跳至主要内容
临床试验/NCT02687295
NCT02687295已完成不适用

Metabolic Risk Markers and Body Weight Are Decreased by Green-plant Supplementation in a Pilot Study With Overweight-to-obese Middle-aged Men.

Region Skane0 个研究点目标入组 20 人开始时间: 2010年1月1日最近更新:
适应症
干预措施

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

Placebo Comparator

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

Active Comparator

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)

研究者

发起方
Region Skane
申办方类型
Other
责任方
Principal Investigator
主要研究者

Eva-Lena Stenblom

M.D.

Region Skane

相似试验