Developing Methods for Completing Future Satiety Studies

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.

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Key information

Conditions

Lack of Satiety

Age range

20 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Human Nutraceutical Research Unit, University of Guelph

Guelph, Ontario, N1G2W1, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Yogurt

Other

Primary outcomes

Self-reported ratings of satiety

Time frame: Outcome measures will be assessed at fasting (0 min) and postprandially (every 30 min) for 3 hours.

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.

Secondary outcomes

Food intake

Time frame: One week

Study will include food and caloric intake over entire study day and for 6 days subsequent to initial study visit.

Sponsors and collaborators

Lead sponsor

University of Guelph

Other

Registry information

Official study title

Developing and Validating a Method for Satiety Studies

Important dates

Study start: 2013
Primary completion: 2015
Study completion: 2015
First posted: Jun 23, 2011
Registry last updated: Jan 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed