NCT01806688

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 5, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 7, 2013

Completed
4 months until next milestone

Study Start

First participant enrolled

July 6, 2013

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 23, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 23, 2014

Completed
7 years until next milestone

Results Posted

Study results publicly available

August 12, 2021

Completed
Last Updated

August 12, 2021

Status Verified

August 1, 2021

Enrollment Period

1.1 years

First QC Date

March 5, 2013

Results QC Date

November 6, 2019

Last Update Submit

August 11, 2021

Conditions

Keywords

satietyappetitesnack

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • Number of Calories Consumed Post-snack Until Bedtime

    time between snack consumption and bedtime (12 hours)

Other Outcomes (2)

  • Gastrointestinal Side Effects

    24h

  • Likeability of Test and Reference Products Based on Sensory Scales

    immediately after eating test or reference product

Study Arms (2)

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 #1Other: gluten-free snack with similar energy density but 1/2 the protein as snack #1Other: 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 controlOther: gluten-free high protein and high fibre snack #2Other: gluten-free snack with similar energy density, but less protein and fibre than snack #2

Interventions

buckwheat groats 30g serving

Experimental Snack #1

water

Experimental Snack #1Experimental Snack #2

buckwheat and pinto bean flour pita bread 50g serving

Experimental Snack #2

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Body mass index 18-30kg/m2
  • males and non-pregnant or non-lactating females

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

I. H. Asper Clinical Research Institute

Winnipeg, Manitoba, R2H 2A6, Canada

Location

Related Publications (3)

  • 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.

    PMID: 20122136BACKGROUND
  • 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.

    PMID: 18469287BACKGROUND
  • 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.

    PMID: 22909980BACKGROUND

Related Links

Results Point of Contact

Title
Dr. Heather Blewett
Organization
Agriculture and Agri-Food Canada

Study Officials

  • Heather J Blewett, PhD

    St. Boniface Hospital Research Centre

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: Randomized crossover
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 5, 2013

First Posted

March 7, 2013

Study Start

July 6, 2013

Primary Completion

August 23, 2014

Study Completion

August 23, 2014

Last Updated

August 12, 2021

Results First Posted

August 12, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Group results will be emailed or mailed to individuals upon request once they are available.

Locations