Postprandial Inflammatory Response in Healthy Men: Effect of Dietary Fat Source, Obesity and Age
2015年3月24日 更新者：Yves Boirie
The nature of dietary lipids, age and perivisceral adiposity could alter the postprandial inflammatory response. It is supposed that there is a relationship between the postprandial inflammatory response and the repartition of fat and lean mass, which could partially explain the muscle mass loss with age.
The aim of this study is to compare the inflammatory response of a normal meal or high fat meal (from different fatty acids sources) between young lean and young obese and aged lean and aged obese men.
研究概览
地位
完全的
详细说明
32 healthy volunteers will be separated into four groups: 8 young lean men, 8 young obese men, 8 aged lean men and 8 aged obese men.
They will come to the center four times after inclusion, with 2 to 4 weeks wash out each time.
At the first visit they will undergo different test to evaluate their body composition, glucose tolerance, resting energy expenditure, and muscular strength.
At the other three visits, people will undergo a kinetic blood sampling, urine and biopsies of adipose tissue over a period of 8h after ingestion of a test meal.
The different meals tested (Oleic acid vs palmitic acid vs no lipid) will be given in a random way over the three visits.
Before each of these three visits, a controlled diet will be established.
At the last visit body composition and muscular strength will be evaluated.
研究类型
介入性
注册 (实际的)
32
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
-
-
Auvergne
-
Clermont-ferrand、Auvergne、法国、63000
- Human Nutrition Laboratory
-
-
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
20年 至 90年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
男性
描述
Inclusion Criteria:
- Subject giving his written informed consent
- Male from 20 to 35 years old and more than 60
- Affiliated to the French National Health Insurance
- Body mass index (BMI) ≤ 25kg/m² and waist circumference ≤94cm ; or BMI ≥ 28kg/m² and waist circumference ≥ 102cm.
- Complete blood count (CBC)-platelet, normal liver function and normal coagulation.
- Serology of Human immunodeficiency virus (HIV) and hepatitis C virus (HCV) negative
- normal Thyroid Stimulating Hormone(TSH)
Exclusion Criteria:
- Previous medical and/or surgery judged by the investigator as incompatible with this study
- Glaucoma
- C-reactive protein > 10 mg/l
- people over 120 kg
- People with triglyceridemia > 3 g/L or with familial hypercholesterolemia
- Fasting glycemia > 1,26 g/l, abnormal Oral Glucose Tolerance Test
- Dietary habits judged by the dietitian as incompatible with the study aim
- Vegetarians
- Nutritional allergies or xylocaïn allergy
- People with eating disorders
- Heavy consumer of alcohol or cigarette
- Practising intensive physical exercise
- People with medication that could interfere with the measured parameters: beta-blockers, statins, anticoagulants, antiplatelet agents, corticosteroids for more than 8 days.
- Depression or psychiatric treatment
- Being under someone's supervision
- Refusal to be registered on the National Volunteers Data file or refusal to sign the consent form
- Being in exclusion on the National Volunteers Data file
- Blood donation into the last two months preceding the study
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：卫生服务研究
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
安慰剂比较：mashed potatoes
Mashed potatoes is composed of potatoes and Skim milk powder.
|
Mashed potatoes: Potatoes + Skim milk powder
|
|
实验性的：Mashed potatoes + Oleic Acid
The test meal is mashed potatoes with 1g/Kg of weight of lipids with 75% of Oleic Acid
|
Mashed potatoes with 1g/Kg of weight, of lipids with 75% of Oleic Acid
|
|
实验性的：Mashed potatoes + Palmitic Acid
The test meal is mashed potatoes with 1g/Kg of weight of lipids with 39% of saturated fat with 32% of palmitic acid.
|
Mashed potatoes with 1g/Kg of weight, of lipids with 32% of palmitic acid
|
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Inflammatory profile by interleukin-6 (IL6) concentration in plasma.
大体时间：six times per day (kinetic: T0 to T480) on three interventional days
|
six times per day (kinetic: T0 to T480) on three interventional days
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Muscular strength, Body composition
大体时间：Once at the first and at the last visit
|
Once at the first and at the last visit
|
|
Total plasma lipids (total cholesterol, HDL-Cholesterol, LDL-cholesterol, Triglycerides (TG), non-esterified fatty acid, Plasma hormonal profile, Plasma inflammatory profile, Markers of Endothelial function, Plasma lipopolysaccharide concentration.
大体时间：Six times per day (kinetic: T0 to T480), on three interventional days
|
Six times per day (kinetic: T0 to T480), on three interventional days
|
|
Pro-inflammatory cytokines expression in subcutaneous adipose tissue
大体时间：Twice per day (before the meal and 6 hours after), on three interventional days
|
Twice per day (before the meal and 6 hours after), on three interventional days
|
|
Urinary metabolomic profile
大体时间：Three times per days (T0,T240,T480), on three interventional days
|
Three times per days (T0,T240,T480), on three interventional days
|
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。
赞助
调查人员
- 首席研究员：Yves Boirie, MD/PhD、CRNH
- 研究主任：Stephane Walrand, PhD、Institut National de la Recherche Agronomique
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
有用的网址
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
2010年3月1日
初级完成 (实际的)
2010年12月1日
研究完成 (实际的)
2011年1月1日
研究注册日期
首次提交
2010年2月9日
首先提交符合 QC 标准的
2010年2月9日
首次发布 (估计)
2010年2月10日
研究记录更新
最后更新发布 (估计)
2015年3月25日
上次提交的符合 QC 标准的更新
2015年3月24日
最后验证
2011年1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.