The Effect of Calorie Deprivation on Adipose Tissue Distribution

NCT ID: NCT01658397

Last Updated: 2017-02-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2014-07-21

Brief Summary

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In this study, we will be studying the effects of acute calorie deprivation (a 10-day fast) on bone marrow fat, other fat stores and bone parameters. We will be measuring changes in bone marrow fat using magnetic resonance spectroscopy and will use MRI to measure subcutaneous and visceral fat depots. Our hypothesis is that levels of bone marrow fat will increase after an acute fast.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Fasting

Ten day fast

Group Type EXPERIMENTAL

Fasting

Intervention Type BEHAVIORAL

Ten day fast

Interventions

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Fasting

Ten day fast

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Men and women, ages 21-45 years
* 101-130% of ideal body weight as defined by the 1983 Metropolitan Life Insurance Height and Weight Tables
* Normal thyroid function
* Regular menses (women)
* Normal liver transaminases

Exclusion Criteria

* Any disease known to affect bone metabolism, including untreated thyroid dysfunction, Cushing's syndrome, or renal failure
* Any medication known to affect bone metabolism -- including systemic steroids or immunosuppressants -- within three months of the study, excluding estrogen and progestins. Patients receiving depot medroxyprogesterone (Depo-Provera) will be excluded from participating for six months after their last injections. Bisphosphonates must have been discontinued for at least one year before participation
* Serum potassium \<3.0 meq/L
* Pregnant and/or breastfeeding (women)
* Diabetes mellitus
* Active substance abuse, including alcohol
* Contraindications to MRI: cardiac pacemaker, metal implants, claustrophobia
Minimum Eligible Age

21 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Pouneh K. Fazeli, MD

Assistant Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Pouneh K Fazeli, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

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Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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2010P001066

Identifier Type: -

Identifier Source: org_study_id

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