ObesityMENUNCT01604954
Does Food Labeling Influence Long-term Food Intake and Eating-related Variables in Women?
A study testing Nutrient-label, Calorie-label and No label in people with Obesity, run by Laval University at 1 site in Canada.
Trial summary
Weight management is a critical issue in developed countries where the prevalence of obesity is always increasing. While the mismatch of energy intake and energy expenditure is recognized as a leading cause of obesity, knowledge related to the determinants of healthy eating patterns are still an important issue to… Read more about this study
- Who is it for?
- Ages 25 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Nutrient-label, Calorie-label and No label
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2011to Apr 2015
- 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 25 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- stable weight (± 2.5 kg) for at least 3 months prior to the study.
- BMI between 18.5 and 25 kg/m2 for the non-obese group and BMI between 30 and 40 kg/m2 for the obese group.
Who cannot join
- pregnant or lactating.
- aversion to the foods in the study.
- taking medication (e.g., corticosteroids,tricyclic antidepressants, atypical antipsychotics) and present chronic health problems (e.g.,food allergies, eating disorders, diabetes, hyperthyroidism) that could affect appetite measurements and food intake.
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
Weight management is a critical issue in developed countries where the prevalence of obesity is always increasing. While the mismatch of energy intake and energy expenditure is recognized as a leading cause of obesity, knowledge related to the determinants of healthy eating patterns are still an important issue to further address. Various nutrition-education campaigns have been implemented as a way to increase knowledge about healthy foods and facilitate the adoption of better eating behaviors. There is currently social and politic pressure on health authorities to increase availability of nutrition information as a way to tackle the obesity epidemic. Does nutrition information on food labels really contribute to improving dietary intake among the population and to helping them to better manage their body weight? Some evidence suggests that describing foods as healthy might have unintended enhancement effects on the acute amount of food and calories consumed. A better understanding of how and why nutrient and calorie labels influence acute and chronic intake is thus needed. This study investigate how providing nutritional information on food labels influences intake and eating-related variables over a 10-day period among women characterized by varying levels of adiposity. As it has never been investigated before, the present research will provide important knowledge on the long-term impacts of different food labeling strategies on the regulation of food intake. It will also help to determine whether weight status could influence the effects of perceptions about foods on intake, so that the investigators can identify individuals who mostly tend to overeat in specific situations. Consumer advocacy organizations are urging government to adopt policies regarding food labeling. Such research is thus of great relevance for the promotion of healthy body weight at the population level, as it will clearly contribute to assess how food labels should be used by health governing bodies in the context of the obesity epidemic.
Read the detailed description
Much effort has been invested to educate Canadians about the importance of healthy eating and active living. Various food labeling strategies are currently used (e.g. nutrient-content claims approved by Health Canada), or strongly suggested (e.g. calorie information on restaurant menus), as tools to increase knowledge about healthy food choices and to help consumers make more so-called healthier choices. Does nutrition information on food labels really contribute to improve dietary intakes among the population? Some evidence does suggest that food labeling could influence consumer's choices and purchases. But, consumers remain confused about what healthy eating should be, and about how many calories they should be eating per day. Data suggest that only 50% of them truly understand and use food labels. Results regarding the impact of food labeling on intake are less convincing. We have recently shown that perceiving a snack food as healthy increased intake of that food by 35% in female students. Health halos promoted by nutrition information may lead consumers to draw misleading inferences from food labels. Considering current public pressure on health authorities to increased availability of nutrition information as a way to attack the obesity epidemic, long-term impact of food labeling strategies on food intake regulation represents a critical key issue that have not been yet investigated.
The general objective of the present research proposal is to investigate how providing nutritional information on food labels influences intake and eating-related variables over a 10-day period among women. We will more specifically:
- Compare the impact of 1) nutrient quality and 2) calorie content food labels vs. "no label" condition on mean ad libitum intake and appetite sensations before/after meals over a 10-day period in women.
- Examine how body weight (normal versus obesity) influences the impact of the nutrient quality and calorie content food labels on mean ad libitum intake and appetite sensations over a 10-day period in women.
- Verify whether types of food labels influence attitudes towards meals offered (i.e. perceived healthiness, appropriateness, palatability) over a 10-day period in women.
- Conditions
- Obesity
- Being tested
- Nutrient-label, Calorie-label, No label
- Keywords
- Food labeling
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrient-labelBehavioural
A label indicating that the lunch they will eat is low in saturated fat and free from trans fat will be posted on the containers.
Calorie-labelBehavioural
A label indicating the amount of calories for a fixed serving plus information about daily caloric requirement ("The recommended daily caloric intake for an average adult is 2000 calories") will be posted on the containers.
No labelBehavioural
Lunches will be free from labels, so that no nutritional information will be provided to the participants(control group).
| Study group | Role | What they receive |
|---|---|---|
| Non-obese | Other | Non-obese women (BMI between 18.5 and 25 kg/m2) Receives: Behavioral: Nutrient-label; Behavioral: Calorie-label; Behavioral: No label |
| Obese | Other | Obese women (BMI between 30 and 40 kg/m2) Receives: Behavioral: Nutrient-label; Behavioral: Calorie-label; Behavioral: No label |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean ad libitum intake
The mean amount per day of food eaten during the 10-day period (grams and calories).
Measured: Up to 2 years after the beginning of the study
Secondary outcomes (1)
Appetite sensations
Visual-analogue ratings of hunger and fullness(measured in millimeters) before and after each meal.
Measured: Up to 2 years after the beginning of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2012 (estimated)
- Study startAug 2011
- Primary completionMay 2013
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Véronique Provencher, Laval University
- Investigators
- Véronique Provencher, Ph.D., Principal investigator, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01604954
- Sponsor's protocol ID
- INAF 2011-088
- Acronym
- MENU
- Status last verified
- Aug 2015
- First submitted
- 16 May 2012
- Last updated
- 1 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Food Labeling Influence Long-term Food Intake and Eating-related Variables in Women?
- ClinicalTrials.gov ID
- NCT01604954
- Acronym / sponsor ID
- MENU / INAF 2011-088
- Conditions
- Obesity
- Keywords
- Food labeling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Aug 2011
- Primary completion
- May 2013 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 24 May 2012 (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.
Weight management is a critical issue in developed countries where the prevalence of obesity is always increasing. While the mismatch of energy intake and energy expenditure is recognized as a leading cause of obesity, knowledge related to the determinants of healthy eating patterns are still an important issue to further address. Various nutrition-education campaigns have been implemented as a way to increase knowledge about healthy foods and facilitate the adoption of better eating behaviors. There is currently social and politic pressure on health authorities to increase availability of nutrition information as a way to tackle the obesity epidemic. Does nutrition information on food labels really contribute to improving dietary intake among the population and to helping them to better manage their body weight? Some evidence suggests that describing foods as healthy might have unintended enhancement effects on the acute amount of food and calories consumed. A better understanding of how and why nutrient and calorie labels influence acute and chronic intake is thus needed. This study investigate how providing nutritional information on food labels influences intake and eating-related variables over a 10-day period among women characterized by varying levels of adiposity. As it has never been investigated before, the present research will provide important knowledge on the long-term impacts of different food labeling strategies on the regulation of food intake. It will also help to determine whether weight status could influence the effects of perceptions about foods on intake, so that the investigators can identify individuals who mostly tend to overeat in specific situations. Consumer advocacy organizations are urging government to adopt policies regarding food labeling. Such research is thus of great relevance for the promotion of healthy body weight at the population level, as it will clearly contribute to assess how food labels should be used by health governing bodies in the context of the obesity epidemic.
Detailed description
Much effort has been invested to educate Canadians about the importance of healthy eating and active living. Various food labeling strategies are currently used (e.g. nutrient-content claims approved by Health Canada), or strongly suggested (e.g. calorie information on restaurant menus), as tools to increase knowledge about healthy food choices and to help consumers make more so-called healthier choices. Does nutrition information on food labels really contribute to improve dietary intakes among the population? Some evidence does suggest that food labeling could influence consumer's choices and purchases. But, consumers remain confused about what healthy eating should be, and about how many calories they should be eating per day. Data suggest that only 50% of them truly understand and use food labels. Results regarding the impact of food labeling on intake are less convincing. We have recently shown that perceiving a snack food as healthy increased intake of that food by 35% in female students. Health halos promoted by nutrition information may lead consumers to draw misleading inferences from food labels. Considering current public pressure on health authorities to increased availability of nutrition information as a way to attack the obesity epidemic, long-term impact of food labeling strategies on food intake regulation represents a critical key issue that have not been yet investigated.
The general objective of the present research proposal is to investigate how providing nutritional information on food labels influences intake and eating-related variables over a 10-day period among women. We will more specifically:
- Compare the impact of 1) nutrient quality and 2) calorie content food labels vs. "no label" condition on mean ad libitum intake and appetite sensations before/after meals over a 10-day period in women.
- Examine how body weight (normal versus obesity) influences the impact of the nutrient quality and calorie content food labels on mean ad libitum intake and appetite sensations over a 10-day period in women.
- Verify whether types of food labels influence attitudes towards meals offered (i.e. perceived healthiness, appropriateness, palatability) over a 10-day period in women.
Study design
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-obese | Other | Behavioral: Nutrient-label, Behavioral: Calorie-label, Behavioral: No labelNon-obese women (BMI between 18.5 and 25 kg/m2) |
| Obese | Other | Behavioral: Nutrient-label, Behavioral: Calorie-label, Behavioral: No labelObese women (BMI between 30 and 40 kg/m2) |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- stable weight (± 2.5 kg) for at least 3 months prior to the study.
- BMI between 18.5 and 25 kg/m2 for the non-obese group and BMI between 30 and 40 kg/m2 for the obese group.
Key exclusion criteria (3 listed)
- pregnant or lactating.
- aversion to the foods in the study.
- taking medication (e.g., corticosteroids,tricyclic antidepressants, atypical antipsychotics) and present chronic health problems (e.g.,food allergies, eating disorders, diabetes, hyperthyroidism) that could affect appetite measurements and food intake.
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 |
|---|---|---|
| Nutrient-labelA label indicating that the lunch they will eat is low in saturated fat and free from trans fat will be posted on the containers. | Behavioural | Non-obese, Obese |
| Calorie-labelA label indicating the amount of calories for a fixed serving plus information about daily caloric requirement ("The recommended daily caloric intake for an average adult is 2000 calories") will be posted on the containers. | Behavioural | Non-obese, Obese |
| No labelLunches will be free from labels, so that no nutritional information will be provided to the participants(control group). | Behavioural | Non-obese, Obese |
Primary outcome
Mean ad libitum intake
Time frame: Up to 2 years after the beginning of the study
The mean amount per day of food eaten during the 10-day period (grams and calories).
1 secondary outcome
Appetite sensations
Time frame: Up to 2 years after the beginning of the study
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 1 Sep 2015.
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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.
Véronique Provencher, Ph.D. 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 Nutrient-label, Calorie-label and No label in people with 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 1 Sep 2015. 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?
Mean ad libitum intake (time frame: Up to 2 years after the beginning of the study). 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 1 Sep 2015.