- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01806688
Effect of Snacks on Appetite Control
August 11, 2021 updated by: Dr. Heather Blewett, St. Boniface Hospital
A Randomized, Controlled, Cross-over Study of the Effect of Snacks on Appetite Control
This clinical trial is being conducted to study whether eating certain snacks will reduce your desire to eat and for a longer period of time compared to other snacks.
The investigators are testing 2 different snacks.
Study #1 will involve eating 2 different seed-like snacks or water.
Study #2 will involve eating pita bread with jam, bread with jam or water.
The test snack is higher in protein and/or fibre compared to the reference product.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
- Other: gluten-free high protein snack #1
- Other: gluten-free snack with similar energy density but 1/2 the protein as snack #1
- Other: non-caloric control
- Other: gluten-free high protein and high fibre snack #2
- Other: gluten-free snack with similar energy density, but less protein and fibre than snack #2
Detailed Description
Healthy adults will be recruited to participate in a randomized, controlled, crossover study to investigate whether or not eating snacks made with buckwheat would increase satiety and reduce their energy intake when compared to a comparable snack.
Water was included as a non-caloric control.
The study consisted of 3 visits and participants would receive a different treatment at each visit.
Visits were scheduled at least 7 days apart.
Visual analog scales will be used to assess appetite related sensations at 7 time points, fasting, 30 minutes after consuming the snack and then at 30 minute intervals for 180 minutes.
Participants will be provided with a lunch and the amount of food consumed will be weighed.
I addition, participants will be asked to maintain a food record for the remainder of the day.
Study Type
Interventional
Enrollment (Actual)
46
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Manitoba
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Winnipeg, Manitoba, Canada, R2H 2A6
- I. H. Asper Clinical Research Institute
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Body mass index 18-30kg/m2
- males and non-pregnant or non-lactating females
Exclusion Criteria:
- Diagnosis of disease by a medical doctor that requires medical treatment during the study period.
- Daily tobacco use.
- Physical Activity Level >1.8.
- Eat meals at irregular or unusual times.
- Food allergy, aversion or unwillingness to eat study foods.
- Use of any prescription or non-prescription drug, herbal or nutritional supplement known to affect appetite.
- Presence of a gastrointestinal disorder.
- Score >65% on any 1 of the 3 categories of the Three Factor Eating Questionnaire-R18.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental Snack #1
One of three interventions to be administered at each visit, an experimental snack, a placebo comparator reference product or a placebo comparator non-caloric control.
The experimental snack #1 is a gluten-free high protein snack comprised of a 30g serving of buckwheat groats.
The placebo comparator reference product is a gluten-free snack with similar energy density, but 1/2 the protein as snack #1, comprised of a 32g serving of corn nuts.
The placebo comparator non-caloric control is water.
|
buckwheat groats 30g serving
32g serving of corn nuts
water
|
Experimental: Experimental Snack #2
One of three interventions to be administered at each visit, an experimental snack, a placebo comparator reference product or a placebo comparator non-caloric control.
The experimental snack #2 is a gluten-free high protein and high fibre snack comprised of a 50g serving of a buckwheat and pinto bean flour pita bread.
The placebo comparator reference product is a gluten-free snack with similar energy density, but less protein and fibre than snack #2, comprised of a 50g serving of rice bread.
The placebo comparator non-caloric control is water.
|
water
buckwheat and pinto bean flour pita bread 50g serving
50g serving of rice bread
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total Area Under the Curve (AUC) for Hunger, Fullness, Desire to Eat and Prospective Consumption Using Visual Analog Scales (VAS)
Time Frame: VAS administered pre-snack and then every 30 minutes after the first bite up to 180 minutes for a total of 7 time points.
|
Appetite assessment was measured using a VAS questionnaire administered pre-snack and every 30 minutes post snack up to 180 minutes, for a total of 7 time points.
The questionnaire included 4 questions (1) How hungry are you?
(2) How full are you?
(3) How strong is your desire to eat? (4) How much do you think you want to eat right now?
Each question was followed by a 10 cm line anchored at the left and right ends by the opposing statements "not at all" and "extremely" for questions 1 and 2, "very weak " and "very strong" for question 3, and "nothing at all" and "a very large amount" for question 4. Participants provided their response to each question by marking a perpendicular line on the 10-cm line to indicate their answer.
Scores were determined by measuring the distance in centimeters from the left anchor to the perpendicular line drawn by the participant.
VAS scores over time were graphed and AUC was calculated using the trapezoid method.
|
VAS administered pre-snack and then every 30 minutes after the first bite up to 180 minutes for a total of 7 time points.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Calories Consumed Post-snack Until Bedtime
Time Frame: time between snack consumption and bedtime (12 hours)
|
Participants were provided with a food diary to record the amount and type of each food and beverage consumed for the remainder of the day.
Energy consumed at lunch and the remainder of the day were quantified from food consumed at lunch and the food diary using Food Processor Nutrient Analysis Software.
|
time between snack consumption and bedtime (12 hours)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Gastrointestinal Side Effects
Time Frame: 24h
|
Participants were asked if they noticed any gastrointestinal side effects after having eaten the study food and the results were recorded.
|
24h
|
Likeability of Test and Reference Products Based on Sensory Scales
Time Frame: immediately after eating test or reference product
|
Likability of the study products was assessed using a 5-point hedonic scale (1 = dislike extremely; 2 = dislike very moderately; 3 = neither like or dislike; 4 = like moderately; 5 = like extremely) for appearance, aroma, flavour, taste, texture and overall liking.
|
immediately after eating test or reference product
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Heather J Blewett, PhD, St. Boniface Hospital Research Centre
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Blundell J, de Graaf C, Hulshof T, Jebb S, Livingstone B, Lluch A, Mela D, Salah S, Schuring E, van der Knaap H, Westerterp M. Appetite control: methodological aspects of the evaluation of foods. Obes Rev. 2010 Mar;11(3):251-70. doi: 10.1111/j.1467-789X.2010.00714.x. Epub 2010 Jan 29.
- Paddon-Jones D, Westman E, Mattes RD, Wolfe RR, Astrup A, Westerterp-Plantenga M. Protein, weight management, and satiety. Am J Clin Nutr. 2008 May;87(5):1558S-1561S. doi: 10.1093/ajcn/87.5.1558S.
- Belski R. Fiber, protein, and lupin-enriched foods: role for improving cardiovascular health. Adv Food Nutr Res. 2012;66:147-215. doi: 10.1016/B978-0-12-394597-6.00004-5.
Helpful Links
- Obesity in Canada: A joint report from the Public Health Agency of Canada and the Canadian Institute for Health Information
- Guidance on the scientific requirements for health claims related to appetite ratings, weight management, and blood glucose concentrations
- Draft guidance document: Satiety health claims on food from Health Canada
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 6, 2013
Primary Completion (Actual)
August 23, 2014
Study Completion (Actual)
August 23, 2014
Study Registration Dates
First Submitted
March 5, 2013
First Submitted That Met QC Criteria
March 6, 2013
First Posted (Estimate)
March 7, 2013
Study Record Updates
Last Update Posted (Actual)
August 12, 2021
Last Update Submitted That Met QC Criteria
August 11, 2021
Last Verified
August 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- H2013:036
- RRC/2013/1276 (Other Identifier: Research Review Committee)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Group results will be emailed or mailed to individuals upon request once they are available.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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