The Effect of an Anti-Inflammatory Diet on Weight Loss, Body Composition, Cardiometabolic Risk Factors and Immune System Response in Younger Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 220
- 试验地点
- 2
- 主要终点
- The changes in the body mass index
研究概览
简要总结
Diet has a major role in the etiology of obesity, and there is a growing body of evidence suggesting that a variety of dietary factors can modulate obesity-induced chronic low-grade inflammation and thus the course of obesity-related chronic non-communicable diseases. The present intervention study aims to evaluate the effect of an anti-inflammatory diet on weight loss, body composition, cardiometabolic risk factors and immune system response among young adults of the obese younger adults.
详细描述
Obesity pandemic presents a major challenge to chronic disease prevention worldwide. A low-grade chronic inflammation is associated with obesity and related cardiometabolic disorders, such as cardiovascular diseases, type 2 diabetes and some type of cancers. Diet has a major role in the etiology of obesity, and there is a growing body of evidence suggesting that a variety of dietary factors can modulate obesity-induced chronic low-grade inflammation and thus the course of obesity-related chronic non-communicable diseases. The present intervention study aims to evaluate the effect of an anti-Inflammatory diet on weight loss, body composition, cardiometabolic risk factors and immune system response among younger adults. A nutritional intervention based on an energy-restricted anti-inflammatory diet will be compared with an isocaloric standard diet (55-60% carbohydrates, 25% fat, 15-20% protein). The inflammatory potential of the diet will be assessed with the Dietary Inflammatory Index®.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •adults age of 18 to 50 years
- •body mass index ≥ 30 kg/m2
- •with or without obesity related complications
排除标准
- •chronic hearth, renal and/or liver diseases,
- •active carcinoma or having carcinoma in last year
- •anti-inflammatory and/or immunosuppressive drugs intake
- •changing the existing medication therapy
- •persons older than 50 years
- •active infection and/or surgical procedure in last 3 months
- •nutritive allergy or intolerance to any anti-inflammatory diet constituent
- •pregnancy
结局指标
主要结局
The changes in the body mass index
时间窗: baseline, follow up 6 months
body mass index (kg/m2) calculated from measured body weight (kg) and height (m)
The changes of fat mass
时间窗: baseline, follow up 6 months
fat mass (kg) measured with bioelectric impedance analyzer
The changes in the waist circumference
时间窗: baseline, follow up 6 months
waist circumference (cm) measured with measuring tape
The changes of visceral adipose tissue
时间窗: baseline, follow up 6 months
visceral adipose tissue (l) measured with bioelectric impedance analyzer
The changes of skeletal muscle mass
时间窗: baseline, follow up 6 months
skeletal muscle mass (kg) measured with bioelectric impedance analyzer
The changes of fat-free mass
时间窗: baseline, follow up 6 months
fat-free mass (kg) measured with bioelectric impedance analyzer
次要结局
- The changes in free tri-iodothyronine (fT3) concentration(baseline, follow up 6 months)
- The changes in serum lipid profile(baseline, follow up 6 months)
- The changes in serum liver transaminases concentration(baseline, follow up 6 months)
- The changes in insulin concentration(baseline, follow up 6 months)
- The changes of HOMA-index(baseline, follow up 6 months)
- The changes in fasting glucose concentration(baseline, follow up 6 months)
- The changes in HbA1c concentration(baseline, follow up 6 months)
- The changes in serum IL-beta, IL-6 and TNF-alpha concentrations(baseline, follow up 6 months)
- The changes in serum hs-C-reactive protein concentration(baseline, follow up 6 months)
- The changes of blood lymphocytes T and lymphocite subgroups count(baseline, follow up 6 months)
- The changes in thyroid stimulating hormone (TSH) concentration(baseline, follow up 6 months)
- The changes in free thyroxine (fT4) concentration(baseline, follow up 6 months)
- The changes in thyroid peroxidase antibodies (TPOAbs) concentration(baseline, follow up 6 months)
研究者
Sanja Klobučar Majanović
Assistant Professor
Clinical Hospital Center Rijeka