- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02696772
Effect of 24 h Severe Energy Restriction on Appetite Regulation and Ad-libitum Energy Intake
March 1, 2016 updated by: Lewis James, Loughborough University
Effect of 24 h Severe Energy Restriction on Appetite Regulation and Ad-libitum Energy Intake in Lean Males and Females
Long term maintenance of weight loss is generally poor, which is at least partly due to increased feelings of hunger associated with restricting what can be eaten.
Intermittent severe energy restriction is a novel dietary strategy that requires individuals to consume a very-low energy diet for 1-4 days per week, allowing normal feeding patterns to be adopted on the other days in the week.
However, the effect of a consuming a very-low energy diet on appetite regulation, which might represent a key marker of long-term adherence to dieting, has not been determined.
This study aimed to assess the effects of severely restricting energy intake for 24 h on markers of appetite regulation, energy balance and metabolism compared to an adequate energy trial.
Study Overview
Study Type
Interventional
Enrollment (Actual)
18
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- non-smoker, not currently dieting, weight stable for >6 months (self-reported), no known history of cardiovascular or renal disease.
Exclusion Criteria:
- food allergies, dislike or intolerance of study foods and drinks, irregular eating patterns, use of medication that could influence hormone concentrations, excessive alcohol consumption (>4 units/day), intensive training schedule (>10 h/week)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Energy balance
Intervention day diet containing 100% of estimated energy requirements
|
|
Experimental: Energy restriction
Intervention day diet containing 25% of estimated energy requirements
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ad-libitum energy intake
Time Frame: 48 hours
|
Measured at laboratory-based meals and weight food records
|
48 hours
|
Subjective appetite
Time Frame: 48 hours
|
Measured using visual analogue scales
|
48 hours
|
Plasma acylated Ghrelin
Time Frame: 24 hours
|
Measured using ELISA from venous blood samples
|
24 hours
|
Plasma active glugagon-like peptide 1
Time Frame: 24 hours
|
Measured using ELISA from venous blood samples
|
24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Plasma insulin
Time Frame: 24 hours
|
Measured using ELISA from venous blood samples
|
24 hours
|
Plasma glucose
Time Frame: 24 hours
|
Measured using colorimetric assay from venous blood samples
|
24 hours
|
Plasma Non-esterified Fatty acids
Time Frame: 24 hours
|
Measured using colorimetric from venous blood samples
|
24 hours
|
Energy expenditure
Time Frame: 24 hours
|
Measured under resting conditions using indirect calorimetry
|
24 hours
|
Fat oxidation
Time Frame: 24 hours
|
Measured under resting conditions using indirect calorimetry
|
24 hours
|
carbohydrate oxidation
Time Frame: 24 hors
|
Measured under resting conditions using indirect calorimetry
|
24 hors
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2013
Primary Completion (Actual)
June 1, 2015
Study Completion (Actual)
September 1, 2015
Study Registration Dates
First Submitted
February 26, 2016
First Submitted That Met QC Criteria
February 26, 2016
First Posted (Estimate)
March 2, 2016
Study Record Updates
Last Update Posted (Estimate)
March 3, 2016
Last Update Submitted That Met QC Criteria
March 1, 2016
Last Verified
March 1, 2016
More Information
Terms related to this study
Other Study ID Numbers
- R13-P149DC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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