Spirulina Platensis Supplementation and Calorie Restriction in Obese Men : A Randomized Controlled Trial Protocol Study

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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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

Conditions
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Obesity

Intervention / Treatment
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* Dietary Supplement: Spirulina supplementation and calorie restriction in obese men


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The number of respondents in this study amounted to 32 people. 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. The control group will be given placebo 2x2/day for 4 weeks with education on calorie restriction.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Spirulina supplementation and calorie restriction in obese men<br>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. | Dietary Supplement: Spirulina supplementation and calorie restriction in obese men<br>* 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. The control group will be given placebo 2x2/day for 4 weeks with education on calorie restriction.<br>* Other names: Placebo capsules;|
| Placebo Comparator: Placebo capsules and calorie restriction in obese men<br>The control group will be given placebo 2x2/day for 4 weeks with education on calorie restriction. | Dietary Supplement: Spirulina supplementation and calorie restriction in obese men<br>* 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. The control group will be given placebo 2x2/day for 4 weeks with education on calorie restriction.<br>* Other names: Placebo capsules;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Mass Index (BMI) | Weight in kilograms and height in centimeters. Weight and height will be combined to report BMI in kg/m^2 | 30 days | 
| Body Fat Percentage | Body fat percentage in percent | 30 days | 
| Total Cholesterol | Total Cholesterol in mg/dL | 30 days | 
| Insulin Resistance - HOMA-IR | Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) will be measured using fasting blood sugar and blood glucose (both in mg/dL) | 30 days | 
| Serum Superoxide Dismutase (SOD) Levels | SOD levels in U/mL | 30 days | 
| Serum Malondialdehyde (MDA) Levels | MDA levels in mmol/L | 30 days |