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Effects of a Variety of Meals on Satiety

This study is currently recruiting participants.
Verified October 2012 by The Hillshire Brands Company
Sponsor:
Collaborator:
Biofortis Clinical Research
Information provided by (Responsible Party):
The Hillshire Brands Company
ClinicalTrials.gov Identifier:
NCT01713114
First received: October 22, 2012
Last updated: NA
Last verified: October 2012
History: No changes posted
  Purpose

The primary objective of this study is to assess the acute effects of different meals on satiety. It is hypothesized that a lower carbohydrate meal will result in greater feelings of satiety and reduced food intake at a subsequent meal compared to the higher-carbohydrate or meal skipping conditions.


Condition Intervention
Focus of the Study is Satiety
 Other: Acute measures of satiety and food intake at next meal

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Official Title: A Randomized, Controlled Crossover Trial to Assess the Effects of Varying Meals on Satiety

Further study details as provided by The Hillshire Brands Company:

Primary Outcome Measures:
  • Composite Area under the Curve - Visual Analog Scale [ Time Frame: Acute - up to 4 hrs ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Individual satiety measures - Area under the curve [ Time Frame: 4 hrs ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Differences between test conditions in food intake, energy intake and areas under the curve. [ Time Frame: 4 hrs ] [ Designated as safety issue: No ]

Estimated Enrollment: 38
Study Start Date: October 2012
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Low carbohydrate Other: Acute measures of satiety and food intake at next meal
Experimental: Moderate carbohydrate Other: Acute measures of satiety and food intake at next meal
Experimental: Higher Carbohydrate Other: Acute measures of satiety and food intake at next meal
Placebo Comparator: Meal Skipping Other: Acute measures of satiety and food intake at next meal

Detailed Description:

Satiety refers to feelings of fullness or lack of desire to eat following consumption of a food or meal. A number of dietary factors have been shown to influence satiety, including food volume, food weight, energy density, food palatability, and certain food ingredients. The nutritional composition of a meal appears to also play a significant role in an individual's feelings of satiety and ability to stay full until the next meal.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • premenopausal Females
  • Ages 18-55
  • BMI between 18.5-29.9
  • Willing to maintain weight throughout study period

Exclusion Criteria:

  • Subject has a history of any surgical intervention for the treatment of obesity
  • Recent history or use of weight loss drugs, herbal supplements or on a dieting program or trying to loose weight
  • Gains or loses more than 6 pounds over the study period
  • Current or history of an eating disorder
  • Restrained eater
  • Excludes any foods or meals from their diet
  • History or presence of clinically important cardiac, renal, hepatic, endocrine, pulmonary, gastrointestinal, biliary, pancreatic or neurologic disorders
  • Signs of an infection
  • Heavy user of caffeine or alcohol
  • Unconventional sleep patterns (e.g. works 3rd shift)
  • Subject is pregnant or planning to become pregnant during the study period
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01713114

Locations
United States, Illinois
Biofortis Clinical Research Recruiting
Addison, Illinois, United States, 60101
Contact: Andrea Lawless, MD         Andrea.Lawless@mxns.com    
Contact: Kristen Sanoshy         kristen.sanoshy@mxns.com    
Sponsors and Collaborators
The Hillshire Brands Company
Biofortis Clinical Research
  More Information

No publications provided

Responsible Party: The Hillshire Brands Company
ClinicalTrials.gov Identifier: NCT01713114     History of Changes
Other Study ID Numbers: PRV1223
Study First Received: October 22, 2012
Last Updated: October 22, 2012
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on May 22, 2013