Effects of a Variety of Meals on Satiety
A Randomized, Controlled Crossover Trial to Assess the Effects of Varying Meals on Satiety
1 other identifier
interventional
38
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2012
CompletedFirst Submitted
Initial submission to the registry
October 22, 2012
CompletedFirst Posted
Study publicly available on registry
October 24, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2013
CompletedOctober 24, 2012
October 1, 2012
10 months
October 22, 2012
October 22, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Composite Area under the Curve - Visual Analog Scale
Acute - up to 4 hrs
Secondary Outcomes (1)
Individual satiety measures - Area under the curve
4 hrs
Other Outcomes (1)
Differences between test conditions in food intake, energy intake and areas under the curve.
4 hrs
Study Arms (4)
Low carbohydrate
EXPERIMENTALModerate carbohydrate
EXPERIMENTALHigher Carbohydrate
EXPERIMENTALMeal Skipping
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- premenopausal Females
- Ages 18-55
- BMI between 18.5-29.9
- Willing to maintain weight throughout study period
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- The Hillshire Brands Companylead
- Biofortis Clinical Research, Inc.collaborator
Study Sites (1)
Biofortis Clinical Research
Addison, Illinois, 60101, United States
Related Publications (1)
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.
PMID: 25889354DERIVED
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 22, 2012
First Posted
October 24, 2012
Study Start
October 1, 2012
Primary Completion
August 1, 2013
Last Updated
October 24, 2012
Record last verified: 2012-10