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临床试验/NCT02993627
NCT02993627已完成不适用

Effects of Spirulina Supplementation on Anthropometric Measurements, Lipid Profile, Appetite, Liver Enzymes, Inflammatory and Glycemic Markers on Overweight or Obese Adults

Shahid Beheshti University of Medical Sciences2 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2016年12月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
52
试验地点
2
主要终点
waist/hip ratio

研究概览

简要总结

In this double-blind Randomized Controlled Clinical Trial investigators are going to study the effects of Spirulina supplementation on anthropometric measurements, lipid profile, appetite, liver enzymes, inflammatory and glycemic markers in a sample of overweight or obese adults.

详细描述

A sample of 40 obese and overweight subjects will be recruited from Nutrition And Diet Therapy Clinic Of Shahid Beheshti Medical University.

This study is a double-blind Randomized Controlled Clinical Trial, that subjects will be randomly allocated to spirulina or placebo group according to the Random permuted blocks within strata method based on BMI. Subjects will consume 2 g spirulina daily (4 tablets of 500mg), whereas the control group are going to receive identical placebo tablets. Subjects are asked to maintain their usual physical activity level during the intervention period and also avoid taking any other supplements or medications without consulting the investigators. Intervention period is designed to be 12 weeks that has been determined sufficient to record changes of study parameters. At the beginning of the study and after 12 weeks of intervention, morning blood samples will be collected after 12 h of fasting. Anthropometric parameters will be also measured at the beginning, week 6 and after 12 weeks of intervention. Subjects will be followed through social network to ensure their compliance with the study. Furthermore, subjects in both spirulina and placebo groups received low calorie diet (-500 or -300 kcal) composed of 55% carbohydrate, 15% protein and 30% fat during the study period.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • BMI>25 kg/m2
  • No history of medications for obesity, diabetes, dyslipidemia, inflammatory disease within 3 months before the study
  • No history of vitamin or antioxidant supplementation within 3 months before the study
  • Giving written informed consent for participation

排除标准

  • Having chronic kidney or hepatic disease except NAFLD
  • Havig hypo or hyperthyroidism
  • Having autoimmune and infectious disease
  • weight reduction diet therapy within 6 month from the intervention
  • Having more than 3kg weight change in recent 2 months
  • Having recent surgery
  • Taking anticoagulant drugs

研究组 & 干预措施

Spirulina

Experimental

daily intake of spirulina tablets weight reduction diet therapy

干预措施: diet therapy (Other)

placebo

Placebo Comparator

daily intake of placebo tablets weight reduction diet therapy

干预措施: diet therapy (Other)

Spirulina

Experimental

daily intake of spirulina tablets weight reduction diet therapy

干预措施: Spirulina (Dietary Supplement)

结局指标

主要结局

waist/hip ratio

时间窗: week 12

calculation

body fat free mass

时间窗: week 12

bioempedance

body fat mass

时间窗: week 12

bioempedance

apetite

时间窗: week 12

questionaire

body weight

时间窗: week 12

body weight with minimum of clothes and without shoes through a calibrated scale and with the precision of 100gr

waist circumference

时间窗: week 12

measuring with an inflexible tapeline with the precision of 0.1cm

BMI

时间窗: week 12

calculation

hip circumference

时间窗: week 12

measuring with an inflexible tapeline with the precision of 0.1cm

次要结局

  • serum LDL-C(week 12)
  • serum insulin(week 12)
  • serum LDL-C/HDL-C(week 12)
  • serum fasting glucose(week 12)
  • serum hs-CRP(week 12)
  • serum triaylglycerol(week 12)
  • serum total cholesterol(week 12)
  • e serum HDL-C(week 12)
  • serum SGOT(week12)
  • serum SGPT(week 12)
  • HOMA-IR(week 12)
  • serum adiponectin(week 12)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Atoosa Saidpour

Assistant Professor of Nutrition Science

Shahid Beheshti University of Medical Sciences

研究点 (2)

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