Effect of Certain Breakfasts on Appetite Control

Appetite Clinical Trial

Official title:

A Randomized, Controlled, Cross-over Study of the Effect of Certain Breakfasts on Appetite Control.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02111486
• Other study ID #: B2014:027
• Status: Withdrawn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• Status: Withdrawn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

• Appetite
• Post-prandial Glucose Response

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