Spirulina Platensis Supplementation and Calorie Restriction in Obese Men : A Randomized Controlled Trial Protocol Study
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| 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:
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| 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:
|
Outcome Measures
Primary Outcome Measures
- Body Mass Index (BMI) [30 days]
Weight in kilograms and height in centimeters. Weight and height will be combined to report BMI in kg/m^2
- Body Fat Percentage [30 days]
Body fat percentage in percent
- Total Cholesterol [30 days]
Total Cholesterol in mg/dL
- Insulin Resistance - HOMA-IR [30 days]
Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) will be measured using fasting blood sugar and blood glucose (both in mg/dL)
- Serum Superoxide Dismutase (SOD) Levels [30 days]
SOD levels in U/mL
- Serum Malondialdehyde (MDA) Levels [30 days]
MDA levels in mmol/L
Eligibility Criteria
Criteria
Inclusion Criteria:
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Male Age 25 - 55 years
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BMI ≥ 30 kg/m2
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Waist Circumference > 90 cm
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Low physical activity (Sedentary life style)
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If taking weight loss supplements are willing to stop the dietary supplements, food or drinks.
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Not undergoing a diet program.
Exclusion Criteria:
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History of kidney disease, atherosclerosis, cancer, and acute infections.
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Post-surgery in the last 3 months.
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Deficit in daily calorie requirement.
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Smoking habit and alcohol dependence.
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Use of hormonal drugs, antidepressant drugs, antibiotics, antidiuretic, glucocorticoids and use of vitamin or mineral supplements in the last three months.
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Refusal to sign the informed consent and in the study if not completing all stages will be excluded.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Universitas Diponegoro
Investigators
- Principal Investigator: Adriyan Pramono, PhD, Department of Nutrition Science, Faculty of Medicine, Diponegoro University, Semarang, Indonesia
Study Documents (Full-Text)
None provided.More Information
Additional Information:
- Inflammation, oxidative stress, and obesity
- Obesity: global epidemiology and pathogenesis
- Inflammation and Oxidative Stress in an Obese State and the Protective Effects of Gallic Acid
- The epidemiology of obesity
- Comparison of Antioxidant and Anti-Inflammatory Effects of Honey and Spirulina platensis with Sulfasalazine and Mesalazine on Acetic Acid-Induced Ulcerative Colitis in Rats
- Anti-inflammatory and antithrombotic properties of polar lipid extracts, rich in unsaturated fatty acids, from the Irish marine cyanobacterium Spirulina subsalsa
- Impact of spirulina supplementation on obesity-related metabolic disorders: A systematic review and meta-analysis of randomized controlled trials
Publications
- Bluher M. Obesity: global epidemiology and pathogenesis. Nat Rev Endocrinol. 2019 May;15(5):288-298. doi: 10.1038/s41574-019-0176-8.
- Chooi YC, Ding C, Magkos F. The epidemiology of obesity. Metabolism. 2019 Mar;92:6-10. doi: 10.1016/j.metabol.2018.09.005. Epub 2018 Sep 22.
- Dludla PV, Nkambule BB, Jack B, Mkandla Z, Mutize T, Silvestri S, Orlando P, Tiano L, Louw J, Mazibuko-Mbeje SE. Inflammation and Oxidative Stress in an Obese State and the Protective Effects of Gallic Acid. Nutrients. 2018 Dec 21;11(1):23. doi: 10.3390/nu11010023.
- Fernandez-Sanchez A, Madrigal-Santillan E, Bautista M, Esquivel-Soto J, Morales-Gonzalez A, Esquivel-Chirino C, Durante-Montiel I, Sanchez-Rivera G, Valadez-Vega C, Morales-Gonzalez JA. Inflammation, oxidative stress, and obesity. Int J Mol Sci. 2011;12(5):3117-32. doi: 10.3390/ijms12053117. Epub 2011 May 13.
- James WP. WHO recognition of the global obesity epidemic. Int J Obes (Lond). 2008 Dec;32 Suppl 7:S120-6. doi: 10.1038/ijo.2008.247.
- CT-390