Effect of Nutritional Interventions on Inflammatory Status in Healthy Overweight Men
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- inflammation parameters
研究概览
简要总结
In the present study it is hypothesized that a reduction of the inflammatory status may prevent the occurrence of disorders and diseases related to overweight.
In this study the effects of nutritional compounds will be studied in overweight men with a low grade inflammatory status. We will investigate the effects of 3 different food treatments as compared to a placebo on markers of inflammation and on parameters of glucose and fat metabolism. The three different food treatments are a food mix and two yogurts each containing different probiotic strains. The food mix is composed of a mix of nutritional components, each reported to affect inflammation parameters and (or) anti-oxidant status but different in their -hypothesized-mode of action.
详细描述
From day -01 onwards until the end of the study, subjects will come to TNO every week. Each of the four study periods will be performed identically.
In the first study period, on days -01, 07, 14, 21 and 28, subjects will come to TNO for collection of study substances for the coming week. On days 14, 21 and 28 they will come in a fasting state in the morning for blood sampling (fasting). Fasting blood samples will be taken by venapuncture.
After having received new study substances and the diary for the coming week, subjects can leave TNO.
On day 34, subjects will come to TNO at around 8:00 am and they will stay at TNO till about 11:00 for an oral glucose tolerance test. Fasting blood samples will be collected for determining treatment parameters. Subsequently subjects are provided the oral glucose load of 75 g glucose dissolved in 300 ml water. Blood samples will be taken at t= 90 and 120 min after the glucose load. After the last sample of the OGTT has been collected, subjects will be asked to void their bladder and afterwards receive a bottle for collection of 24 hour urine. The subjects will receive a free breakfast and can leave TNO.
The next day, on Day 35, subjects consume the breakfast as provided by TNO at home at around 8:00.They will come to TNO at around 11:00 am and they will stay at TNO till about 20:00. In addition, they will turn in the urine bottle after having voided their bladder at 24 after start of collection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy as assessed by the Health and lifestyle questionnaire Physical examination. Results of the pre-study laboratory tests
- •Males aged over 18 and < 60 years at Day 01 of the study
- •Body Mass Index (BMI): 26 - 35 (including) kg/m2
- •C-reactive protein (CRP) 1-10 mg/L. Acute inflammation as reason for increased CRP to be excluded based on white blood cell counts
- •Willing to use the study substances (yogurt and capsules) daily for 20 weeks
- •Normal Dutch eating habits as assessed by questionnaire
- •Voluntary participation and having given written informed consent
- •Willing to comply with the study procedures, including no use of food supplements, probiotic containing products and NSAID
- •Willing not to serve as blood donor during the study
- •Willing to accept use of all nameless data, including publication, and the confidential use and storage of all data
- •Willing to accept the disclosure of the financial benefit of participation in the study to the authorities concerned
排除标准
- •Participation in any clinical trial including blood sampling and/or administration of substances up to 90 days before Day 01 of this study
- •Participation in any non-invasive clinical trial up to 30 days before Day 01 of this study, including no blood sampling and/or oral, intravenous, inhalatory administration of substances
- •Having a chronic disease related to inflammation (such as arthritis) or a history of medical or surgical events that may significantly affect the study outcome, including diabetes (type 1 or 2) cardiovascular disease and hypothyroidemy
- •High blood pressure (age <55 y: DBP > 100 or SBP >160 mm Hg, age 55-59: DBP > 90 or SBP >140 mm Hg)
- •Fasting blood glucose level >6.9 mmol/L
- •Fasting cholesterol > 8 mmol/L
- •Blood hemoglobin < 8 mmol/L
- •Use of medication that might interfere with parameters to be measured or with one of the treatments
- •Frequent use of antibiotic medication (3 times or more in the past year)*
- •Frequent use of NSAID or paracetamol (frequency and/or urgency of need incompatible with participation - to be decided by medical investigator)
- •Lactose intolerance
- •Extreme physical exercise > 6 hours/week
- •Reported unexplained weight loss or gain of > 4 kg in the month prior to the pre-study screening
- •Alcohol consumption > 28 units per week
- •Reported slimming or medically prescribed diet
- •Recent blood donation (< 1 month prior to the start of the study)
- •Personnel of TNO Quality of Life, their partner and their relatives in the first and second remove
- •Not having a general practitioner
- •Not willing to accept information transfer concerning participation in the study, or information regarding his health, like laboratory results, findings at anamnesis or physical examination and eventual adverse events to and from his general practitioner
结局指标
主要结局
inflammation parameters
时间窗: 5 weeks
次要结局
- glucose and fat response(5 weeks)