NCT03319615

Brief Summary

The present study was based on secondary analysis using the non-intervention control conditions of five separate studies with common measures. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
242

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 1998

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1998

Completed
9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
10.8 years until next milestone

First Submitted

Initial submission to the registry

October 19, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 24, 2017

Completed
Last Updated

October 24, 2017

Status Verified

October 1, 2017

Enrollment Period

9 years

First QC Date

October 19, 2017

Last Update Submit

October 23, 2017

Conditions

Appetitive Behavior

Keywords

AppetiteEnergy IntakeBody CompositionEnergy Expenditure

Outcome Measures

Primary Outcomes (1)

  • Energy Intake- weighed dietary record method

    Cross-sectional measurement of energy intake taken at baseline using the weighed dietary record method

    Baseline

Study Arms (2)

Habitual dietary intake

NO INTERVENTION

Habitual dietary intake

Energy Restriction

EXPERIMENTAL

Match period (to comparator) of dietary energy restriction

Behavioral: Dietary energy restriction

Interventions

Dietary energy restrictionBEHAVIORAL
Energy Restriction

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Weight stable (weight change of \<2 kg in the previous three months)
  • Non smoker
  • Not dieting,
  • No history of eating disorders,
  • Free from disease

You may not qualify if:

  • Taking medication known to effect metabolism or appetite
  • Pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Leeds

Leeds, West Yorkshire, LS2 9JT, United Kingdom

Location

MeSH Terms

Conditions

Appetitive Behavior

Condition Hierarchy (Ancestors)

Behavior, AnimalBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: The baseline non-intervention control arm only used in the present secondary data analysis
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 19, 2017

First Posted

October 24, 2017

Study Start

January 1, 1998

Primary Completion

January 1, 2007

Study Completion

January 1, 2007

Last Updated

October 24, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)