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

Obesity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06076161
• Other study ID #: CT-390
• Status: Completed
• Phase: N/A
• Start date: October 17, 2023
• Est. completion date: November 17, 2023

Study information

• Verified date: February 2024
• Source: Universitas Diponegoro
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: November 17, 2023
• Est. primary completion date: November 16, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 25 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity

Intervention

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.

Locations

Country	Name	City	State
Indonesia	Central Laboratory, UNDIP Academic Hospital (Rumah Sakit Nasional Diponegoro)	Semarang	Central Java

Sponsors (1)

Lead Sponsor	Collaborator
Universitas Diponegoro

Country where clinical trial is conducted

Indonesia, 

References & Publications (12)

Bluher M. Obesity: global epidemiology and pathogenesis. Nat Rev Endocrinol. 2019 May;15(5):288-298. doi: 10.1038/s41574-019-0176-8. — View Citation

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. — View Citation

DiNicolantonio JJ, Bhat AG, OKeefe J. Effects of spirulina on weight loss and blood lipids: a review. Open Heart. 2020 Mar 8;7(1):e001003. doi: 10.1136/openhrt-2018-001003. eCollection 2020. — View Citation

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. — View Citation

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. — View Citation

Hernandez-Lepe MA, Lopez-Diaz JA, Juarez-Oropeza MA, Hernandez-Torres RP, Wall-Medrano A, Ramos-Jimenez A. Effect of Arthrospira (Spirulina) maxima Supplementation and a Systematic Physical Exercise Program on the Body Composition and Cardiorespiratory Fi — View Citation

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. — View Citation

Moradi S, Ziaei R, Foshati S, Mohammadi H, Nachvak SM, Rouhani MH. Effects of Spirulina supplementation on obesity: A systematic review and meta-analysis of randomized clinical trials. Complement Ther Med. 2019 Dec;47:102211. doi: 10.1016/j.ctim.2019.1022 — View Citation

Naeini F, Zarezadeh M, Mohiti S, Tutunchi H, Ebrahimi Mamaghani M, Ostadrahimi A. Spirulina supplementation as an adjuvant therapy in enhancement of antioxidant capacity: A systematic review and meta-analysis of controlled clinical trials. Int J Clin Prac — View Citation

Nielsen F, Mikkelsen BB, Nielsen JB, Andersen HR, Grandjean P. Plasma malondialdehyde as biomarker for oxidative stress: reference interval and effects of life-style factors. Clin Chem. 1997 Jul;43(7):1209-14. — View Citation

Rezaei N, Eftekhari MH, Tanideh N, Mokhtari M, Bagheri Z. Comparison of Antioxidant and Anti-Inflammatory Effects of Honey and Spirulina platensis with Sulfasalazine and Mesalazine on Acetic Acid-Induced Ulcerative Colitis in Rats. Galen Med J. 2019 Jun 1 — View Citation

Zarezadeh M, Faghfouri AH, Radkhah N, Foroumandi E, Khorshidi M, Rasouli A, Zarei M, Mohammadzadeh Honarvar N, Hazhir Karzar N, Ebrahimi Mamaghani M. Spirulina supplementation and anthropometric indices: A systematic review and meta-analysis of controlled — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Cholesterol	Total Cholesterol in mg/dL	30 days
Primary	Insulin Resistance - HOMA-IR	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	Body Mass Index (BMI)	Weight in kilograms and height in centimeters. Weight and height will be combined to report BMI in kg/m^2	30 days
Secondary	Serum Superoxide Dismutase (SOD) Levels	SOD levels in U/mL	30 days
Secondary	Serum Malondialdehyde (MDA) Levels	MDA levels in mmol/L	30 days
Secondary	Body Fat Percentage	Body fat percentage in percent	30 days

External Links

•   Anti-inflammatory and antithrombotic properties of polar lipid extracts, rich in unsaturated fatty acids, from the Irish marine cyanobacterium Spirulina subsalsa
•   Comparison of Antioxidant and Anti-Inflammatory Effects of Honey and Spirulina platensis with Sulfasalazine and Mesalazine on Acetic Acid-Induced Ulcerative Colitis in Rats
•   Impact of spirulina supplementation on obesity-related metabolic disorders: A systematic review and meta-analysis of randomized controlled trials
•   Inflammation and Oxidative Stress in an Obese State and the Protective Effects of Gallic Acid
•   Inflammation, oxidative stress, and obesity
•   Obesity: global epidemiology and pathogenesis
•   The epidemiology of obesity