Appetitive BehaviorNCT03319615
The Effect of Fat Mass, Fat-free Mass and Resting Metabolic Rate on Energy Intake
A study testing Dietary energy restriction in people with Appetitive Behavior, run by University of Leeds at 1 site in United Kingdom.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Appetitive Behavior
- What is being tested?
- Dietary energy restriction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 242 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jan 1998to 1 Jan 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Weight stable (weight change of <2 kg in the previous three months)
- Non smoker
- Not dieting,
- No history of eating disorders,
- Free from disease
Who cannot join
- Taking medication known to effect metabolism or appetite
- Pregnant
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Leeds
Leeds, West Yorkshire, LS2 9JT
About this study
Official title: Biological and Psychological Mediators of the Relationships Between Fat Mass, Fat-free Mass and Energy Intake
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.
- Conditions
- Appetitive Behavior
- Being tested
- Dietary energy restriction
- Keywords
- Appetite, Energy Intake, Body Composition, Energy Expenditure
- Medical subject headings
- Appetitive Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary energy restrictionBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Habitual dietary intake | No intervention | Habitual dietary intake |
| Energy Restriction | Experimental | Match period (to comparator) of dietary energy restriction Receives: Behavioral: Dietary energy restriction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Energy Intake- weighed dietary record method
Cross-sectional measurement of energy intake taken at baseline using the weighed dietary record method
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2017
- Study start1 Jan 1998
- Primary completion1 Jan 2007
- Study completion1 Jan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Appetitive BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The baseline non-intervention control arm only used in the present secondary data analysis
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 242 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leeds
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Graham Finlayson, University of Leeds
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03319615
- Sponsor's protocol ID
- FSNHop001
- Status last verified
- Oct 2017
- First submitted
- 19 Oct 2017
- Last updated
- 24 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biological and Psychological Mediators of the Relationships Between Fat Mass, Fat-free Mass and Energy Intake
- ClinicalTrials.gov ID
- NCT03319615
- Acronym / sponsor ID
- FSNHop001
- Conditions
- Appetitive Behavior
- Keywords
- Appetite, Energy Intake, Body Composition, Energy Expenditure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 242 participants (actual)
- Lead sponsor
- University of LeedsUniversity, hospital or other
- Study start
- 1 Jan 1998 (actual)
- Primary completion
- 1 Jan 2007 (actual)
- Study completion
- 1 Jan 2007 (actual)
- First posted
- 24 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The baseline non-intervention control arm only used in the present secondary data analysis
| Arm | Type | Receives |
|---|---|---|
| Habitual dietary intake | No intervention | –Habitual dietary intake |
| Energy Restriction | Experimental | Behavioral: Dietary energy restrictionMatch period (to comparator) of dietary energy restriction |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Weight stable (weight change of <2 kg in the previous three months)
- Non smoker
- Not dieting,
- No history of eating disorders,
- Free from disease
Key exclusion criteria (2 listed)
- Taking medication known to effect metabolism or appetite
- Pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary energy restriction | Behavioural | Energy Restriction |
Primary outcome
Energy Intake- weighed dietary record method
Time frame: Baseline
Cross-sectional measurement of energy intake taken at baseline using the weighed dietary record method
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2017.
- Individual participant dataSharing planned: No
Related trials for Appetitive Behavior
Active, not recruitingObservational study
Appetitive Conditioning in Anorexia Nervosa
Anorexia Nervosa
Recruiting
Behavioral Approach for Latinas Addressing Nutrition, Cravings, and Eating Patterns to Prevent Type 2 Diabetes
Prediabetes, Obesity (Body Mass Index >30 kg/m2)
Recruiting
Validation of a Novel Cerebellar-striatal Satiety Circuit in Humans
Appetitive Behavior, Obesity
Recruiting
Exercise, Brain Activity, and Weight Maintenance
Obesity, Weight Gain
RecruitingPhase 4
Metabolic and Behavioural Effects of CONTRAVE as Potential Mechanisms of Weight Loss in Adults With Obesity
Obesity, Weight Loss
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary energy restriction in people with Appetitive Behavior, run by University of Leeds at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Energy Intake- weighed dietary record method (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2017.