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Diet Induced Weight Loss to Reduce Inflammation in Obese Women

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Diet regimen to induce weight loss
Sponsored by
Rockefeller University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Obesity focused on measuring Obesity

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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.

Sites / Locations

  • The Rockefeller University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Dietary intervention

Arm Description

Diet regimen to induce weight loss

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
September 12, 2012
Last Updated
November 4, 2014
Sponsor
Rockefeller University
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1. Study Identification

Unique Protocol Identification Number
NCT01699906
Brief Title
Diet Induced Weight Loss to Reduce Inflammation in Obese Women
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rockefeller University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Obesity

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dietary intervention
Arm Type
Experimental
Arm Description
Diet regimen to induce weight loss
Intervention Type
Other
Intervention Name(s)
Diet regimen to induce weight loss
Other Intervention Name(s)
Very low calorie diet
Intervention Description
Diet regimen to induce weight loss
Primary Outcome Measure Information:
Title
Adipose tissue inflammation via crown-like structures
Description
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.
Time Frame
9 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter R. Holt, MD
Organizational Affiliation
The Rockefeller University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Rockefeller University
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
30176893
Citation
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.
Results Reference
derived

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Diet Induced Weight Loss to Reduce Inflammation in Obese Women

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