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Developing Methods for Completing Future Satiety Studies

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ClinicalTrials.gov Identifier: NCT01379911
Recruitment Status : Completed
First Posted : June 23, 2011
Last Update Posted : January 21, 2016
Sponsor:
Information provided by (Responsible Party):
Amy Tucker, University of Guelph

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.


Condition or disease Intervention/treatment Phase
Lack of Satiety Other: Yogurt Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Developing and Validating a Method for Satiety Studies
Study Start Date : February 2013
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

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



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.



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Ages Eligible for Study:   20 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01379911


Locations
Canada, Ontario
Human Nutraceutical Research Unit, University of Guelph
Guelph, Ontario, Canada, N1G2W1
Sponsors and Collaborators
University of Guelph
Investigators
Principal Investigator: Amanda J Wright, Ph.D. University of Guelph

Responsible Party: Amy Tucker, Manager, HNRU, University of Guelph
ClinicalTrials.gov Identifier: NCT01379911     History of Changes
Other Study ID Numbers: 11AP036
First Posted: June 23, 2011    Key Record Dates
Last Update Posted: January 21, 2016
Last Verified: January 2016

Keywords provided by Amy Tucker, University of Guelph:
Satiety
Food intake
Yogurt