Clinical trial NCT06076161: Spirulina Platensis Supplementation and Calorie Restriction in Obese Men : A Randomized Controlled Trial Protocol Study
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: Universitas Diponegoro
Sponsor class: OTHER
First posted: 2023-10-10
Enrollment: 32
Sex: MALE
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Total Cholesterol
timeFrame: 30 days
measure: Insulin Resistance - HOMA-IR
timeFrame: 30 days
Secondary outcomes:
measure: Body Mass Index (BMI)
timeFrame: 30 days
measure: Serum Superoxide Dismutase (SOD) Levels
timeFrame: 30 days
measure: Serum Malondialdehyde (MDA) Levels
timeFrame: 30 days
measure: Body Fat Percentage
timeFrame: 30 days
Other outcomes:
Locations:
city: Semarang
country: Indonesia
facility: Central Laboratory, UNDIP Academic Hospital (Rumah Sakit Nasional Diponegoro)
state: Central Java
Study officials:
affiliation: Department of Nutrition Science, Faculty of Medicine, Diponegoro University, Semarang, Indonesia
name: Adriyan Pramono, PhD
role: PRINCIPAL_INVESTIGATOR
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