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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT02111486
Other study ID # B2014:027
Secondary ID
Status Withdrawn
Phase N/A
First received April 9, 2014
Last updated October 17, 2016
Start date October 2015
Est. completion date October 2015

Study information

Verified date October 2016
Source St. Boniface General Hospital Research Centre
Contact n/a
Is FDA regulated No
Health authority Canada: Ethics Review Committee
Study type Interventional

Clinical Trial 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.


Description:

The study is divided into 3 phases. Each phase involves eating one of 3 different breakfasts every day for 1 month. The order of the breakfast products is random. During each phase participants will come to the research clinic for 4 visits (1 per week) for assessment of appetite-related sensations. Gastric emptying will be assessed at 1 visit per phase and post prandial glucose response will be measured at 1 visit per phase (Asper site only).


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date October 2015
Est. primary completion date October 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 19 Years to 60 Years
Eligibility Inclusion Criteria:

1. Healthy Males and females (not pregnant or lactating) aged 19 to 60 years.

2. Body mass index: 18.5-30 kg/m2.

Exclusion Criteria:

1. A change in medication (dose or type) or medical event requiring hospitalization within the past month.

2. Daily tobacco use.

3. Physical Activity Level >1.8.

4. Eat meals at irregular or unusual times.

5. Food allergy, aversion or unwillingness to eat study foods.

6. Use of any prescription or non-prescription drug, herbal or nutritional supplement known to affect appetite or blood sugar.

7. Presence of a gastrointestinal disorder.

8. Taking drugs that affect gastric emptying.

9. Score >65% on any 1 of the 3 categories of the Three Factor Eating Questionnaire-R18.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Other:
breakfast


Locations

Country Name City State
Canada I.H. Asper Clinical Research Institute Winnipeg Manitoba
Canada Richardson Centre for Functional Foods and Nutraceuticals Winnipeg Manitoba

Sponsors (2)

Lead Sponsor Collaborator
St. Boniface General Hospital Research Centre Agriculture and Agri-Food Canada

Country where clinical trial is conducted

Canada, 

References & 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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Gastrointestinal side effects Incidence and duration of gastrointestinal side effects. 4 weeks Yes
Primary 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 No
Primary 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 No
Secondary Glucose and Insulin Total area under the curve (iAUC, mmol*min/L) for both glucose and insulin before the breakfast and at 15, 30, 45, 60, 90 and 120 minutes after the the breakfast. No
Secondary Kilocalories Measure the amount of kilocalories consumed throughout each test day. 1 day No
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