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CompletedNCT03319615Updated Oct 24, 2017

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

An interventional study of Dietary energy restriction in Appetitive Behavior, sponsored by University of Leeds. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-10-24.

Sponsored by University of Leeds · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Registered 19 years 9 months after the study started (first participant enrolled Jan 1998, registered Oct 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
242
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Appetitive Behavior

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Keywords

  • Appetite
  • Energy Intake
  • Body Composition
  • Energy Expenditure
03

In context

Appetitive Behavior

96 studies on the registry are indexed under Appetitive Behavior; 6 are open to participants now.

This study's enrollment of 242 is above the median of 26 across 87 interventional studies indexed under Appetitive Behavior.

Browse Appetitive Behavior studies →

Lead sponsor

University of Leeds is the lead sponsor of 206 studies on the registry; 25 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Taking medication known to effect metabolism or appetite
  • Pregnant
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
242 participants (actual)

Study arms

  • No intervention
    Habitual dietary intake

    Habitual dietary intake

  • Experimental
    Energy Restriction

    Match period (to comparator) of dietary energy restriction

    Behavioral: Dietary energy restriction

Interventions

  • BehavioralDietary energy restriction
06

What researchers measure

Primary outcomes

  1. Energy Intake- weighed dietary record method

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

    Time frame: Baseline

07

Study locations

1 site
  • University of Leeds
    Leeds, West Yorkshire LS2 9JT, United Kingdom
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 1998 to primary completion in Jan 2007, 108 months.

Of 75 non-industry interventional studies with no phase under Appetitive Behavior, half reached primary completion within 7 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 16. This study's 108 months is above that.

Counting every sponsor, half of 76 studies reached it within 7 months; a quarter within 3 and three quarters within 16.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 19, 2017
First posted
Oct 24, 2017
StartActual
Jan 1, 1998
Primary completionActual
Jan 1, 2007
CompletionActual
Jan 1, 2007
Last update
Oct 24, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 24, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03319615
Responsible party
Dr Graham Finlayson (Associate Professor, University of Leeds) — Principal investigator
First posted
Oct 24, 2017
Start date
Jan 1, 1998
Primary completion
Jan 1, 2007
Completion
Jan 1, 2007
Last update
Oct 24, 2017

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.

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