Effect of Snacks on Appetite Control | NCT01806688

ID	Type	Description	Link
RRC/2013/1276	Other Identifier	Research Review Committee

Name	Class
Manitoba Agri-Health Research Network	OTHER

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Experimental Snack #1	Experimental	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 Other: gluten-free snack with similar energy density but 1/2 the protein as snack #1 Other: non-caloric control
Experimental Snack #2	Experimental	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 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

Name	Type	Description	Arm Group Labels	Other Names
gluten-free high protein snack #1	Other	buckwheat groats 30g serving	Experimental Snack #1

Outcomes Module

Primary Outcomes

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 Outcomes

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)

Other Outcomes

Measure	Description	Time Frame
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
Likeability of Test and Reference Products Based on Sensory Scales

Name	Affiliation	Role
Heather J Blewett, PhD	St. Boniface Hospital Research Centre	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
I. H. Asper Clinical Research Institute		Winnipeg	Manitoba	R2H 2A6	Canada

PubMed Identifier	Type	Citation	Retractions
20122136	Background	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.
18469287	Background

Label	URL
Obesity in Canada: A joint report from the Public Health Agency of Canada and the Canadian Institute for Health Information	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	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.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

ID	Title	Description
BG000	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.
BG001	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 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.
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG00038 BG00138 BG00276

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Categorical

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.

Count of Participants

Participants

Title

Denominators

Categories

Seed Study

- ParticipantsBG00038
- ParticipantsBG0010
- ParticipantsBG00238

Title	Measurements
<=18 years

Age, Continuous

A total of 46 participants were enrolled in the overall study, and of those 46 enrolled, 30 participated in both studies while 16 only participated in one study. 38 participants were randomized to complete the Seed Study and 38 participants to complete the Pita Study.

Mean

Full Range

years

Title	Denominators	Categories
Seed Study	ParticipantsBG00038 ParticipantsBG0010 ParticipantsBG002

Sex: Female, Male

Count of Participants

Participants

Title	Denominators	Categories
Seed Study	ParticipantsBG00038 ParticipantsBG0010 ParticipantsBG002

Race (NIH/OMB)

Count of Participants

Participants

Title	Denominators	Categories
Seed Study	ParticipantsBG00038 ParticipantsBG0010 ParticipantsBG002

Region of Enrollment

Seed Study

Data collected from the two studies are reported in separate Baseline Measures

Count of Participants

Participants

Title	Denominators	Categories
Canada	ParticipantsBG00038 ParticipantsBG0010 ParticipantsBG002

Region of Enrollment

Pita Study

Data collected from the two studies are reported in separate Baseline Measures

Count of Participants

Participants

Title	Denominators	Categories
Canada	ParticipantsBG0000 ParticipantsBG00138 ParticipantsBG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

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.

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.

Posted

Least Squares Mean

Standard Error

cm x min

VAS administered pre-snack and then every 30 minutes after the first bite up to 180 minutes for a total of 7 time points.

ID	Title	Description
OG000	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.
OG001	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 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.

Units	Counts
Participants	OG00037 OG00137

Title

Denominators

Categories

Seed Study Experimental Snack #1 Hunger

- ParticipantsOG00037
- ParticipantsOG0010

Title	Measurements
	OG000651± 46

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Items #1 were compared to each other and Items #2 were compared to each other	ANCOVA	Sources of variation included in the model: snack, visit number, baseline score, visit number × snack, and snack × overweight.	<0.05														Equivalence	The study is designed to detect a 10.0% difference in area under the curve (AUC) appetite ratings between foods. The required number of Participants is 38.

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.

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.

Posted

Mean

Standard Error

kcal

time between snack consumption and bedtime (12 hours)

ID	Title	Description
OG000	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.
OG001	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 buckwheat pita. 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 Pre-specified

Gastrointestinal Side Effects

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

Not Posted

24h

Participants

Other Pre-specified

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.

Posted

Least Squares Mean

Standard Error

sensory rating on a scale of 1 to 5

immediately after eating test or reference product

ID	Title	Description
OG000	Experimental Snack #1	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.
OG001	Experimental Snack #2	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 fibre than snack #2, comprised of a 50g serving of rice bread. The placebo comparator non-caloric control is water.

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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.	0	38	0	38	0	38
EG001	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.	0	38	0	38	0	38