Effect of Snacks on Appetite Control

Study Overview
=================
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.

Official Title
-----------------
A Randomized, Controlled, Cross-over Study of the Effect of Snacks on Appetite Control

Conditions
-----------------
Healthy Canadians, Appetite Control

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


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Randomized crossover
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Snack #1<br>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. | Other: gluten-free high protein snack #1<br>* buckwheat groats 30g serving<br>Other: gluten-free snack with similar energy density but 1/2 the protein as snack #1<br>* 32g serving of corn nuts<br>Other: non-caloric control<br>* water<br>|
| Experimental: Experimental Snack #2<br>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. | Other: non-caloric control<br>* water<br>Other: gluten-free high protein and high fibre snack #2<br>* buckwheat and pinto bean flour pita bread 50g serving<br>Other: gluten-free snack with similar energy density, but less protein and fibre than snack #2<br>* 50g serving of rice bread<br>|

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) | 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 | 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) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
satiety, appetite, snack