The Effect of Calorie Deprivation on Adipose Tissue Distribution

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Pouneh K. Fazeli, MD, Massachusetts General Hospital Identifier:
First received: August 1, 2012
Last updated: February 27, 2016
Last verified: February 2016
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.

Condition Intervention
Behavioral: Fasting

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: The Effect of Calorie Deprivation on Adipose Tissue Distribution

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Change in Bone Marrow Adiposity over 10 day fasting period [ Time Frame: Baseline, After 10 day fasting period ] [ Designated as safety issue: No ]
    Bone marrow adiposity will be measured before and after the 10 day fast using magnetic resonance spectroscopy.

Enrollment: 12
Study Start Date: September 2012
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fasting
Ten day fast
Behavioral: Fasting
Ten day fast


Ages Eligible for Study:   21 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01658397

United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Principal Investigator: Pouneh K Fazeli, MD Massachusetts General Hospital
  More Information

Responsible Party: Pouneh K. Fazeli, MD, Assistant Professor of Medicine, Massachusetts General Hospital Identifier: NCT01658397     History of Changes
Other Study ID Numbers: 2010P001066 
Study First Received: August 1, 2012
Last Updated: February 27, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
Healthy subjects
Weight loss processed this record on May 26, 2016