Diet Induced Weight Loss to Reduce Inflammation in Obese Women

NCT01699906 | Completed

• 1 other identifier: PHO-0785
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

Obesity

Outcome Measures

Primary Outcomes (1)

• 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.

  9 weeks

Study Arms (1)

Dietary intervention

EXPERIMENTAL

Diet regimen to induce weight loss

Other: Diet regimen to induce weight loss

Interventions

Diet regimen to induce weight loss OTHER

Diet regimen to induce weight loss

Also known as: Very low calorie diet

Dietary intervention

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rockefeller University: lead

Study Sites (1)

The Rockefeller University

New York, New York, 10065, United States

Location

Related Publications (1)

• 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.

  PMID: 30176893 DERIVED

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Peter R. Holt, MD

  The Rockefeller University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2012
• First Posted: October 4, 2012
• Study Start: September 1, 2012
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: November 5, 2014

Record last verified: 2013-06

Locations

US (1)