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Effect of Spirulina and Combined Exercise on Cardiometabolic, Cognitive and Physical Health

Spirulina and Combined Exercise for Cardiometabolic, Cognitive and Physical Health: A Randomized, Double-Blind, Placebo-Controlled Trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20231004059615N9
Enrollment
320
Registered
2026-04-04
Start date
2026-02-16
Completion date
Unknown
Last updated
2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Condition 1: Overweight and obesity. Condition 2: Metabolic syndrome. Condition 3: Menopausal and female climacteric states. Condition 4: Age-related cognitive decline. Condition 5: Sarcopenia. Overweight and obesity Metabolic syndrome Menopausal and female climacteric states Age-related cognitive decline

Interventions

Intervention 1: Intervention group: 1. Spirulina supplementation (Now Health Group, Bloomingdale, USA
2 g/day in 2 times, 1 g each time with breakfast and dinner) for 12 weeks
n = 80
. Intervention 2: Intervention group: 2. Combined exercise training (including high-intensity interval training, resistance training, and aerobic training
duration of each session 60-75 min
3 sessions/week) for 12 weeks
. Intervention 3: Intervention group: 3. Spirulina supplementation (Now Health Group, Bloomingdale, USA
2 g/day in 2 times, 1 g each time with breakfast and dinner)+ combined exercise training (including high-intensity interval training, resistance training, and aerobic training
. Intervention 4: Control group: 4. Placebo control (Cellulose
2 g/day in 2 times, 1 g each time with breakfast and dinner
no exercise) for 12 weeks
n = 80.

Sponsors

INTERNATIONAL SCIENCE AND TECHNOLOGY UNIVERSITY
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: Body mass index between 18.9 and 39.9 kg/m2 Not engaged in regular exercise activities over the last six months No smoking or alcohol consumption Absence of chronic diseases (cardiovascular disease, liver abnormalities, etc.)

Exclusion criteria

Exclusion criteria: Having any pain or movement limitations that prevent interventions. Current treatment with medication or supplements that significantly affect the main study variables. Having a history of bariatric surgery Following a special diet within the past six months

Design outcomes

Primary

MeasureTime frame
Body composition. Timepoint: Before and after 12 weeks of intervention as well as following a 3-month follow-up. Method of measurement: By Dual-Energy X-ray Absorptiometry (DXA).;Maximal oxygen uptake (VO2max). Timepoint: Before and after 12 weeks of intervention as well as following a 3-month follow-up. Method of measurement: Using the Gas analyzer instrument.;Muscle strength. Timepoint: Before and after 12 weeks of intervention as well as following a 3-month follow-up. Method of measurement: Using an isometric strength dynamometer.;Glucose homeostasis. Timepoint: Before and after 12 weeks of intervention as well as following a 3-month follow-up. Method of measurement: By measuring fasting glucose and insulin, insulin sensitivity, and the homeostasis model of assessment-insulin resistance (HOMA-IR).

Secondary

MeasureTime frame
Muscular endurance. Timepoint: Before and after 12 weeks of intervention as well as following a 3-month follow-up. Method of measurement: By repeated execution with 70% 1RM.;Cognitive function. Timepoint: Before and after 12 weeks of intervention as well as following a 3-month follow-up. Method of measurement: By Mini-mental state examination score (MMSE).;Inflammation. Timepoint: Before and after 12 weeks of intervention as well as following a 3-month follow-up. Method of measurement: Using ELISA method.;Lipid profile. Timepoint: Before and after 12 weeks of intervention as well as following a 3-month follow-up. Method of measurement: Biochemical analysis.;Oxidative stress. Timepoint: Before and after 12 weeks of intervention as well as following a 3-month follow-up. Method of measurement: Using ELISA method.;Plasma levels of fat browning factors. Timepoint: Before and after 12 weeks of intervention as well as following a 3-month follow-up. Method of measurement: Using ELISA method.;Brain-derived neurotrophic factor. Timepoint: Before and after 12 weeks of intervention as well as following a 3-month follow-up. Method of measurement: Using ELISA method.;Blood pressure. Timepoint: Before and after 12 weeks of intervention as well as following a 3-month follow-up. Method of measurement: Digital blood pressure monitor.;Vascular endothelial growth factor (VEGF). Timepoint: Before and after 12 weeks of intervention as well as following a 3-month follow-up. Method of measurement: Using ELISA method.;Fibroblast Growth Factor 21 (FGF21). Timepoint: Before and after 12 weeks of intervention as well as following a 3-month follow-up. Method of measurement: Using ELISA method.;Irisin. Timepoint: Before and after 12 weeks of intervention as well as following a 3-month follow-up. Method of measurement: Using ELISA method.;Adiponectin. Timepoint: Before and after 12 weeks of intervention as well as following a 3-month follow-up. Method of measurement: Using ELISA method.;Physical

Countries

Turkey

Contacts

Public ContactDavar Khodadadi

Islamic Azad University

davar.khodadadi@yahoo.com+98 21 2263 3583

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Jun 11, 2026