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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01806688
Other study ID # H2013:036
Secondary ID RRC/2013/1276
Status Completed
Phase N/A
First received
Last updated
Start date July 6, 2013
Est. completion date August 23, 2014

Study information

Verified date August 2021
Source St. Boniface Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 46
Est. completion date August 23, 2014
Est. primary completion date August 23, 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 70 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
gluten-free high protein snack #1
buckwheat groats 30g serving
gluten-free snack with similar energy density but 1/2 the protein as snack #1
32g serving of corn nuts
non-caloric control
water
gluten-free high protein and high fibre snack #2
buckwheat and pinto bean flour pita bread 50g serving
gluten-free snack with similar energy density, but less protein and fibre than snack #2
50g serving of rice bread

Locations

Country Name City State
Canada I. H. Asper Clinical Research Institute Winnipeg Manitoba

Sponsors (2)

Lead Sponsor Collaborator
St. Boniface Hospital Manitoba Agri-Health Research Network

Country where clinical trial is conducted

Canada, 

References & Publications (3)

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. Review. — View Citation

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. Review. — View Citation

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. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Gastrointestinal Side Effects Participants were asked if they noticed any gastrointestinal side effects after having eaten the study food and the results were recorded. 24h
Other Likeability of Test and Reference Products Based on Sensory Scales 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
Primary Total Area Under the Curve (AUC) for Hunger, Fullness, Desire to Eat and Prospective Consumption Using Visual Analog Scales (VAS) 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 Number of Calories Consumed Post-snack Until Bedtime 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)
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