NCT01379911

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 15, 2011

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 23, 2011

Completed
1.6 years until next milestone

Study Start

First participant enrolled

February 1, 2013

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

January 21, 2016

Status Verified

January 1, 2016

Enrollment Period

2.7 years

First QC Date

June 15, 2011

Last Update Submit

January 20, 2016

Conditions

Lack of Satiety

Keywords

SatietyFood intakeYogurt

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Food intake

    One week

Study Arms (2)

Yogurt with added inulin

ACTIVE COMPARATOR

Yogurt with 6g of added inulin

Other: Yogurt

Regular yogurt

PLACEBO COMPARATOR

Regular yogurt without added inulin

Other: Yogurt

Interventions

YogurtOTHER
Regular yogurtYogurt with added inulin

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Human Nutraceutical Research Unit, University of Guelph

Guelph, Ontario, N1G2W1, Canada

Location

MeSH Terms

Interventions

Yogurt

Intervention Hierarchy (Ancestors)

Cultured Milk ProductsMilkBeveragesDiet, Food, and NutritionPhysiological PhenomenaFermented FoodsDairy ProductsFoodFood and Beverages

Study Officials

  • Amanda J Wright, Ph.D.

    University of Guelph

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Manager, HNRU

Study Record Dates

First Submitted

June 15, 2011

First Posted

June 23, 2011

Study Start

February 1, 2013

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

January 21, 2016

Record last verified: 2016-01

Locations

CA(1)