Innovation of Breakfast Cereals and Snacks for Control of Appetite and Post-Prandial Glycemia

Obesity Clinical Trial

Official title:

Innovation of Breakfast Cereals and Snacks for Control of Appetite and Post-Prandial Glycemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02465021
• Other study ID #: 30422
• Status: Completed
• Phase: N/A
• First received: June 3, 2015
• Last updated: September 25, 2017
• Start date: March 2015
• Est. completion date: October 2015

Study information

• Verified date: September 2017
• Source: University of Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of the proposed research is to investigate the effects of novel snack products differing in macronutrient composition, fibre and sugar content on post-prandial glycemia and short-term appetite control in healthy adults.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Healthy, non-smoking individuals aged 18-55 years with a body mass index of 20.0-29.9 kg/m2

Exclusion Criteria:

• Smokers, individuals with diabetes or other cardiometabolic diseases, persons who suffer from gastrointestinal disorders or have had gastric surgery, or people who regularly use bulk laxatives

• Women with irregular menstruation or who use hormonal contraceptives or hormone replacement therapy

• Individuals who regularly skip breakfast, have allergies to any of the test food ingredients, or who follow a restrictive diet

Related Conditions & MeSH terms

• Diabetes
• Obesity

Intervention

Other:
• Dietary intervention
All arms are given to all participants, in a randomized order

Locations

Country	Name	City	State
Canada	Department of Nutritional Sciences, University of Toronto	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University of Toronto	General Mills Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Food Recall	Participants are asked to complete a 24-hour Food Recall starting at dinner the night before each study session and ending at dinner the day of that session.	24 hours
Primary	Food intake	Food intake (kCal) is assessed 120 min after consumption of the treatments, using an ad libitum pizza lunch design. Participants are asked to eat, during a 20-min period, until feeling comfortably full	120 minutes
Secondary	Perceived satiety	Satiety scores (mm) are assessed using 100-mm "Motivation to Eat" visual analog scale questionnaires. A composite score of the four appetite questions, including Desire to Eat, Hunger, Fullness and Prospective Food Consumption, in the "Motivation to Eat" visual analog scale is calculated to obtain the average appetite score for statistical analysis	120 minutes
Secondary	Blood glucose	Blood glucose (mmol/L) is measured using finger prick capillary blood samples	0 to 120 min (pre-ad libitum lunch) and 140 to 260 min (post-ad libitum lunch) after consumption of treatments
Secondary	Blood insulin	Blood insulin (µU/mL) is measured using finger prick capillary blood samples	0 to 120 min (pre-ad libitum lunch) and 140 to 260 min (post-ad libitum lunch) after consumption of treatments