Developing Methods for Completing Future Satiety Studies

NCT ID: NCT01379911

Last Updated: 2016-01-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2015-10-31

Brief 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.

Conditions

Lack of Satiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Yogurt with added inulin

Yogurt with 6g of added inulin

Group Type: ACTIVE_COMPARATOR

Yogurt

Intervention Type: OTHER

Regular yogurt

Regular yogurt without added inulin

Group Type: PLACEBO_COMPARATOR

Yogurt

Intervention Type: OTHER

Interventions

Yogurt

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Guelph

OTHER

Sponsor Role: lead

Responsible Party

Amy Tucker

Manager, HNRU

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amanda J Wright, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Guelph

Locations

Human Nutraceutical Research Unit, University of Guelph

Guelph, Ontario, Canada

Countries

Canada

Other Identifiers

11AP036

Identifier Type: -

Identifier Source: org_study_id