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Clinical Trials/NCT01713114
NCT01713114
Unknown
N/A

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

The Hillshire Brands Company1 site in 1 country38 target enrollmentOctober 2012

Overview

Phase
N/A
Intervention
Not specified
Conditions
Focus of the Study is Satiety
Sponsor
The Hillshire Brands Company
Enrollment
38
Locations
1
Primary Endpoint
Composite Area under the Curve - Visual Analog Scale
Last Updated
13 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
October 2012
End Date
August 2013
Last Updated
13 years ago
Study Type
Interventional
Study Design
Crossover
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility 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)

Outcomes

Primary Outcomes

Composite Area under the Curve - Visual Analog Scale

Time Frame: Acute - up to 4 hrs

Secondary Outcomes

  • Individual satiety measures - Area under the curve(4 hrs)

Study Sites (1)

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