Overview

This trial is active, not recruiting.

Conditions healthy canadians, appetite control
Treatment snack
Sponsor St. Boniface General Hospital Research Centre
Collaborator Manitoba Agri-Health Research Network
Start date June 2013
End date August 2014
Trial size 38 participants
Trial identifier NCT01806688, H2013:036, RRC/2013/1276

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking single blind (subject)
Arm
(Experimental)
gluten-free high protein snack
snack gluten-free mid-morning snack
(Experimental)
gluten-free high protein and high fibre snack
snack gluten-free mid-morning snack
(Placebo Comparator)
gluten-free snack with similar energy density, but 1/2 the protein as snack #1
snack gluten-free mid-morning snack
(Placebo Comparator)
gluten-free snack with similar energy density, but less protein and fibre than snack #2
snack gluten-free mid-morning snack
(Placebo Comparator)
water
snack gluten-free mid-morning snack
(Placebo Comparator)
water
snack gluten-free mid-morning snack

Primary Outcomes

Measure
total area under the curve for hunger, fullness, desire to eat and prospective consumption visual analog scales
time frame: 3 hours

Secondary Outcomes

Measure
number of calories consumed post-snack until bedtime
time frame: time between snack consumption and bedtime

Eligibility Criteria

Male or female participants from 20 years up to 70 years old.

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.

Additional Information

Official title A Randomized, Controlled, Cross-over Study of the Effect of Snacks on Appetite Control
Principal investigator Heather J Blewett, PhD
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by St. Boniface General Hospital Research Centre.