Clinical trial NCT01806688: Effect of Snacks on Appetite Control
Official title: A Randomized, Controlled, Cross-over Study of the Effect of Snacks on Appetite Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Canadians
Appetite Control
Keywords: satiety
appetite
snack
Lead sponsor: St. Boniface Hospital
Sponsor class: OTHER
Collaborators: name: Manitoba Agri-Health Research Network
First posted: 2013-03-07
Enrollment: 46
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized crossover
Primary purpose: OTHER

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Total Area Under the Curve (AUC) for Hunger, Fullness, Desire to Eat and Prospective Consumption Using Visual Analog Scales (VAS)
timeFrame: 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 outcomes:
measure: Number of Calories Consumed Post-snack Until Bedtime
timeFrame: time between snack consumption and bedtime (12 hours)
Other outcomes:
measure: Gastrointestinal Side Effects
timeFrame: 24h
measure: Likeability of Test and Reference Products Based on Sensory Scales
timeFrame: immediately after eating test or reference product
Locations:
city: Winnipeg
country: Canada
facility: I. H. Asper Clinical Research Institute
state: Manitoba
Study officials:
affiliation: St. Boniface Hospital Research Centre
name: Heather J Blewett, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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. doi: 10.1093/ajcn/87.5.1558S.
citation: 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.