Developing Methods for Completing Future Satiety Studies

Overview

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.

Full Title of Study: “Developing and Validating a Method for Satiety Studies”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Basic Science
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: October 2015

Interventions

  • Other: Yogurt

Arms, Groups and Cohorts

  • Active Comparator: Yogurt with added inulin
    • Yogurt with 6g of added inulin
  • Placebo Comparator: Regular yogurt
    • Regular yogurt without added inulin

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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.

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 20 Years

Maximum Age: 35 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of Guelph
  • Provider of Information About this Clinical Study
    • Principal Investigator: Amy Tucker, Manager, HNRU – University of Guelph
  • Overall Official(s)
    • Amanda J Wright, Ph.D., Principal Investigator, University of Guelph

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