Effects of Spirulina Supplementation on Anthropometric Measurements, Lipid Profile, Appetite, Liver Enzymes, Inflammatory and Glycemic Markers on Overweight or Obese Adults
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
- 是
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
daily intake of spirulina tablets weight reduction diet therapy
干预措施: diet therapy (Other)
placebo
daily intake of placebo tablets weight reduction diet therapy
干预措施: diet therapy (Other)
Spirulina
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
Atoosa Saidpour
Assistant Professor of Nutrition Science
Shahid Beheshti University of Medical Sciences
