NCT02482519

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Nov 2015

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

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

June 16, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 26, 2015

Completed
4 months until next milestone

Study Start

First participant enrolled

November 1, 2015

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

January 4, 2023

Status Verified

December 1, 2022

Enrollment Period

2.4 years

First QC Date

June 16, 2015

Last Update Submit

December 30, 2022

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Marrow adiposity will be measured using magnetic resonance spectroscopy

    Marrow adipose tissue measurement of the spine and hip

    Change from baseline marrow adipose tissue after high-calorie diet and after fast (35 days)

Study Arms (1)

10 day overfeeding/fasting

OTHER

10 day high calorie diet followed by a 10 day fast

Other: High calorie dietOther: Fasting

Interventions

High calorie dietOTHER

High calorie diet for 10 days

10 day overfeeding/fasting
FastingOTHER

10 day fast

10 day overfeeding/fasting

Eligibility Criteria

Age21 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

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) - 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusettes General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

  • Colling C, Bredella MA, Fazeli PK, Pachon-Pena G, Singh RJ, Rosen CJ, Miller KK. Changes in serum cortisol levels after 10 days of overfeeding and fasting. Am J Physiol Endocrinol Metab. 2023 Jun 1;324(6):E506-E513. doi: 10.1152/ajpendo.00181.2022. Epub 2023 Apr 13.

    PMID: 37053050DERIVED

MeSH Terms

Interventions

Angptl4 protein, mouse

Study Officials

  • Anne Klibanski, MD

    MGH/Harvard Medical School

    PRINCIPAL INVESTIGATOR

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
Chief, Neuroendocrine Unit

Study Record Dates

First Submitted

June 16, 2015

First Posted

June 26, 2015

Study Start

November 1, 2015

Primary Completion

April 1, 2018

Study Completion

April 1, 2018

Last Updated

January 4, 2023

Record last verified: 2022-12

Locations

US(1)