- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03319615
The Effect of Fat Mass, Fat-free Mass and Resting Metabolic Rate on Energy Intake
Biological and Psychological Mediators of the Relationships Between Fat Mass, Fat-free Mass and Energy Intake
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The current analysis examine the indirect and direct effects of fat-free mass, fat mass and resting metabolic rate on energy intake in individuals at or close to energy balance.
The present study was based on secondary analysis using the non-intervention control conditions of five separate studies conducted between the dates of 1998 and 2007. In total, 242 subjects (114 males; 128 females; mean body mass index = 25.6 ± 5.0 kg/m2) were included. In these studies, body composition (air displacement plethysmography), energy expenditure (indirect calorimetry and flex heart rate) and energy intake (weighed dietary records) were measured using common procedures.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
West Yorkshire
-
Leeds, West Yorkshire, United Kingdom, LS2 9JT
- University of Leeds
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Weight stable (weight change of <2 kg in the previous three months)
- Non smoker
- Not dieting,
- No history of eating disorders,
- Free from disease
Exclusion Criteria:
- Taking medication known to effect metabolism or appetite
- Pregnant
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Habitual dietary intake
|
|
|
Experimental: Energy Restriction
Match period (to comparator) of dietary energy restriction
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Energy Intake- weighed dietary record method
Time Frame: Baseline
|
Cross-sectional measurement of energy intake taken at baseline using the weighed dietary record method
|
Baseline
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- FSNHop001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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