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Effect of Age and Weight Loss on Inflammation and Iron Homeostasis (HEP)

This study is currently recruiting participants.
Verified July 2012 by Tufts University
Sponsor:
Information provided by (Responsible Party):
Simin Meydani, Tufts University
ClinicalTrials.gov Identifier:
NCT01636635
First received: January 26, 2012
Last updated: July 5, 2012
Last verified: July 2012
History of Changes
  Purpose

The purpose of this study is to evaluate the effect of aging and weight loss on iron status and immune response in obese women. Iron deficiency and immune impairment are two of the numerous complications of obesity. The central hypothesis is that obesity-induced inflammation causes lower iron status through decreased iron absorption and availability in young and older obese women. Furthermore, the investigators hypothesize that this can be corrected with weight loss in both young and older obese women.


Condition Intervention
Obese Women With BMI Between 30 and 55 kg/m2
 Other: Calorie Restriction

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Effect of Age and Weight Loss on Obesity-related Inflammation and Iron Homeostasis in Women

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Tufts University:

Primary Outcome Measures:
  • Change in serum hepcidin [ Time Frame: Baseline and 12-16 weeks ] [ Designated as safety issue: No ]
    The investigators will determine the change in hepcidin at baseline and after 12-16 weeks of calorie restriction.

  • Change in inflammation (CRP, IL-6) [ Time Frame: Baseline and 12-16 weeks ] [ Designated as safety issue: No ]
    The investigators will determine the change in inflammation at baseline and after 12-16 weeks of calorie restriction.

  • Change in iron status [ Time Frame: Baseline and 12-16 weeks ] [ Designated as safety issue: No ]
    The investigators will determine the change in iron status at baseline and after 12-16 weeks of calorie restriction.


Secondary Outcome Measures:
  • Change in PBMC intracellular iron content [ Time Frame: Baseline and 12-16 weeks ] [ Designated as safety issue: No ]
  • Change in PBMC Hepcidin expression [ Time Frame: Baseline and 12-16 weeks ] [ Designated as safety issue: No ]
  • Change in PBMC ferroportin expression [ Time Frame: Baseline and 12-16 weeks ] [ Designated as safety issue: No ]
  • Change in PBMC proliferation [ Time Frame: Baseline and 12-16 weeks ] [ Designated as safety issue: No ]
    After stimulation with ConA, PHA and anti-CD3/CD28


Estimated Enrollment: 46
Study Start Date: March 2011
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Young (18-45 years) Other: Calorie Restriction
Intervention consists of a calorically restricted diet regime designed and administered at the Weight and Wellness Center at Tufts University
Experimental: Older (>60 years) Other: Calorie Restriction
Intervention consists of a calorically restricted diet regime designed and administered at the Weight and Wellness Center at Tufts University

Detailed Description:

Obese individuals have chronic inflammation, higher risk of iron deficiency, and impaired immune response. These are conditions seen also with aging, but it is unknown to what extent they may be further impacted by obesity in the elderly. With this study the investigators aim to establish the mechanism by which weight loss may reduce inflammation and enhance iron status in young and older obese adults through the peptide hormone hepcidin, which regulates iron homeostasis. The investigators also aim to identify a possible link between iron homeostasis and immune response through hepcidin, which has been implicated in T cell mediated immunity. The investigators hypothesize that obesity-induced inflammation causes dysregulation of hepcidin expression leading to lower iron status through decreased iron absorption and availability in young and older adults. Furthermore, the investigators hypothesize that hepcidin dysregulation, and thus iron status can be mitigated with weight loss in both young and older obese adults. This hypothesis will be tested in obese young and older women undergoing weight loss through calorie restriction. Change in iron status, inflammation, and hepcidin will be determined before and after weight loss. Further, the impact of inflammatory environment of obesity on peripheral blood mononuclear cell hepcidin, ferroportin, intracellular iron, and T cell function in young and older adults will be determined. This study will address two important public health problems, i.e. obesity and iron deficiency and will be an important step toward the identification of strategies to enhance health of obese young and older adults.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Enrolling patients in the Weight and Wellness Center (WWC) at Tufts Medical Center, part of their Tufts Employees, low calorie diet (LCD) or pre-surgical low calorie diet (PS-LCD) program, or enrolling at WWC as individual patients.
  • BMI in the range of 30 to 55 kg/m2.
  • Either ages 18-45 or >60.

Exclusion Criteria:

  • Pregnancy.
  • Weight reduction greater than or equal to 3% in the past 3 months.
  • Prior gastric restrictive surgery.
  • Weight loss medications within the 4 weeks prior to screening.
  • History of eating disorder.
  • Renal disease (serum creatinine >2mg/dl).
  • Hepatic disease, except for nonalcoholic steatohepatitis (NASH).
  • Celiac disease, or any kind of intestinal malabsorption disorders.
  • Gastrointestinal cancer.
  • Hereditary hemochromatosis, or any blood disorders.
  • Chronic infectious or inflammatory disease.
  • Use of immunosuppressants.
  • Severe iron deficiency anemia (hemoglobin<8 g/dl) or other conditions that would prevent them from discontinuing iron supplement use.
  • Unwilling to discontinue iron supplement intake. The dietary plan recommended by the WWC will include daily intake of iron that meets the iron RDA for the subject's gender and age group, therefore discontinuing iron supplement will not be harmful for the participants. Intake of other supplements will not be an exclusion criteria, as long as it stays constant throughout the study period.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01636635

Contacts
Contact: Simin N Meydani, PhD, DVM 617-556-3129 simin.meydani@tufts.edu
Contact: Maria C Dao, MS 617-556-3233 carlota.dao@tufts.edu

Locations
United States, Massachusetts
JM USDA Human Nutrition Research Center on Aging Recruiting
Boston, Massachusetts, United States, 02111
Contact: Simin N Meydani, DVM, PhD     617-556-3129     simin.meydani@tufts.edu    
Contact: Maria C Dao, MS     617-556-3233     carlota.dao@tufts.edu    
Sponsors and Collaborators
Tufts University
Investigators
Principal Investigator: Simin N Meydani, DVM, PhD Tufts University
  More Information

Additional Information:
JM USDA HNRCA main website  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Simin Meydani, Simin Meydani, DVM, PhD, Tufts University
ClinicalTrials.gov Identifier: NCT01636635     History of Changes
Other Study ID Numbers: 2765
Study First Received: January 26, 2012
Last Updated: July 5, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Inflammation
Weight Loss
Pathologic Processes
 Body Weight Changes
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 21, 2013