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Effects of a Variety of Meals on Satiety

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ClinicalTrials.gov Identifier: NCT01713114
Recruitment Status : Unknown
Verified October 2012 by The Hillshire Brands Company.
Recruitment status was:  Recruiting
First Posted : October 24, 2012
Last Update Posted : October 24, 2012
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Focus of the Study is Satiety 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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Official Title: A Randomized, Controlled Crossover Trial to Assess the Effects of Varying Meals on Satiety
Study Start Date : October 2012
Estimated Primary Completion Date : August 2013
Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Composite Area under the Curve - Visual Analog Scale [ Time Frame: Acute - up to 4 hrs ]

Secondary Outcome Measures :
  1. Individual satiety measures - Area under the curve [ Time Frame: 4 hrs ]

Other Outcome Measures:
  1. Differences between test conditions in food intake, energy intake and areas under the curve. [ Time Frame: 4 hrs ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes 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

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): 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, Inc.
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: The Hillshire Brands Company
ClinicalTrials.gov Identifier: NCT01713114     History of Changes
Other Study ID Numbers: PRV1223
First Posted: October 24, 2012    Key Record Dates
Last Update Posted: October 24, 2012
Last Verified: October 2012