The Effect of Fat Mass, Fat-free Mass and Resting Metabol... | NCT03319615

Studies
The Effect of Fat Mass, Fat-free Mass and Resting Metabolic Rate on Energy Intake

NCT03319615

Sponsor

University of Leeds

Status

Completed

Last Update Posted

Oct 24, 2017Actual

Enrollment

242Actual

Phase

Not Applicable

Conditions

Appetitive Behavior

Interventions

Dietary energy restriction

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 1998Actual

Primary Completion Date

Jan 1, 2007Actual

Completion Date

Jan 1, 2007Actual

First Submitted Date

Oct 19, 2017

First Submission Date that Met QC Criteria

Oct 23, 2017

First Posted Date

Oct 24, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 23, 2017

Last Update Posted Date

Oct 24, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

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.

The present study was based on secondary analysis using the non-intervention control conditions of five separate studies conducted between the dates of 1998 and 2007. In total, 242 subjects (114 males; 128 females; mean body mass index = 25.6 ± 5.0 kg/m2) were included. In these studies, body composition (air displacement plethysmography), energy expenditure (indirect calorimetry and flex heart rate) and energy intake (weighed dietary records) were measured using common procedures.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

242Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Habitual dietary intake	No Intervention	Habitual dietary intake
Energy Restriction	Experimental	Match period (to comparator) of dietary energy restriction	Behavioral: Dietary energy restriction

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dietary energy restriction	Behavioral		Energy Restriction

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Energy Intake- weighed dietary record method	Cross-sectional measurement of energy intake taken at baseline using the weighed dietary record method	Baseline

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Taking medication known to effect metabolism or appetite
Pregnant

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Leeds		Leeds	West Yorkshire	LS2 9JT	United Kingdom

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001070	Appetitive Behavior

Ancestor Terms

ID	Term
D001522	Behavior, Animal
D001519	Behavior

Browse Leaves

Not provided

Browse Branches

Not provided