NCT02696772

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2013

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 26, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 2, 2016

Completed
Last Updated

March 3, 2016

Status Verified

March 1, 2016

Enrollment Period

1.7 years

First QC Date

February 26, 2016

Last Update Submit

March 1, 2016

Conditions

Deficiency; Calorie

Outcome Measures

Primary Outcomes (4)

  • Ad-libitum energy intake

    Measured at laboratory-based meals and weight food records

    48 hours

  • Subjective appetite

    Measured using visual analogue scales

    48 hours

  • Plasma acylated Ghrelin

    Measured using ELISA from venous blood samples

    24 hours

  • Plasma active glugagon-like peptide 1

    Measured using ELISA from venous blood samples

    24 hours

Secondary Outcomes (6)

  • Plasma insulin

    24 hours

  • Plasma glucose

    24 hours

  • Plasma Non-esterified Fatty acids

    24 hours

  • Energy expenditure

    24 hours

  • Fat oxidation

    24 hours

  • +1 more secondary outcomes

Study Arms (2)

Energy balance

EXPERIMENTAL

Intervention day diet containing 100% of estimated energy requirements

Other: Energy intake

Energy restriction

EXPERIMENTAL

Intervention day diet containing 25% of estimated energy requirements

Other: Energy intake

Interventions

Energy intakeOTHER
Energy balanceEnergy restriction

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • non-smoker, not currently dieting, weight stable for \>6 months (self-reported), no known history of cardiovascular or renal disease.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 27806971DERIVED

MeSH Terms

Interventions

Energy Intake

Intervention Hierarchy (Ancestors)

DietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer in Nutrition

Study Record Dates

First Submitted

February 26, 2016

First Posted

March 2, 2016

Study Start

October 1, 2013

Primary Completion

June 1, 2015

Study Completion

September 1, 2015

Last Updated

March 3, 2016

Record last verified: 2016-03

Data Sharing

IPD Sharing
Will not share