NCT06076161

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Universitas Diponegoro · Academic / Other
• Sex: Male
• Age: 25 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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

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.

Conditions

• Obesity

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Spirulina supplementation and calorie restriction in obese men	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.

Timeline

• Start date: 2023-10-17
• Primary completion: 2023-11-16
• Completion: 2023-11-17
• First posted: 2023-10-10
• Last updated: 2026-03-02

Locations

1 site across 1 country: Indonesia