NCT06076161

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Oct 2023

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 19, 2023

Completed
21 days until next milestone

First Posted

Study publicly available on registry

October 10, 2023

Completed
7 days until next milestone

Study Start

First participant enrolled

October 17, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 16, 2023

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 17, 2023

Completed
Last Updated

March 2, 2026

Status Verified

February 1, 2026

Enrollment Period

1 month

First QC Date

September 19, 2023

Last Update Submit

February 26, 2026

Conditions

Obesity

Outcome Measures

Primary Outcomes (2)

  • Total Cholesterol

    Total Cholesterol in mg/dL

    30 days

  • 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 Outcomes (4)

  • Body Mass Index (BMI)

    30 days

  • Serum Superoxide Dismutase (SOD) Levels

    30 days

  • Serum Malondialdehyde (MDA) Levels

    30 days

  • Body Fat Percentage

    30 days

Study Arms (2)

Spirulina supplementation and calorie restriction in obese men

EXPERIMENTAL

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

Placebo capsules and calorie restriction in obese men

PLACEBO COMPARATOR

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

Interventions

Spirulina supplementation and calorie restriction in obese menDIETARY_SUPPLEMENT

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.

Also known as: Placebo capsules
Placebo capsules and calorie restriction in obese menSpirulina supplementation and calorie restriction in obese men

Eligibility Criteria

Age25 Years - 55 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsObese men
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Central Laboratory, UNDIP Academic Hospital (Rumah Sakit Nasional Diponegoro)

Semarang, Central Java, 50275, Indonesia

Location

Related Publications (12)

  • 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.

    PMID: 21686173BACKGROUND

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

    PMID: 30814686BACKGROUND

  • 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.

    PMID: 30577684BACKGROUND

  • 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.

    PMID: 19136980BACKGROUND

  • 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.

    PMID: 30253139BACKGROUND

  • 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.

    PMID: 9216458RESULT

  • 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 10;8:e1095. doi: 10.31661/gmj.v8i0.1095. eCollection 2019.

    PMID: 34466462RESULT

  • 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 clinical trials. Phytother Res. 2021 Feb;35(2):577-586. doi: 10.1002/ptr.6834. Epub 2020 Sep 23.

    PMID: 32967062RESULT

  • 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 Pract. 2021 Oct;75(10):e14618. doi: 10.1111/ijcp.14618. Epub 2021 Aug 4.

    PMID: 34235823RESULT

  • 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.2019.102211. Epub 2019 Oct 17.

    PMID: 31780031RESULT

  • 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 Fitness of Overweight or Obese Subjects: A Double-Blind, Randomized, and Crossover Controlled Trial. Mar Drugs. 2018 Oct 1;16(10):364. doi: 10.3390/md16100364.

    PMID: 30275428RESULT

  • 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.

    PMID: 32201580RESULT

Related Links

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Adriyan Pramono, PhD

    Department of Nutrition Science, Faculty of Medicine, Diponegoro University, Semarang, Indonesia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
This study will use a randomized controlled trial triple blind study design with a pre-post design.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

September 19, 2023

First Posted

October 10, 2023

Study Start

October 17, 2023

Primary Completion

November 16, 2023

Study Completion

November 17, 2023

Last Updated

March 2, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

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

Locations

ID(1)