Developing Methods for Completing Future Satiety Studies

Developing and Validating a Method for 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.

Study Overview

• Status: Completed
• Conditions: Lack of Satiety
• Intervention / Treatment: Other: Yogurt

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Guelph, Ontario, Canada, N1G2W1
      • Human Nutraceutical Research Unit, University of Guelph

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Yogurt with added inulin; Yogurt with 6g of added inulin	Other: Yogurt
Placebo Comparator: Regular yogurt; Regular yogurt without added inulin	Other: Yogurt

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Food intake	Study will include food and caloric intake over entire study day and for 6 days subsequent to initial study visit.	One week

Collaborators and Investigators

• Sponsor: University of Guelph
• Investigators: Principal Investigator: Amanda J Wright, Ph.D., University of Guelph

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: June 15, 2011
• First Submitted That Met QC Criteria: June 21, 2011
• First Posted (Estimate): June 23, 2011

Study Record Updates

• Last Update Posted (Estimate): January 21, 2016
• Last Update Submitted That Met QC Criteria: January 20, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: Satiety; Food intake; Yogurt
• Other Study ID Numbers: 11AP036