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Completed

NCT Number: NCT06076161

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

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

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Key information

Age range

25 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Central Laboratory, UNDIP Academic Hospital (Rumah Sakit Nasional Diponegoro)

Semarang, Central Java, 50275, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Spirulina supplementation and calorie restriction in obese men

Dietary Supplement

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.

Other names: Placebo capsules

Primary outcomes

  1. Total Cholesterol

    Time frame: 30 days

    Total Cholesterol in mg/dL

  2. Insulin Resistance - HOMA-IR

    Time frame: 30 days

    Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) will be measured using fasting blood sugar and blood glucose (both in mg/dL)

Secondary outcomes

  1. Body Mass Index (BMI)

    Time frame: 30 days

    Weight in kilograms and height in centimeters. Weight and height will be combined to report BMI in kg/m^2

  2. Serum Superoxide Dismutase (SOD) Levels

    Time frame: 30 days

    SOD levels in U/mL

  3. Serum Malondialdehyde (MDA) Levels

    Time frame: 30 days

    MDA levels in mmol/L

  4. Body Fat Percentage

    Time frame: 30 days

    Body fat percentage in percent

Sponsors and collaborators

Lead sponsor

Universitas Diponegoro

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Oct 10, 2023
Registry last updated
Mar 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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