Effects of a Variety of Meals on Satiety

• Sponsor: The Hillshire Brands Company (Industry)
• Overall Status: Unknown status
• CT.gov ID: NCT01713114
• Collaborator: Biofortis Clinical Research, Inc. (Industry)
• Enrollment: 38
• Location: 1
• Arms: 4

Study Details

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	Phase
Focus of the Study is Satiety	Other: Acute measures of satiety and food intake at next meal	N/A

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
• Anticipated 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: Oct 1, 2012
• Anticipated Primary Completion Date: Aug 1, 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 [Acute - up to 4 hrs]

Secondary Outcome Measures

1. Individual satiety measures - Area under the curve [4 hrs]

Other Outcome Measures

1. Differences between test conditions in food intake, energy intake and areas under the curve. [4 hrs]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Biofortis Clinical Research	Addison	Illinois	United States	60101

Sponsors and Collaborators

• The Hillshire Brands Company
• Biofortis Clinical Research, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: The Hillshire Brands Company
• ClinicalTrials.gov Identifier: NCT01713114
• Other Study ID Numbers: PRV1223
• First Posted: Oct 24, 2012
• Last Update Posted: Oct 24, 2012
• Last Verified: Oct 1, 2012

Study Results

No Results Posted as of Oct 24, 2012