Effects of Spirulina Supplementation on Overweight or Obese Adults

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Dietary Supplement: Spirulina; Other: diet therapy

• Registration Number: NCT02993627
• Lead Sponsor: Shahid Beheshti University of Medical Sciences

Brief Summary

In this double-blind Randomized Controlled Clinical Trial investigators are going to study the effects of Spirulina supplementation on anthropometric measurements, lipid profile, appetite, liver enzymes, inflammatory and glycemic markers in a sample of overweight or obese adults.

Detailed Description

A sample of 40 obese and overweight subjects will be recruited from Nutrition And Diet Therapy Clinic Of Shahid Beheshti Medical University.

This study is a double-blind Randomized Controlled Clinical Trial, that subjects will be randomly allocated to spirulina or placebo group according to the Random permuted blocks within strata method based on BMI. Subjects will consume 2 g spirulina daily (4 tablets of 500mg), whereas the control group are going to receive identical placebo tablets. Subjects are asked to maintain their usual physical activity level during the intervention period and also avoid taking any other supplements or medications without consulting the investigators. Intervention period is designed to be 12 weeks that has been determined sufficient to record changes of study parameters. At the beginning of the study and after 12 weeks of intervention, morning blood samples will be collected after 12 h of fasting. Anthropometric parameters will be also measured at the beginning, week 6 and after 12 weeks of intervention. Subjects will be followed through social network to ensure their compliance with the study. Furthermore, subjects in both spirulina and placebo groups received low calorie diet (-500 or -300 kcal) composed of 55% carbohydrate, 15% protein and 30% fat during the study period.

Study Timeline

• Study First Submitted: 2016-11-27
• Study Start: 2016-12
• Study First Submitted QC: 2016-12-13
• Study First Posted: 2016-12-15
• Primary Completion: 2017-07
• Study Completion: 2017-12
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-10
• Last Update Posted: 2019-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

• BMI>25 kg/m2
• No history of medications for obesity, diabetes, dyslipidemia, inflammatory disease within 3 months before the study
• No history of vitamin or antioxidant supplementation within 3 months before the study
• Giving written informed consent for participation

Exclusion Criteria

• Having chronic kidney or hepatic disease except NAFLD
• Havig hypo or hyperthyroidism
• Having autoimmune and infectious disease
• weight reduction diet therapy within 6 month from the intervention
• Having more than 3kg weight change in recent 2 months
• Having recent surgery
• Taking anticoagulant drugs

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Spirulina	Spirulina	daily intake of spirulina tablets weight reduction diet therapy
Spirulina	diet therapy	daily intake of spirulina tablets weight reduction diet therapy
placebo	diet therapy	daily intake of placebo tablets weight reduction diet therapy

Primary Outcome Measures

Name	Time	Method
waist/hip ratio	week 12	calculation
body fat free mass	week 12	bioempedance
BMI	week 12	calculation
body fat mass	week 12	bioempedance
apetite	week 12	questionaire
body weight	week 12	body weight with minimum of clothes and without shoes through a calibrated scale and with the precision of 100gr
waist circumference	week 12	measuring with an inflexible tapeline with the precision of 0.1cm
hip circumference	week 12	measuring with an inflexible tapeline with the precision of 0.1cm

Secondary Outcome Measures

Name	Time	Method
serum LDL-C	week 12	calculation
serum insulin	week 12	enzymatic method
serum hs-CRP	week 12	eliza
HOMA-IR	week 12	calculation
serum LDL-C/HDL-C	week 12	calculation
serum fasting glucose	week 12	enzymatic method
serum triaylglycerol	week 12	enzymatic method
serum total cholesterol	week 12	enzymatic method
e serum HDL-C	week 12	enzymatic method
serum SGOT	week12	enzymatic method
serum SGPT	week 12	enzymatic method
serum adiponectin	week 12	eliza

Trial Locations

Locations (1)

Clinical Nutrition and Diet Therapy Clinic of Shahid Beheshti University of Medical Sciences; 🇮🇷 Tehran, Iran, Islamic Republic of