Effect of Age and Weight Loss on Inflammation and Iron Homeostasis
Completed · Not applicable
Conditions studied: Obesity, Aging
In brief
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.
Key facts
- Study ID
- NCT01636635
- Run by
- Tufts University
- People needed
- 44
- Starts
- 2011-03-01
- Expected to finish
- 2013-11-01
- Last updated by the study team
- 2015-11-16
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- JM USDA Human Nutrition Research Center on Aging — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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