Metabolic Risk Markers and Body Weight Are Decreased by Green-plant Supplementation in a Pilot Study With Overweight-to-obese Middle-aged Men.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Region Skane
- 入组人数
- 20
- 主要终点
- Body weight
研究概览
简要总结
Objective:
The purpose of this study was to investigate the possible effects of green-plant thylakoid supplementation to a restricted diet intervention study in overweight to obese men.
Methods:
Overweight-obese men (BMI 25 - 35) were treated to a 30 E% restricted diet for one month, followed by one month of stabilization. Then they were divided in two treatment arms of one month each; one thylakoid-enriched diet (n=10) and one control diet (n=10). Body measurements and blood samples were taken throughout the study.
详细描述
Twenty healthy, non-vegetarian, non-smoking Caucasian men were included in the study. Inclusion criteria: men aged 40 to 70 years with a BMI of 25 to 35. Exclusion criteria: Metabolic disturbances, bariatric surgery, recent diet, food allergies or treatment with antibiotics. The study protocol was approved by the Ethical Committee of Lund University, Sweden (#2006/361).
The trial consisted of three periods: 1) diet-restriction period (one month) 2) stabilizing period (one month) 3) diet-restriction period with supplementation of thylakoids or placebo (one month). The two weight-losing periods included strict diet recommendation with -30 energy % (E%), and macronutrient composition: 55-65 E% carbohydrates, 10-15 E% protein and 25-35 E% fat. Sixty minutes of low intensive exercise per day was also required.
During the stabilizing month participants were instructed to eat a healthy diet to be able to keep their achieved weight-loss.
Day 0, 28, 56 and 84 the participants arrived after 12-hour fasting for blood sampling and anthropometric measurements. The blood samples were analyzed for plasma-glucose, insulin, HbA1c, inflammation markers, cholecystokinin, ghrelin, total cholesterol, LDL-cholesterol, HDL-cholesterol, and triacylglycerol.
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
- Single (Participant)
入排标准
- 年龄范围
- 40 Years 至 70 Years(Adult, Older Adult)
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy, overweight, non-vegetarian, non-smoking
排除标准
- •Medication for metabolic disturbances, previous bariatric surgery, diabetes, had been on diet or treated with antibiotics during last 3 months, food-allergies
研究组 & 干预措施
Control group
Control group subjects received the same diet restriction intervention as treatment group. However, their food products did not contain any active component.
干预措施: Control (Other)
Thylakoid group
Thylakoid group subjects received the same diet restriction intervention as the control group. However, their food products did contain an active component in the form of thylakoid powder.
干预措施: Thylakoids (Dietary Supplement)
结局指标
主要结局
Body weight
时间窗: 3 months
次要结局
- Blood lipids(3 months)
- Inflammatory markers(3 months)
- Appetite regulating hormones(3 months)
- Waist circumference(3 months)
- P-glucose and p-insulin(3 months)
