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

February 26, 2026 updated by: Adriyan Pramono, Universitas Diponegoro

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • Central Java
      • Semarang, Central Java, Indonesia, 50275
        • Central Laboratory, UNDIP Academic Hospital (Rumah Sakit Nasional Diponegoro)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.
Other Names:
  • Placebo capsules
Placebo Comparator: 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.
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.
Other Names:
  • Placebo capsules

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Cholesterol
Time Frame: 30 days
Total Cholesterol in mg/dL
30 days
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)
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
30 days
Body Fat Percentage
Time Frame: 30 days
Body fat percentage in percent
30 days
Serum Superoxide Dismutase (SOD) Levels
Time Frame: 30 days
SOD levels in U/mL
30 days
Serum Malondialdehyde (MDA) Levels
Time Frame: 30 days
MDA levels in mmol/L
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitas Diponegoro

Investigators

  • Principal Investigator: Adriyan Pramono, PhD, Department of Nutrition Science, Faculty of Medicine, Diponegoro University, Semarang, Indonesia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 17, 2023

Primary Completion (Actual)

November 16, 2023

Study Completion (Actual)

November 17, 2023

Study Registration Dates

First Submitted

September 19, 2023

First Submitted That Met QC Criteria

October 6, 2023

First Posted (Actual)

October 10, 2023

Study Record Updates

Last Update Posted (Actual)

March 2, 2026

Last Update Submitted That Met QC Criteria

February 26, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CT-390

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Based on the consent from the respondent that already written in inform consent, we cannot legally give the information to anyone else

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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