CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 43 enrolled
Drug / intervention
Drug: f-18 fallypride +4 moredrug
Likely dose
Not stated in record
Key inclusion· 7
  • ✓Age 18-45 years
  • ✓BMI ≥30 kg/m² (obese cohort) or BMI 18.5-25 kg/m² (control cohort)
  • ✓Weight stable (±5 kg over past 6 months)
  • ✓Body weight <350 lbs (may increase to 400 lbs after large bore fMRI acquisition)
Key exclusion· 10
  • ✕Metabolic or cardiovascular disease or conditions affecting metabolism (cancer, diabetes, thyroid disease)
  • ✕Use of prescription medications (except birth control) or drugs affecting metabolism
  • ✕History of eating disorder (including binge eating) or psychiatric disease
  • ✕Regular substance use: alcohol >2 drinks/day, tobacco, amphetamines, cocaine, heroin, marijuana (past 6 months)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00846040
NCT00846040Phase 2Completed
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Selective Reduction of Dietary Carbohydrate Versus Fat: Effects on Metabolism, Endocrine Physiology, Brain Activity and Reward Circuitry

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)·interventional·Posted Feb 18, 2009·Updated Apr 15, 2021

In Brief

A Phase 2 clinical trial evaluating Reduced fat diet, Reduced carbohydrate diet, and 3 other interventions for Obesity. Completed, enrolled 43 participants across 1 site.

Detailed Summary

Popular weight loss strategies often involve reducing an individual's consumption of carbohydrates or fat. However, no controlled study has been carried out to evaluate the effects of reducing carbohydrate versus fat consumption while keeping the other nutrients at standard levels to maintain an individual's weight. Researchers are interested in investigating how different restrictions of carbohydrates or fats affect the many processes involved in weight loss, including brain activity and blood and brain chemical composition.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsObesity
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 18, 2009
Enrollment StartFeb 13, 2009
Primary CompletionFeb 24, 2014
Study CompletionOct 20, 2014
TodayJul 2, 2026
Enrollment to primary: 5.0 yearsPosted 17.4 years ago

Interventions

Reduced fat dietother

RF (selective reduction of 85% of baseline fat calories per day)

Reduced carbohydrate dietother

RC (selective reduction of 60% of baseline carbohydrate calories per day)

Drug: f-18 fallypridedrug

Dopamine D2 receptor availability is measured by positron emission tomography (PET) using the positron emitting compound \[18F\] fallypride which binds competitively with dopamine to the D2 receptor.

fMRIdevice

Functional MRI (fMRI) will be used to measure the effects of diet and weight loss on regional brain activity

PETdevice

Positron emission tomography (PET) will be used to assess whether To assess whether brain activity and reward pathways are altered