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

Universitas Diponegoro

Status: Completed

Conditions: Obesity

Treatments: Dietary Supplement: Spirulina supplementation and calorie restriction in obese men

Study type: Interventional

Funder types: Other

Identifiers

NCT06076161

CT-390

Details and patient eligibility

About

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

Full 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.

Enrollment: 32 patients

Sex: Male

Ages: 25 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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32 participants in 2 patient groups, including a placebo group

Spirulina supplementation and calorie restriction in obese men

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Spirulina supplementation and calorie restriction in obese men

Placebo capsules and calorie restriction in obese men

Placebo Comparator group

Description:

The control group will be given placebo 2x2/day for 4 weeks with education on calorie restriction.

Treatment:

Dietary Supplement: Spirulina supplementation and calorie restriction in obese men