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OpenTrials
Completed

NCT Number: NCT01658397

The Effect of Calorie Deprivation on Adipose Tissue Distribution

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.

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Key information

Conditions

Healthy Behavior Body Weight Body Weight Changes Fasting Feeding Behavior Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

21 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fasting

Behavioral

Ten day fast

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Aug 7, 2012
Registry last updated
Feb 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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