Effect of 24 h Severe Energy Restriction on Appetite Regulation and Ad-libitum Energy Intake

NCT ID: NCT02696772

Last Updated: 2016-03-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2015-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Deficiency; Calorie

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Energy balance

Intervention day diet containing 100% of estimated energy requirements

Group Type EXPERIMENTAL

Energy intake

Intervention Type OTHER

Energy restriction

Intervention day diet containing 25% of estimated energy requirements

Group Type EXPERIMENTAL

Energy intake

Intervention Type OTHER

Interventions

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Energy intake

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute for Health Research, United Kingdom

OTHER_GOV

Sponsor Role collaborator

Loughborough University

OTHER

Sponsor Role lead

Responsible Party

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Lewis James

Lecturer in Nutrition

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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Clayton DJ, Burrell K, Mynott G, Creese M, Skidmore N, Stensel DJ, James LJ. Effect of 24-h severe energy restriction on appetite regulation and ad libitum energy intake in lean men and women. Am J Clin Nutr. 2016 Dec;104(6):1545-1553. doi: 10.3945/ajcn.116.136937. Epub 2016 Nov 2.

Reference Type DERIVED
PMID: 27806971 (View on PubMed)

Other Identifiers

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R13-P149DC

Identifier Type: -

Identifier Source: org_study_id

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