Effect of Age and Weight Loss on Inflammation and Iron Homeostasis (HEP)
2015年11月12日 更新者:Simin Meydani、Tufts University
Effect of Age and Weight Loss on Obesity-related Inflammation and Iron Homeostasis in Women
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.
研究概览
详细说明
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.
研究类型
介入性
注册 (实际的)
44
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
-
-
Massachusetts
-
Boston、Massachusetts、美国、02111
- JM USDA Human Nutrition Research Center on Aging
-
-
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
女性
描述
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.
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:基础科学
- 分配:非随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器:Young (18-45 years)
Obese young women (18-45y) undergoing calorie restriction.
|
Intervention consists of a calorically restricted diet regime designed and administered at the Weight and Wellness Center at Tufts University
|
|
实验性的:Older (>60 years)
Obese older women (>60y) undergoing calorie restriction.
|
Intervention consists of a calorically restricted diet regime designed and administered at the Weight and Wellness Center at Tufts University
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in serum hepcidin
大体时间:Baseline and 12-16 weeks
|
The investigators will determine the change in hepcidin at baseline and after 12-16 weeks of calorie restriction.
|
Baseline and 12-16 weeks
|
|
Change in inflammation (CRP, IL-6)
大体时间:Baseline and 12-16 weeks
|
The investigators will determine the change in inflammation at baseline and after 12-16 weeks of calorie restriction.
|
Baseline and 12-16 weeks
|
|
Change in iron status
大体时间:Baseline and 12-16 weeks
|
The investigators will determine the change in iron status at baseline and after 12-16 weeks of calorie restriction.
|
Baseline and 12-16 weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in PBMC intracellular iron content
大体时间:Baseline and 12-16 weeks
|
Baseline and 12-16 weeks
|
|
|
Change in PBMC Hepcidin expression
大体时间:Baseline and 12-16 weeks
|
Baseline and 12-16 weeks
|
|
|
Change in PBMC ferroportin expression
大体时间:Baseline and 12-16 weeks
|
Baseline and 12-16 weeks
|
|
|
Change in PBMC subpopulations and proliferation
大体时间:Baseline and 12-16 weeks
|
After stimulation with ConA, PHA and anti-CD3/CD28
|
Baseline and 12-16 weeks
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Simin N Meydani, DVM, PhD、Tufts University
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2011年3月1日
初级完成 (实际的)
2013年11月1日
研究完成 (实际的)
2013年11月1日
研究注册日期
首次提交
2012年1月26日
首先提交符合 QC 标准的
2012年7月5日
首次发布 (估计)
2012年7月10日
研究记录更新
最后更新发布 (估计)
2015年11月16日
上次提交的符合 QC 标准的更新
2015年11月12日
最后验证
2015年11月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.