HealthyNCT02482519
The Effects of Acute Weight Gain and Acute Calorie Deprivation on Marrow Adipose Tissue
A study testing High calorie diet and Fasting in people with Healthy, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- High calorie diet and Fasting
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2015to Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusettes General Hospital
Boston, Massachusetts, 02114
About this study
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.
Read the detailed description
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. Studies have shown that nutritional status, particularly body fat distribution, may be important in marrow fat. For example, anorexia nervosa, a state of low body fat, is associated with elevated marrow adiposity and low bone mineral density. However, it is not known whether this is in direct response to nutritional deprivation or other hormonal changes that occur in anorexia nervosa. Drugs known to cause adipose redistribution and associated with low bone mass, such as the thiazolidinediones and glucocorticoids, have also been shown to stimulate the accumulation of marrow adipocytes. Therefore, the relationship between bone marrow fat, bone mass, body fat depots and their hormone regulators is a dynamic one and not yet well understood. Although studies have shown an inverse relationship between high marrow adiposity and low bone mineral density (BMD), the physiologic role of marrow adipose tissue has not been defined nor its relationship to hormonal factors in humans. A role for marrow adipose tissue (MAT) in mineral and energy metabolism is further supported by the fact that a number of pathologic states are associated with increased marrow adiposity. Visceral adipose tissue, intramyocellular lipids (IMCL), intrahepatic lipids (IHL) and serum triglycerides, all of which are elevated in obesity, are also positive predictors of MAT, but whether acute weight gain in humans results in elevated marrow adiposity is unknown. Therefore observing changes in marrow fat during acute weight gain and acute nutritional deprivation will further the understanding of the role of marrow adiposity in energy homeostasis. While it is known that markers of bone formation dramatically decrease after only 4 days of fasting, it is not known how quickly marrow fat can change in response to physiologic cues. In a rat model, increases in marrow fat were observed after 14 days in space suggesting that changes in marrow adiposity may occur acutely in the human model as well.
- Conditions
- Healthy
- Being tested
- High calorie diet, Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High calorie dietOther
High calorie diet for 10 days
FastingOther
10 day fast
| Study group | Role | What they receive |
|---|---|---|
| 10 day overfeeding/fasting | Other | 10 day high calorie diet followed by a 10 day fast Receives: Other: High calorie diet; Other: Fasting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Marrow adiposity will be measured using magnetic resonance spectroscopy
Marrow adipose tissue measurement of the spine and hip
Measured: Change from baseline marrow adipose tissue after high-calorie diet and after fast (35 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2015 (estimated)
- Study startNov 2015
- Primary completionApr 2018
- Study completionApr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karen Klahr Miller, MD, Massachusetts General Hospital
- Investigators
- Anne Klibanski, MD, Principal investigator, MGH/Harvard Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02482519
- Sponsor's protocol ID
- 2015P000624
- Status last verified
- Dec 2022
- First submitted
- 16 Jun 2015
- Last updated
- 4 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 37053050
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Acute Weight Gain and Acute Calorie Deprivation on Marrow Adipose Tissue
- ClinicalTrials.gov ID
- NCT02482519
- Acronym / sponsor ID
- 2015P000624
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Apr 2018 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 26 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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. Studies have shown that nutritional status, particularly body fat distribution, may be important in marrow fat. For example, anorexia nervosa, a state of low body fat, is associated with elevated marrow adiposity and low bone mineral density. However, it is not known whether this is in direct response to nutritional deprivation or other hormonal changes that occur in anorexia nervosa. Drugs known to cause adipose redistribution and associated with low bone mass, such as the thiazolidinediones and glucocorticoids, have also been shown to stimulate the accumulation of marrow adipocytes. Therefore, the relationship between bone marrow fat, bone mass, body fat depots and their hormone regulators is a dynamic one and not yet well understood. Although studies have shown an inverse relationship between high marrow adiposity and low bone mineral density (BMD), the physiologic role of marrow adipose tissue has not been defined nor its relationship to hormonal factors in humans. A role for marrow adipose tissue (MAT) in mineral and energy metabolism is further supported by the fact that a number of pathologic states are associated with increased marrow adiposity. Visceral adipose tissue, intramyocellular lipids (IMCL), intrahepatic lipids (IHL) and serum triglycerides, all of which are elevated in obesity, are also positive predictors of MAT, but whether acute weight gain in humans results in elevated marrow adiposity is unknown. Therefore observing changes in marrow fat during acute weight gain and acute nutritional deprivation will further the understanding of the role of marrow adiposity in energy homeostasis. While it is known that markers of bone formation dramatically decrease after only 4 days of fasting, it is not known how quickly marrow fat can change in response to physiologic cues. In a rat model, increases in marrow fat were observed after 14 days in space suggesting that changes in marrow adiposity may occur acutely in the human model as well.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 10 day overfeeding/fasting | Other | Other: High calorie diet, Other: Fasting10 day high calorie diet followed by a 10 day fast |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High calorie dietHigh calorie diet for 10 days | Other | 10 day overfeeding/fasting |
| Fasting10 day fast | Other | 10 day overfeeding/fasting |
Primary outcome
Marrow adiposity will be measured using magnetic resonance spectroscopy
Time frame: Change from baseline marrow adipose tissue after high-calorie diet and after fast (35 days)
Marrow adipose tissue measurement of the spine and hip
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2023.
- Derived from this study: PubMed 37053050Colling 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne Klibanski, MD principal investigator
MGH/Harvard Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High calorie diet and Fasting in people with Healthy, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Marrow adiposity will be measured using magnetic resonance spectroscopy (time frame: Change from baseline marrow adipose tissue after high-calorie diet and after fast (35 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02482519, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2023; AzTrials last refreshed its copy on 8 Nov 2026.