The Effect of Calorie Deprivation on Adipose Tissue Distribution
1 other identifier
interventional
12
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable healthy
Started Sep 2012
Typical duration for not_applicable healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 1, 2012
CompletedFirst Posted
Study publicly available on registry
August 7, 2012
CompletedStudy Start
First participant enrolled
September 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 21, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
July 21, 2014
CompletedFebruary 10, 2017
February 1, 2017
1.9 years
August 1, 2012
February 8, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Bone Marrow Adiposity over 10 day fasting period
Bone marrow adiposity will be measured before and after the 10 day fast using magnetic resonance spectroscopy.
Baseline, After 10 day fasting period
Study Arms (1)
Fasting
EXPERIMENTALTen day fast
Interventions
Eligibility Criteria
You may qualify if:
- Men and women, ages 21-45 years
- % 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pouneh K Fazeli, MD
Massachusetts General Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Medicine
Study Record Dates
First Submitted
August 1, 2012
First Posted
August 7, 2012
Study Start
September 1, 2012
Primary Completion
July 21, 2014
Study Completion
July 21, 2014
Last Updated
February 10, 2017
Record last verified: 2017-02