HealthyNCT01658397
The Effect of Calorie Deprivation on Adipose Tissue Distribution
A study testing Fasting in people with Healthy, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. 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?
- Fasting
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to 21 Jul 2014
- 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
- 101-130% 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
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
- Pregnant and/or breastfeeding (women)
- Diabetes mellitus
- Active substance abuse, including alcohol
- Contraindications to MRI: cardiac pacemaker, metal implants, claustrophobia
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
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.
- Conditions
- Healthy
- Being tested
- Fasting
- Keywords
- Healthy subjects, Fasting, Weight loss
- Medical subject headings
- Fasting, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FastingBehavioural
Ten day fast
| Study group | Role | What they receive |
|---|---|---|
| Fasting | Experimental | Ten day fast Receives: Behavioral: Fasting |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, After 10 day fasting period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2012 (estimated)
- Study startSep 2012
- Primary completion21 Jul 2014
- Study completion21 Jul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pouneh K. Fazeli, MD, Massachusetts General Hospital
- Investigators
- Pouneh K Fazeli, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01658397
- Sponsor's protocol ID
- 2010P001066
- Status last verified
- Feb 2017
- First submitted
- 1 Aug 2012
- Last updated
- 10 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Calorie Deprivation on Adipose Tissue Distribution
- ClinicalTrials.gov ID
- NCT01658397
- Acronym / sponsor ID
- 2010P001066
- Conditions
- Healthy
- Keywords
- Healthy subjects, Fasting, Weight loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- 21 Jul 2014 (actual)
- Study completion
- 21 Jul 2014 (actual)
- First posted
- 7 Aug 2012 (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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fasting | Experimental | Behavioral: FastingTen 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
- 101-130% 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
Key exclusion criteria (7 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
- Pregnant and/or breastfeeding (women)
- Diabetes mellitus
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 |
|---|---|---|
| FastingTen day fast | Behavioural | Fasting |
Primary outcome
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.
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 10 Feb 2017.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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.
Pouneh K Fazeli, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 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 7 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 10 Feb 2017. 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?
Change in Bone Marrow Adiposity over 10 day fasting period (time frame: Baseline, After 10 day fasting period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Feb 2017.