Trial Outcomes & Findings for Effect of Snacks on Appetite Control (NCT NCT01806688)

Last Updated: 2021-08-12

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

46 participants

Primary outcome 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.

Results posted on

2021-08-12

Participant Flow

289 candidates were screened between June 2013 and August 2014. Of these 289 candidates, 50 met the criteria and were determined to be eligible. The first participant was enrolled on July 6, 2013 and the last participant enrolled August 9, 2014. 46 participants were enrolled in the overall study and 30 of these completed both the seed study and the pita study while 16 participated in only one of the studies. 38 participants were randomized to the seed study and 38 to the pita study.

30 people completed both studies and 16 participated in only 1 study.

Participant milestones

Participant milestones
Measure	Seed Study 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.	Pita Study 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.
First Intervention Seed Study STARTED	38	0
First Intervention Seed Study Experimental Snack #1	13	0
First Intervention Seed Study Placebo Comparator Reference Product #1	13	0
First Intervention Seed Study Placebo Comparator Non-caloric Control #1	12	0
First Intervention Seed Study COMPLETED	38	0
First Intervention Seed Study NOT COMPLETED	0	0
Second Intervention Seed Study STARTED	38	0
Second Intervention Seed Study Experimental Snack #1	13	0
Second Intervention Seed Study Placebo Comparator Reference Product #1	13	0
Second Intervention Seed Study Placebo Comparator Non-caloric Control #1	12	0
Second Intervention Seed Study COMPLETED	38	0
Second Intervention Seed Study NOT COMPLETED	0	0
Third Intervention Seed Study STARTED	38	0
Third Intervention Seed Study Experimental Snack #1	12	0
Third Intervention Seed Study Placebo Comparator Reference Product #1	12	0
Third Intervention Seed Study Placebo Comparator Non-caloric Control #1	14	0
Third Intervention Seed Study COMPLETED	38	0
Third Intervention Seed Study NOT COMPLETED	0	0
First Intervention Pita Study STARTED	0	38
First Intervention Pita Study Experimental Snack #2	0	14
First Intervention Pita Study Placebo Comparator Reference Product #2	0	12
First Intervention Pita Study Placebo Comparator Non-caloric Control #2	0	12
First Intervention Pita Study COMPLETED	0	38
First Intervention Pita Study NOT COMPLETED	0	0
Second Intervention Pita Study STARTED	0	38
Second Intervention Pita Study Experimental Snack #2	0	12
Second Intervention Pita Study Placebo Comparator Reference Product #2	0	13
Second Intervention Pita Study Placebo Comparator Non-caloric Control #2	0	13
Second Intervention Pita Study COMPLETED	0	38
Second Intervention Pita Study NOT COMPLETED	0	0
Third Intervention Pita Study STARTED	0	38
Third Intervention Pita Study Experimental Snack #2	0	12
Third Intervention Pita Study Placebo Comparator Reference Product #2	0	13
Third Intervention Pita Study Placebo Comparator Non-caloric Control #2	0	13
Third Intervention Pita Study COMPLETED	0	38
Third Intervention Pita Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

289 candidates were screened for the study between June 2013 and August 2014. Of those 289 candidates, 50 met the inclusion criteria and of those 50, a total of 46 were enrolled in the overall study. 38 were randomized to treatment in the Seed Study and 38 were randomized to treatment in the Pita Study. 30 completed both studies and 16 chose to do just one study.

Baseline characteristics by cohort

PRIMARY outcome

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.

Population: A total of 46 participants were enrolled in the Seed and the Pita Study. Of these 46, 30 participated in both studies and 16 enrolled in just one study. 38 participants enrolled in the Seed Study and 38 in the Pita Study.

Outcome measures

Outcome measures
Measure	Seed Study n=37 Participants 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.	Pita Study n=37 Participants 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 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 fiber than snack #2, comprised of a 50g serving of rice bread. The placebo comparator non-caloric control is water.
Total Area Under the Curve (AUC) for Hunger, Fullness, Desire to Eat and Prospective Consumption Using Visual Analog Scales (VAS) Seed Study Experimental Snack #1 Hunger	651 cm x min Standard Error 46	—
Total Area Under the Curve (AUC) for Hunger, Fullness, Desire to Eat and Prospective Consumption Using Visual Analog Scales (VAS) Seed Study Experimental Snack #1 Fullness	1008 cm x min Standard Error 46	—
Total Area Under the Curve (AUC) for Hunger, Fullness, Desire to Eat and Prospective Consumption Using Visual Analog Scales (VAS) Seed Study Experimental Snack #1 Desire	638 cm x min Standard Error 46	—
Total Area Under the Curve (AUC) for Hunger, Fullness, Desire to Eat and Prospective Consumption Using Visual Analog Scales (VAS) Seed Study Experimental Snack #1 Consume	640 cm x min Standard Error 42	—
Total Area Under the Curve (AUC) for Hunger, Fullness, Desire to Eat and Prospective Consumption Using Visual Analog Scales (VAS) Seed Study Placebo Comparator #1 Hunger	636 cm x min Standard Error 46	—
Total Area Under the Curve (AUC) for Hunger, Fullness, Desire to Eat and Prospective Consumption Using Visual Analog Scales (VAS) Seed Study Placebo Comparator #1 Fullness	1024 cm x min Standard Error 46	—
Total Area Under the Curve (AUC) for Hunger, Fullness, Desire to Eat and Prospective Consumption Using Visual Analog Scales (VAS) Seed Study Placebo Comparator #1 Desire	659 cm x min Standard Error 46	—
Total Area Under the Curve (AUC) for Hunger, Fullness, Desire to Eat and Prospective Consumption Using Visual Analog Scales (VAS) Seed Study Placebo Comparator #1 Consume	649 cm x min Standard Error 42	—
Total Area Under the Curve (AUC) for Hunger, Fullness, Desire to Eat and Prospective Consumption Using Visual Analog Scales (VAS) Seed Study Placebo Comparator #1 Non-caloric Control Hunger	962 cm x min Standard Error 46	—
Total Area Under the Curve (AUC) for Hunger, Fullness, Desire to Eat and Prospective Consumption Using Visual Analog Scales (VAS) Seed Study Placebo Control #1 Non-caloric Control Fullness	682 cm x min Standard Error 47	—
Total Area Under the Curve (AUC) for Hunger, Fullness, Desire to Eat and Prospective Consumption Using Visual Analog Scales (VAS) Seed Study Placebo Control #1 Non-caloric Control Desire	980 cm x min Standard Error 47	—
Total Area Under the Curve (AUC) for Hunger, Fullness, Desire to Eat and Prospective Consumption Using Visual Analog Scales (VAS) Seed Study Placebo Comparator Non-caloric Control #1 Consume	916 cm x min Standard Error 42	—
Total Area Under the Curve (AUC) for Hunger, Fullness, Desire to Eat and Prospective Consumption Using Visual Analog Scales (VAS) Pita Study Experimental Snack #2 Hunger	—	611 cm x min Standard Error 40
Total Area Under the Curve (AUC) for Hunger, Fullness, Desire to Eat and Prospective Consumption Using Visual Analog Scales (VAS) Pita Study Experimental Snack #2 Fullness	—	1005 cm x min Standard Error 41
Total Area Under the Curve (AUC) for Hunger, Fullness, Desire to Eat and Prospective Consumption Using Visual Analog Scales (VAS) Pita Study Experimental Snack #2 Desire	—	616 cm x min Standard Error 44
Total Area Under the Curve (AUC) for Hunger, Fullness, Desire to Eat and Prospective Consumption Using Visual Analog Scales (VAS) Pita Study Experimental Snack #2 Consume	—	599 cm x min Standard Error 38
Total Area Under the Curve (AUC) for Hunger, Fullness, Desire to Eat and Prospective Consumption Using Visual Analog Scales (VAS) Pita Study Placebo Comparator #2 Reference Product Hunger	—	661 cm x min Standard Error 39
Total Area Under the Curve (AUC) for Hunger, Fullness, Desire to Eat and Prospective Consumption Using Visual Analog Scales (VAS) Pita Study Placebo Comparator #2 Reference Product Fullness	—	968 cm x min Standard Error 40
Total Area Under the Curve (AUC) for Hunger, Fullness, Desire to Eat and Prospective Consumption Using Visual Analog Scales (VAS) Pita Study Placebo Comparator #2 Reference Product Desire	—	682 cm x min Standard Error 43
Total Area Under the Curve (AUC) for Hunger, Fullness, Desire to Eat and Prospective Consumption Using Visual Analog Scales (VAS) Pita Study Placebo Comparator #2 Reference Product Consume	—	676 cm x min Standard Error 38
Total Area Under the Curve (AUC) for Hunger, Fullness, Desire to Eat and Prospective Consumption Using Visual Analog Scales (VAS) Pita Study Placebo Comparator #2 Non-caloric Control Hunger	—	956 cm x min Standard Error 39
Total Area Under the Curve (AUC) for Hunger, Fullness, Desire to Eat and Prospective Consumption Using Visual Analog Scales (VAS) Pita Study Placebo Comparator #2 Non-caloric Control Fullness	—	675 cm x min Standard Error 40
Total Area Under the Curve (AUC) for Hunger, Fullness, Desire to Eat and Prospective Consumption Using Visual Analog Scales (VAS) Pita Study Placebo Comparator #2 Non-caloric Control Desire	—	1001 cm x min Standard Error 43
Total Area Under the Curve (AUC) for Hunger, Fullness, Desire to Eat and Prospective Consumption Using Visual Analog Scales (VAS) Pita Study Placebo Comparator #2 Non-caloric Control Consume	—	959 cm x min Standard Error 38

SECONDARY outcome

Timeframe: time between snack consumption and bedtime (12 hours)

Population: In the Seed Study data for 36 participants was analyzed. One participant was not analyzed due to non compliance and a second participant for not providing a food record. In the Pita Study data from 34 participants was analyzed. One participant was noncompliant and 3 did not turn in food records.

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.

Outcome measures

Outcome measures
Measure	Seed Study n=36 Participants 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.	Pita Study n=34 Participants 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 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 fiber than snack #2, comprised of a 50g serving of rice bread. The placebo comparator non-caloric control is water.
Number of Calories Consumed Post-snack Until Bedtime Seed Study Experimental Snack #1	1429 kcal Standard Error 70	—
Number of Calories Consumed Post-snack Until Bedtime Seed Study Placebo Comparator #1 Reference Product	1326 kcal Standard Error 94	—
Number of Calories Consumed Post-snack Until Bedtime Seed Study Placebo Comparator #1 Non-caloric Control	1288 kcal Standard Error 80	—
Number of Calories Consumed Post-snack Until Bedtime Pita Study Experimental Snack #2	—	1448 kcal Standard Error 89
Number of Calories Consumed Post-snack Until Bedtime Pita Study Placebo Comparator #2 Reference Product	—	1414 kcal Standard Error 78
Number of Calories Consumed Post-snack Until Bedtime Pita Study Placebo Comparator #2 Non-caloric Control	—	1478 kcal Standard Error 75

OTHER_PRE_SPECIFIED outcome

Timeframe: 24h

Participants were asked if they noticed any gastrointestinal side effects after having eaten the study food and the results were recorded.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Seed Study n=38 Participants 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.	Pita Study n=38 Participants 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 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 fiber than snack #2, comprised of a 50g serving of rice bread. The placebo comparator non-caloric control is water.
Likeability of Test and Reference Products Based on Sensory Scales Experimental Snack taste	3.57 sensory rating on a scale of 1 to 5 Standard Error .2	3.66 sensory rating on a scale of 1 to 5 Standard Error .15
Likeability of Test and Reference Products Based on Sensory Scales Experimental Snack texture	3.66 sensory rating on a scale of 1 to 5 Standard Error .19	3.49 sensory rating on a scale of 1 to 5 Standard Error .19
Likeability of Test and Reference Products Based on Sensory Scales Experimental Snack appearance	3.57 sensory rating on a scale of 1 to 5 Standard Error .16	3.81 sensory rating on a scale of 1 to 5 Standard Error .14
Likeability of Test and Reference Products Based on Sensory Scales Experimental Snack overall	3.48 sensory rating on a scale of 1 to 5 Standard Error .18	3.64 sensory rating on a scale of 1 to 5 Standard Error .15
Likeability of Test and Reference Products Based on Sensory Scales Experimental Snack aroma	3.4 sensory rating on a scale of 1 to 5 Standard Error .11	3.45 sensory rating on a scale of 1 to 5 Standard Error .10
Likeability of Test and Reference Products Based on Sensory Scales Placebo Comparator Reference taste	3.23 sensory rating on a scale of 1 to 5 Standard Error .20	3.67 sensory rating on a scale of 1 to 5 Standard Error .15
Likeability of Test and Reference Products Based on Sensory Scales Placebo Comparator Reference texture	2.64 sensory rating on a scale of 1 to 5 Standard Error .19	3.36 sensory rating on a scale of 1 to 5 Standard Error .19
Likeability of Test and Reference Products Based on Sensory Scales Placebo Comparator Reference appearance	3.49 sensory rating on a scale of 1 to 5 Standard Error .16	3.74 sensory rating on a scale of 1 to 5 Standard Error .14
Likeability of Test and Reference Products Based on Sensory Scales Placebo Comparator Reference aroma	3.34 sensory rating on a scale of 1 to 5 Standard Error .11	3.39 sensory rating on a scale of 1 to 5 Standard Error .10
Likeability of Test and Reference Products Based on Sensory Scales Placebo Comparator Reference overall	3.05 sensory rating on a scale of 1 to 5 Standard Error .18	3.58 sensory rating on a scale of 1 to 5 Standard Error .14

Adverse Events

Seed Study

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Pita Study

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Heather Blewett

Agriculture and Agri-Food Canada

Phone: 204 237-2954

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place