Effects of a Variety of Meals on Satiety

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

Sponsors

Lead Sponsor: The Hillshire Brands Company

Collaborator: Biofortis Clinical Research, Inc.

Source The Hillshire Brands Company
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.

Overall Status Unknown status
Start Date October 2012
Primary Completion Date August 2013
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Composite Area under the Curve - Visual Analog Scale Acute - up to 4 hrs
Secondary Outcome
Measure Time Frame
Individual satiety measures - Area under the curve 4 hrs
Enrollment 38
Condition
Intervention

Intervention Type: Other

Intervention Name: Acute measures of satiety and food intake at next meal

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)

- Subject is pregnant or planning to become pregnant during the study period

Gender: Female

Minimum Age: 18 Years

Maximum Age: 55 Years

Healthy Volunteers: Accepts Healthy Volunteers

Location
Facility: Status: Contact: Contact Backup: Biofortis Clinical Research Andrea Lawless, MD [email protected]
Location Countries

United States

Verification Date

October 2012

Responsible Party

Type: Sponsor

Has Expanded Access No
Number Of Arms 4
Arm Group

Label: Low carbohydrate

Type: Experimental

Label: Moderate carbohydrate

Type: Experimental

Label: Higher Carbohydrate

Type: Experimental

Label: Meal Skipping

Type: Placebo Comparator

Study Design Info

Allocation: Randomized

Intervention Model: Crossover Assignment

Masking: Double (Participant, Outcomes Assessor)

Source: ClinicalTrials.gov