A Randomized, Controlled Crossover Trial to Assess the Effects of Varying Meals on Satiety
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- The Hillshire Brands Company
- Enrollment
- 38
- Locations
- 1
- Primary Endpoint
- Composite Area under the Curve - Visual Analog Scale
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- 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
Arms & Interventions
Higher Carbohydrate
Intervention: Acute measures of satiety and food intake at next meal (Other)
Meal Skipping
Intervention: Acute measures of satiety and food intake at next meal (Other)
Moderate carbohydrate
Intervention: Acute measures of satiety and food intake at next meal (Other)
Low carbohydrate
Intervention: Acute measures of satiety and food intake at next meal (Other)
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)