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

Status

Completed

Conditions

Intervention / Treatment

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.

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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