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Effects of a Variety of Meals on Satiety

NCT ID: NCT01713114

Last Updated: 2012-10-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Brief Summary

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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

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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.

Conditions

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Focus of the Study is Satiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Low carbohydrate

Group Type EXPERIMENTAL

Acute measures of satiety and food intake at next meal

Intervention Type OTHER

Moderate carbohydrate

Group Type EXPERIMENTAL

Acute measures of satiety and food intake at next meal

Intervention Type OTHER

Higher Carbohydrate

Group Type EXPERIMENTAL

Acute measures of satiety and food intake at next meal

Intervention Type OTHER

Meal Skipping

Group Type PLACEBO_COMPARATOR

Acute measures of satiety and food intake at next meal

Intervention Type OTHER

Interventions

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Acute measures of satiety and food intake at next meal

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Biofortis Clinical Research, Inc.

INDUSTRY

Sponsor Role collaborator

The Hillshire Brands Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Biofortis Clinical Research

Addison, Illinois, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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Andrea Lawless, MD

Role: primary

Kristen Sanoshy

Role: backup

References

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Rains TM, Leidy HJ, Sanoshy KD, Lawless AL, Maki KC. A randomized, controlled, crossover trial to assess the acute appetitive and metabolic effects of sausage and egg-based convenience breakfast meals in overweight premenopausal women. Nutr J. 2015 Feb 10;14:17. doi: 10.1186/s12937-015-0002-7.

Reference Type DERIVED
PMID: 25889354 (View on PubMed)

Other Identifiers

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PRV1223

Identifier Type: -

Identifier Source: org_study_id