Overview

This trial is active, not recruiting.

Condition healthy
Treatment fasting
Sponsor Massachusetts General Hospital
Start date September 2012
End date December 2016
Trial size 12 participants
Trial identifier NCT01658397, 2010P001066

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Arm
(Experimental)
Ten day fast
fasting
Ten day fast

Primary Outcomes

Measure
Change in Bone Marrow Adiposity over 10 day fasting period
time frame: Baseline, After 10 day fasting period

Eligibility Criteria

Male or female participants from 21 years up to 45 years old.

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

Additional Information

Official title The Effect of Calorie Deprivation on Adipose Tissue Distribution
Principal investigator Pouneh K Fazeli, MD
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Massachusetts General Hospital.