Effects of a Variety of Meals on Satiety

October 22, 2012 updated by: The Hillshire Brands Company

A Randomized, Controlled Crossover Trial to Assess the Effects of Varying Meals on Satiety

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

38

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Composite Area under the Curve - Visual Analog Scale
Time Frame: Acute - up to 4 hrs
Acute - up to 4 hrs

Secondary Outcome Measures

Outcome Measure
Time Frame
Individual satiety measures - Area under the curve
Time Frame: 4 hrs
4 hrs

Other Outcome Measures

Outcome Measure
Time Frame
Differences between test conditions in food intake, energy intake and areas under the curve.
Time Frame: 4 hrs
4 hrs

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Hillshire Brands Company

Collaborators

Biofortis Clinical Research, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (ANTICIPATED)

August 1, 2013

Study Registration Dates

First Submitted

October 22, 2012

First Submitted That Met QC Criteria

October 22, 2012

First Posted (ESTIMATE)

October 24, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

October 24, 2012

Last Update Submitted That Met QC Criteria

October 22, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Other Study ID Numbers

  • PRV1223

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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