Recruiting

Satiety

Sponsor:

The Hillshire Brands Company

Code:

NCT01713114

Conditions

Focus of the Study is Satiety

Eligibility Criteria

Sex: Female

Age: 18 - 55

Healthy Volunteers: Accepted

Interventions

Acute measures of satiety and food intake at next meal

Study Details

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.

Conditions

Focus of the Study is Satiety

Study ID

NCT01713114

Start date

Oct, 2012

Status verified date

Oct, 2012

Primary completion date

Aug, 2013

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 55

Healthy Volunteers: Accepted

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 Design

Enrollment

38 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Interventions and Outcome Measures

Arms

experimental: Low carbohydrate

experimental: Moderate carbohydrate

experimental: Higher Carbohydrate

placebo comparator: Meal Skipping

Interventions

Acute measures of satiety and food intake at next meal

Primary outcome measure

  • Composite Area under the Curve - Visual Analog Scale [ Time Frame: Acute - up to 4 hrs ]

Central Contacts and Locations

Locations

Biofortis Clinical Research

Recruiting

Addison, Illinois, United States, 60101

Contacts

Andrea Lawless, MD

Andrea.Lawless@mxns.com

Kristen Sanoshy

kristen.sanoshy@mxns.com

More Information

Sponsor

The Hillshire Brands Company

Last update posted

Oct 24, 2012

Last verified

Oct, 2012

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The Hillshire Brands Company on 2012-10-24.