Developing Methods for Completing Future Satiety Studies

Lack of Satiety Clinical Trial

Official title:

Developing and Validating a Method for Satiety Studies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01379911
• Other study ID #: 11AP036
• Status: Completed
• Phase: N/A
• First received: June 15, 2011
• Last updated: January 20, 2016
• Start date: February 2013
• Est. completion date: October 2015

Study information

• Verified date: January 2016
• Source: University of Guelph
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

Satiety is defined as the inhibition of eating, as a consequence of fullness after consuming food. Being able to effectively measure satiety is an important concept that has implications in the treatment and prevention of overweight and obesity. Increasing post-meal satiety is recognized a useful strategy for weight management. Recently, the category of foods marketed as having satiating effects has seen significant growth and this trend is expected to continue. The purpose of this project is to develop and validate methods for assessing the degree of satiety induced by foods and natural health products using commercially available food products.

This trial will examine the effects of a commercially available yogurt (containing added protein and fibre) on self-reported satiety and hunger, as well as food intake in both controlled and uncontrolled settings.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 35 Years

Eligibility

Inclusion Criteria:

• Healthy women with regular hormonal contraceptive use, aged between 20 and 35 years

• BMI of 20.0-24.9 kg/m2

• Regular yogurt consumers (i.e. > 3 servings per week)

Exclusion Criteria:

• Taking any regular medications or herbal supplements other than a multivitamin or folic acid supplement.

• History of cardiovascular disease (including hypertension), diabetes, hypoglycemia, gum disease or any other medical condition

• Vegans or vegetarians who exclude dairy products

• Milk allergies or any other food allergies

• Anyone with known anaphylactic allergic reactions, food or otherwise

• Dislike or unwillingness to consume study foods

• Gastrointestinal disease or disorders, including Celiac disease, lactose intolerance, irritable bowel syndrome, etc.

• BMI <20.0 or > 25.0 kg/m2

• Current participation in diet/weight-loss programs and/or changes of > 5 kg body weight within the past 6 months

• Unusual dietary patterns (i.e. routinely skipping breakfast or other meals)

• Unusual sleep patterns (i.e. shift workers)

• High habitual intake of caffeinated beverages or alcohol

• Restrained or disinhibited eaters, defined by the Three Factor Eating Questionnaire

• Smokers

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Lack of Satiety

Intervention

Other:
• Yogurt

Locations

Country	Name	City	State
Canada	Human Nutraceutical Research Unit, University of Guelph	Guelph	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University of Guelph

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self-reported ratings of satiety	The study consists of two trial days (pre- and post home consumption) per study period, one for each of 2 yogurts. Each study visit involves a 4-hour stay at the HNRU. The pre-study visit will be followed by a 6-day yogurt self-administration period where participants will consume the assigned yogurt at breakfast. Thus, the acute satiety effects of the yogurts will be replicated in a controlled (laboratory) setting and evaluated over a 6-day period in an uncontrolled (home/lifestyle) environment.	Outcome measures will be assessed at fasting (0 min) and postprandially (every 30 min) for 3 hours.	No
Secondary	Food intake	Study will include food and caloric intake over entire study day and for 6 days subsequent to initial study visit.	One week	No