The Effect of Calorie Deprivation on Adipose Tissue Distribution

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Massachusetts General Hospital
Sponsor:
Information provided by (Responsible Party):
Pouneh K. Fazeli, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01658397
First received: August 1, 2012
Last updated: February 6, 2014
Last verified: February 2014
  Purpose

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
Healthy
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.


Estimated Enrollment: 20
Study Start Date: September 2012
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fasting
Ten day fast
Behavioral: Fasting
Ten day fast

  Eligibility

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01658397

Contacts
Contact: Pouneh K Fazeli, MD 617-726-3870 pkfazeli@partners.org

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Pouneh K Fazeli, MD    617-726-3870    pkfazeli@partners.org   
Principal Investigator: Pouneh K Fazeli, MD         
Sponsors and Collaborators
Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Pouneh K. Fazeli, MD, Instructor in Medicine, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01658397     History of Changes
Other Study ID Numbers: 2010P001066
Study First Received: August 1, 2012
Last Updated: February 6, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
Healthy subjects
Fasting
Weight loss

ClinicalTrials.gov processed this record on July 20, 2014