The Effects of Acute Weight Gain and Acute Calorie Deprivation on Marrow Adipose Tissue

Completed · Not applicable

Conditions studied: Healthy

In brief

Marrow adipocytes have been identified as a component of the bone marrow micro-environment. Evidence exists suggesting that marrow fat plays an important physiologic role in both bone mineral and energy metabolism in humans. The investigators will study the effects of acute weight gain and acute nutritional deprivation on energy homeostasis and bone mineral metabolism by examining marrow adiposity, peripheral fat depots and bone microarchitecture. The study will include two ten day inpatient study visits. Participants will eat a high calorie diet for 10 days, followed by a 13-18 day stabilization period at home, and then return for a ten day fast.

Key facts

Study ID

NCT02482519

Run by

Massachusetts General Hospital

People needed

28

Starts

2015-11-01

Expected to finish

2018-04-01

Last updated by the study team

2023-01-04

Who can join

Age: 21 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Men and women, ages 21-45 years
• 101-120% of ideal body weight as defined by the 1983 Metropolitan Life Insurance Height and Weight Tables
• Normal thyroid function
• Regular menses (women) - Female subjects will start the study within 1 week of Day 1 of their menstrual period
• Normal transaminase levels (AST/ALT)

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
• History of eating disorder
• Pregnant and/or breastfeeding (women)
• Diabetes mellitus
• Active substance abuse, including alcohol
• Contraindications to MRI: cardiac pacemaker, metal implants, claustrophobia
• History of chemotherapy or radiation therapy
• History of a bleeding disorder or use of anti-platelet medications
• Allergy to allopurinol
• The study physician feels that the subject may not be able to safely complete the study or may place themselves at risk by undergoing the study

Where it is running

• Massachusettes General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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