Matrix Characterization and Effects of Fermented Dairy Products on Liver Fat, Cardiometabolic Risk and Gut Microbiome in Males With Symptoms of Metabolic Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Liver fat
研究概览
简要总结
The study will be conducted as a randomized controlled trial with four parallel arms including four dairy products. We will investigate the health effects of including yogurt in the diet through a 16-weeks intervention period among 100 volunteering males with symptoms of the metabolic syndrome. The study has a total duration of 20 weeks as a wash out period of four weeks will be initiated prior to the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Until the statistical analyses are performed, principal investigator and statistician are blinded
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Age between 30-70 years
- •BMI of 28-45 kg/m2
- •Abdominal obesity (defined as waist circumference >102 cm)
- •Provided voluntary written informed consent
排除标准
- •Body weight changes +/- 5% in the past three months
- •Any diet, allergy or intolerance which results in not being able to follow the study protocol
- •Contraindications related to MRI (pacemaker, stent, magnitic metal in the body, claustrophobia, physiological diseases or a body weight >160 kg)
- •History or diagnosis of diabetes
- •History or diagnosis of heart, liver, gastrointestinal or kidney disease
- •History or diagnosis of illness related to energy balance
- •History or diagnosis of eating disorders
- •Simultaneous blood donation for other purpose than this study (and one month before initiating the study)
- •Simultaneous participation in other clinical intervention studies
- •Any other condition that judged by the investgator may interfere with the adherence to the study protocol
研究组 & 干预措施
Regular whole milk
Substitution of a part of the habitual diet with 400 g/day of regular whole milk
干预措施: Regular whole milk (Dietary Supplement)
Yogurt with live bacteria
Substitution of a part of the habitual diet with 400 g/day of yogurt with life bacteria
干预措施: Yogurt with live bacteria (Dietary Supplement)
Yogurt with inactivated bacteria
Substitution of a part of the habitual diet with 400 g/day of yogurt with inactivated bacteria
干预措施: Yogurt with inactivated bacteria (Dietary Supplement)
Acidified whole milk
Substitution of a part of the habitual diet with 400 g/day of acidified whole milk
干预措施: Acidified whole milk (Dietary Supplement)
结局指标
主要结局
Liver fat
时间窗: Change from Week 0 to week 16
Measurements of liver fat by Magnetic Resonance Imaging
次要结局
- Glucose metabolism (fasting samples)(Change from Week 0 to week 16)
- Cardiometabolic risk(Change from Week 0 to week 16)
- Inflammation(Change from Week 0 to week 16)
- Gut microbiome(Change from week -4 to week 16)
- Glucose metabolism (5 hour oral glucose tolerance test)(Week 16 (5 hour test))
- Body composition(Change from week -4 to week 16)
- Fat disposition and pancreatic fat(Change from Week 0 to week 16)
研究者
Faidon Magkos
Professor
University of Copenhagen