Effect of Spirulina Platensis Supplementation and Calorie Restriction on Anthropometric, Body Composition, Lipid Profiles, Insulin Resistance, Stress Oxidative Biomarkers In Obese Men: A Randomized Controlled Trial Protocol Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Total Cholesterol
研究概览
简要总结
The goal of this clinical trial is to evaluate the effects of spirulina platensis supplementation and calorie restriction on anthropometric parameters, body composition, lipid profile, insulin resistance, serum superoxide dismutase (SOD) levels, and serum malondialdehyde (MDA) levels in men with obesity. The main question it aims to answer are:
What is the effect of spirulina platensis supplementation and calorie restriction on anthropometric parameters, body composition, lipid profile, insulin resistance, serum Superoxide Dismutase levels, and serum Malondialdehyde levels in obese individuals?
Participants will be respondents were given spirulina supplements for 30 days with a dose of 2x2 capsules 450mg
Researchers will compare intervention group with placebo group that weren't given spirulina supplementation to see if there is any effects on anthropometric parameters, body composition, lipid profile, insulin resistance, serum Superoxide Dismutase levels, and serum Malondialdehyde levels
详细描述
Spirulina supplement intervention on subjects with male gender aged 25-55 years, which will be intervened for 4 weeks / 30 days, before the intervention will be taken anthropometric parameters, body composition, lipid profile, insulin resistance, serum Superoxide Dismutase levels, and serum Malondialdehyde levels.
After that, spirulina supplement intervention will be given at a dose of 2x2 / day, and follow-up will be carried out every week, after 30 hours of intervention,spirulina supplement distribution is carried out by research assistants every 2 days.
Will be taken again to conduct anthropometric parameters, body composition, lipid profile, insulin resistance, serum Superoxide Dismutase levels, and serum Malondialdehyde levels.
The aim is to find out if there is an effect of spirulina supplementation on anthropometric parameters, body composition, lipid profile, insulin resistance, serum Superoxide Dismutase levels, and serum Malondialdehyde levels.
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)
盲法说明
This study will use a randomized controlled trial triple blind study design with a pre-post design.
入排标准
- 年龄范围
- 25 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male Age 25 - 55 years
- •BMI ≥ 30 kg/m2
- •Waist Circumference > 90 cm
- •Low physical activity (Sedentary life style)
- •If taking weight loss supplements are willing to stop the dietary supplements, food or drinks.
- •Not undergoing a diet program.
排除标准
- •History of kidney disease, atherosclerosis, cancer, and acute infections.
- •Post-surgery in the last 3 months.
- •Deficit in daily calorie requirement.
- •Smoking habit and alcohol dependence.
- •Use of hormonal drugs, antidepressant drugs, antibiotics, antidiuretic, glucocorticoids and use of vitamin or mineral supplements in the last three months.
- •Refusal to sign the informed consent and in the study if not completing all stages will be excluded.
研究组 & 干预措施
Spirulina supplementation and calorie restriction in obese men
Respondents will be divided into 2 groups, namely the intervention group and the control group. The intervention group will be given spirulina platensis supplements at a dose of 2x2 /hr with a dose per capsule of 450 mg for 4 weeks with education about calorie restriction.
干预措施: Spirulina supplementation and calorie restriction in obese men (Dietary Supplement)
Placebo capsules and calorie restriction in obese men
The control group will be given placebo 2x2/day for 4 weeks with education on calorie restriction.
干预措施: Spirulina supplementation and calorie restriction in obese men (Dietary Supplement)
结局指标
主要结局
Total Cholesterol
时间窗: 30 days
Total Cholesterol in mg/dL
Insulin Resistance - HOMA-IR
时间窗: 30 days
Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) will be measured using fasting blood sugar and blood glucose (both in mg/dL)
次要结局
- Body Mass Index (BMI)(30 days)
- Body Fat Percentage(30 days)
- Serum Superoxide Dismutase (SOD) Levels(30 days)
- Serum Malondialdehyde (MDA) Levels(30 days)
研究者
Adriyan Pramono
Lecturer
Universitas Diponegoro