ObesityNCT01699906
Diet Induced Weight Loss to Reduce Inflammation in Obese Women
A study testing Diet regimen to induce weight loss in people with Obesity, run by Rockefeller University at 1 site in United States.
Trial summary
Breast cancer is one of the most frequently seen cancers in the United States. It occurs at all ages but is particularly common in post menopausal women. Obesity increases the risk of breast cancer and colon cancer among others, and when cancer develops increases the risk of spread and death. Read more about this study
- Who is it for?
- Ages 40 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Diet regimen to induce weight loss
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to Sep 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 40 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 40-70 years of age
- Post-menopausal women defined as: 24 consecutive months without a menstrual period, currently not taking any medication known to induce amenorhea
- Body Mass Index 35-50
Who cannot join
- History of any bleeding disorder
- HIV positive
- History of previous weight loss surgery.
- History of Inflammatory Bowel Disease
- History of any other malignancy other than non-melanoma skin cancer in the past 5 years
- Currently taking fish oil, omega-3 supplements or other herbal supplements that exceed GRAS (Generally Recognized as Safe) levels
Show all 18Show fewer
- Currently taking any estrogen/progesterone hormones except vaginal cream
- Smokers (or stopped < 3 months ago)
- Currently taking any medication that can alter fat stores as determined by the principal investigator
- Currently taking any weight control medication
- Currently taking hypoglycemic medications.
- Currently taking NSAIDS, aspirin, (if > once a week, stopped <30 days ago). Aspirin 81mg may be permitted if the Framingham Risk Score is < 10
- Currently taking anticoagulant medication or stopped <30 days ago.
- Screening fasting blood glucose >165mg/dL
- Screening thyroid function test abnormal
- Screening LFT results > 2X upper limit of normal
- Screening creatinine > 2X upper limit of normal
- Any condition or situation which, in the opinion of the investigator, puts the patient at significant risk, could complicate the study results, or may interfere significantly with participation in the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Rockefeller University
New York, New York, 10065
About this study
Official title: Diet Induced Weight Loss Reduces Inflammation and Crown-like Structures and Corrects Immune Dysfunction in Subcutaneous Adipose Tissue In Class 2-3 Obese Women: A Pilot Study
Breast cancer is one of the most frequently seen cancers in the United States. It occurs at all ages but is particularly common in post menopausal women. Obesity increases the risk of breast cancer and colon cancer among others, and when cancer develops increases the risk of spread and death. Inflammation of fat tissue, the coronary blood vessels and the liver are also seen with obesity. Animal experiments have shown the inflammation in fat tissue increases the production of estrogen. Thus, reducing inflammation in fat tissue might lower estrogen levels and reduce the risk of breast cancer in obese women as well as the spread of other cancers in the body. Weight reduction in obesity has been shown in epidemiology studies to lower the risk of colon cancer and in obese women to lower the risk of breast cancer. However, how that occurs and how much weight loss is necessary is not known. In mice, calorie restriction in obese animals has been shown to reduce inflammation in fat tissue and the breast. In other studies, calorie reduction has been shown to lower the development of cancer. In addition, we really do not know what starts the whole inflammation process. One good possibility is that immune factors that tend to reduce inflammation are less in obesity. We have shown this in the colon and this also has been suggested as occurring in fat stores.
Read the detailed description
This study aims to determine if weight loss of about 10% of initial weight lowers evidence of inflammation in fat stores. It is likely that, if fat store inflammation is reduced, then inflammation in breast fat also will be lower. Also, it is possible that blood immune cells may be changed with weight loss and even that immune cells in skin will be affected. Since vitamin D has important immune effects and vitamin D is low in obesity, we also want to study what happens to this vitamin during weight loss.
This pilot study of weight loss will be done in 10 very obese post menopausal women. This study will include nutritional and medical evaluation, a 3 day inpatient hospital stay eating a diet providing 50% of what they were taking before starting the study and then a nutritionally adequate diet that will allow them to lose about 10% of their initial weight within 7 to 10 week period. They will have about 4-5 grams of fat removed by suction through a syringe and a biopsy of the skin in addition to studies of blood and stool samples.
When they have completed the study with a 10% body weight loss they will be referred to a nutrition clinic which can counsel them to continue a slower weight loss to an optimal level.
- Conditions
- Obesity
- Being tested
- Diet regimen to induce weight loss
- Keywords
- Obesity
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diet regimen to induce weight lossOther
Also called Very low calorie diet
Diet regimen to induce weight loss
| Study group | Role | What they receive |
|---|---|---|
| Dietary intervention | Experimental | Diet regimen to induce weight loss Receives: Other: Diet regimen to induce weight loss |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adipose tissue inflammation via crown-like structures
Diet-induced weight loss of 10% body weight will result in reduction in abdominal subcutaneous fat inflammation as measured by:
reduction in adipocyte size determined by microscopy and of CLS number in adipose tissue.
reduction in inflammatory gene expression determined by PCR and selected cytokine protein levels.
increased anti-inflammatory lymphocytes determined by immunohistochemistry or by flowcytometry.
Measured: 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2012 (estimated)
- Study startSep 2012
- Primary completionSep 2014
- Study completionSep 2014
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 ObesityStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rockefeller University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter R. Holt, MD, Principal investigator, The Rockefeller University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01699906
- Sponsor's protocol ID
- PHO-0785
- Status last verified
- Jun 2013
- First submitted
- 12 Sep 2012
- Last updated
- 5 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Aleman JO, Bokulich NA, Swann JR, Walker JM, De Rosa JC, Battaglia T, Costabile A, Pechlivanis A, Liang Y, Breslow JL, Blaser MJ, Holt PR. Fecal microbiota and bile acid interactions with systemic and adipose tissue metabolism in diet-induced weight loss of obese postmenopausal women. J Transl Med. 2018 Sep 3;16(1):244. doi: 10.1186/s12967-018-1619-z.
PubMed 30176893
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diet Induced Weight Loss Reduces Inflammation and Crown-like Structures and Corrects Immune Dysfunction in Subcutaneous Adipose Tissue In Class 2-3 Obese Women: A Pilot Study
- ClinicalTrials.gov ID
- NCT01699906
- Acronym / sponsor ID
- PHO-0785
- Conditions
- Obesity
- Keywords
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Rockefeller UniversityUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 4 Oct 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.
Breast cancer is one of the most frequently seen cancers in the United States. It occurs at all ages but is particularly common in post menopausal women. Obesity increases the risk of breast cancer and colon cancer among others, and when cancer develops increases the risk of spread and death. Inflammation of fat tissue, the coronary blood vessels and the liver are also seen with obesity. Animal experiments have shown the inflammation in fat tissue increases the production of estrogen. Thus, reducing inflammation in fat tissue might lower estrogen levels and reduce the risk of breast cancer in obese women as well as the spread of other cancers in the body. Weight reduction in obesity has been shown in epidemiology studies to lower the risk of colon cancer and in obese women to lower the risk of breast cancer. However, how that occurs and how much weight loss is necessary is not known. In mice, calorie restriction in obese animals has been shown to reduce inflammation in fat tissue and the breast. In other studies, calorie reduction has been shown to lower the development of cancer. In addition, we really do not know what starts the whole inflammation process. One good possibility is that immune factors that tend to reduce inflammation are less in obesity. We have shown this in the colon and this also has been suggested as occurring in fat stores.
Detailed description
This study aims to determine if weight loss of about 10% of initial weight lowers evidence of inflammation in fat stores. It is likely that, if fat store inflammation is reduced, then inflammation in breast fat also will be lower. Also, it is possible that blood immune cells may be changed with weight loss and even that immune cells in skin will be affected. Since vitamin D has important immune effects and vitamin D is low in obesity, we also want to study what happens to this vitamin during weight loss.
This pilot study of weight loss will be done in 10 very obese post menopausal women. This study will include nutritional and medical evaluation, a 3 day inpatient hospital stay eating a diet providing 50% of what they were taking before starting the study and then a nutritionally adequate diet that will allow them to lose about 10% of their initial weight within 7 to 10 week period. They will have about 4-5 grams of fat removed by suction through a syringe and a biopsy of the skin in addition to studies of blood and stool samples.
When they have completed the study with a 10% body weight loss they will be referred to a nutrition clinic which can counsel them to continue a slower weight loss to an optimal level.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dietary intervention | Experimental | Other: Diet regimen to induce weight lossDiet regimen to induce weight loss |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 40-70 years of age
- Post-menopausal women defined as: 24 consecutive months without a menstrual period, currently not taking any medication known to induce amenorhea
- Body Mass Index 35-50
Key exclusion criteria (18 listed)
- History of any bleeding disorder
- HIV positive
- History of previous weight loss surgery.
- History of Inflammatory Bowel Disease
- History of any other malignancy other than non-melanoma skin cancer in the past 5 years
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 |
|---|---|---|
| Diet regimen to induce weight lossAlso: Very low calorie dietDiet regimen to induce weight loss | Other | Dietary intervention |
Primary outcome
Adipose tissue inflammation via crown-like structures
Time frame: 9 weeks
Diet-induced weight loss of 10% body weight will result in reduction in abdominal subcutaneous fat inflammation as measured by: reduction in adipocyte size determined by microscopy and of CLS number in adipose tissue. reduction in inflammatory gene expression determined by PCR and selected cytokine protein levels. increased anti-inflammatory lymphocytes determined by immunohistochemistry or by flowcytometry.
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 5 Nov 2014.
- Derived from this study: PubMed 30176893Aleman JO, Bokulich NA, Swann JR, Walker JM, De Rosa JC, Battaglia T, Costabile A, Pechlivanis A, Liang Y, Breslow JL, Blaser MJ, Holt PR. Fecal microbiota and bile acid interactions with systemic and adipose tissue metabolism in diet-induced weight loss of obese postmenopausal women. J Transl Med. 2018 Sep 3;16(1):244. doi: 10.1186/s12967-018-1619-z.
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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.
Peter R. Holt, MD principal investigator
The Rockefeller University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diet regimen to induce weight loss in people with Obesity, run by Rockefeller University 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 3 inclusion and 18 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 5 Nov 2014. 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?
Adipose tissue inflammation via crown-like structures (time frame: 9 weeks). 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 NCT01699906, 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 5 Nov 2014.