NCT02111486

Brief Summary

This clinical trial is being conducted to study whether eating certain meals will reduce your desire to eat and for a longer period of time compared to others and to determine the post-meal glucose response associated with each of these breakfast foods.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2015

Geographic Reach
1 country

2 active sites

Status
withdrawn

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

April 9, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 11, 2014

Completed
1.5 years until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

October 18, 2016

Status Verified

October 1, 2016

Enrollment Period

Same day

First QC Date

April 9, 2014

Last Update Submit

October 17, 2016

Conditions

AppetitePost-prandial Glucose Response

Keywords

BreakfastSatietyFibreGlucoseGastric emptying

Outcome Measures

Primary Outcomes (2)

  • Satiety

    Total area under the curve (AUC) for hunger, fullness, desire to eat, and prospective consumption scales

    before the breakfast and every 30 minutes after breakfast for 4 hours

  • Gastric emptying rate

    13C-Octanoic Acid will be incorporated into the breakfast food. Rate of gastric emptying will be determined by measuring 13C in breath samples.

    before the breakfast and every 15 minutes after breakfast for 4 hours

Secondary Outcomes (2)

  • Glucose and Insulin

    before the breakfast and at 15, 30, 45, 60, 90 and 120 minutes after the the breakfast.

  • Kilocalories

    1 day

Other Outcomes (1)

  • Gastrointestinal side effects

    4 weeks

Study Arms (3)

breakfast #1

EXPERIMENTAL

breakfast food containing high viscosity fibre

Other: breakfast

breakfast #2

EXPERIMENTAL

breakfast food containing low viscosity fibre

Other: breakfast

Control

PLACEBO COMPARATOR

breakfast food without viscous fibre

Other: breakfast

Interventions

breakfastOTHER
Controlbreakfast #1breakfast #2

Eligibility Criteria

Age19 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy Males and females (not pregnant or lactating) aged 19 to 60 years.
  • Body mass index: 18.5-30 kg/m2.

You may not qualify if:

  • A change in medication (dose or type) or medical event requiring hospitalization within the past month.
  • 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 or blood sugar.
  • Presence of a gastrointestinal disorder.
  • Taking drugs that affect gastric emptying.
  • 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 (2)

I.H. Asper Clinical Research Institute

Winnipeg, Manitoba, R2H 2A6, Canada

Location

Richardson Centre for Functional Foods and Nutraceuticals

Winnipeg, Manitoba, R3T 2N2, Canada

Location

Related Publications (5)

  • Beck EJ, Tosh SM, Batterham MJ, Tapsell LC, Huang XF. Oat beta-glucan increases postprandial cholecystokinin levels, decreases insulin response and extends subjective satiety in overweight subjects. Mol Nutr Food Res. 2009 Oct;53(10):1343-51. doi: 10.1002/mnfr.200800343.

    PMID: 19753601BACKGROUND

  • 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

  • Pentikainen S, Karhunen L, Flander L, Katina K, Meynier A, Aymard P, Vinoy S, Poutanen K. Enrichment of biscuits and juice with oat beta-glucan enhances postprandial satiety. Appetite. 2014 Apr;75:150-6. doi: 10.1016/j.appet.2014.01.002. Epub 2014 Jan 14.

    PMID: 24434584BACKGROUND

  • Thondre PS, Henry CJ. High-molecular-weight barley beta-glucan in chapatis (unleavened Indian flatbread) lowers glycemic index. Nutr Res. 2009 Jul;29(7):480-6. doi: 10.1016/j.nutres.2009.07.003.

    PMID: 19700035BACKGROUND

  • de Graaf C, Blom WA, Smeets PA, Stafleu A, Hendriks HF. Biomarkers of satiation and satiety. Am J Clin Nutr. 2004 Jun;79(6):946-61. doi: 10.1093/ajcn/79.6.946.

    PMID: 15159223BACKGROUND

MeSH Terms

Interventions

Breakfast

Intervention Hierarchy (Ancestors)

MealsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Heather Blewett, Ph.D

    I.H. Asper Clinical Research Institute/Agriculture and Agri-Food Canada

    PRINCIPAL INVESTIGATOR

  • Nancy Ames, PhD

    Richardson Centre for Functional Foods and Nutraceuticals/Agriculture and Agri-Food Canada

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 9, 2014

First Posted

April 11, 2014

Study Start

October 1, 2015

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

October 18, 2016

Record last verified: 2016-10

Locations

CA(2)