Reduced Carbohydrate Versus Fat in Obese Subjects

NCT00846040 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2021-04-15

Study results available
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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.

Conditions

Interventions

OTHER

Reduced fat diet

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

OTHER

Reduced carbohydrate diet

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

DRUG

Drug: f-18 fallypride

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.

DEVICE

fMRI

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

DEVICE

PET

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

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    lead NIH

Principal Investigators

  • Kevin Hall, Ph.D. · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-02-13
Primary Completion
2014-02-24
Completion
2014-10-20
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00846040 on ClinicalTrials.gov