to control for potential impact of hormonal variation on appetite measurements and food intake.
Key exclusion criteria (3 listed)
- They will not be taking medication (e.g., corticosteroids, tricyclic antidepressants, atypical antipsychotics) and not present chronic health problems (e.g., eating disorders, diabetes, hyperthyroidism).
- No pregnant women nor lactating women.
- Aversion to the snack food used in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HealthyFavourable nutritional characteristics. | Behavioural | M-NO-NR, M-NO-R, M-O-NR, M-O-R, W-NO-NR, W-NO-R, W-O-NR, W-O-R |
| DietBenefits of an ingredient/nutrient for weight management | Behavioural | M-NO-NR, M-NO-R, M-O-NR, M-O-R, W-NO-NR, W-NO-R, W-O-NR, W-O-R |
| UnhealthyHedonic characteristics and less healthy ingredients. | Behavioural | M-NO-NR, M-NO-R, M-O-NR, M-O-R, W-NO-NR, W-NO-R, W-O-NR, W-O-R |
Primary outcome
Single-meal intake
Time frame: 12-24-2010
The amount of food eaten during the meal (grams and calories).
1 secondary outcome
Appetite sensations
Time frame: 12-24-2010
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Veronique Provencher, PhD principal investigator
Laval University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healthy, Diet and Unhealthy in people with Eating and Obesity, run by Laval University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Single-meal intake (time frame: 12-24-2010). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2012.