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The Effect of Calorie Deprivation on Adipose Tissue Distribution

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01658397
First Posted: August 7, 2012
Last Update Posted: February 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Pouneh K. Fazeli, MD, Massachusetts General Hospital
  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: None (Open Label)
Primary Purpose: Other
Official Title: The Effect of Calorie Deprivation on Adipose Tissue Distribution

Further study details as provided by Pouneh K. Fazeli, MD, Massachusetts General Hospital:

Primary Outcome Measures:
  • Change in Bone Marrow Adiposity over 10 day fasting period [ Time Frame: Baseline, After 10 day fasting period ]
    Bone marrow adiposity will be measured before and after the 10 day fast using magnetic resonance spectroscopy.


Enrollment: 12
Study Start Date: September 2012
Study Completion Date: July 21, 2014
Primary Completion Date: July 21, 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fasting
Ten day fast
Behavioral: Fasting
Ten day fast

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01658397


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

Responsible Party: Pouneh K. Fazeli, MD, Assistant Professor of Medicine, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01658397     History of Changes
Other Study ID Numbers: 2010P001066
First Submitted: August 1, 2012
First Posted: August 7, 2012
Last Update Posted: February 10, 2017
Last Verified: February 2017

Keywords provided by Pouneh K. Fazeli, MD, Massachusetts General Hospital:
Healthy subjects
Fasting
Weight loss