Effects of a Variety of Meals on Satiety

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 23, 2014