Effects of Spirulina Supplementation on Overweight or Obese Adults

Shahid Beheshti University of Medical Sciences

Status: Completed

Conditions: Obesity

Treatments: Other: diet therapy; Dietary Supplement: Spirulina

Study type: Interventional

Funder types: Other

Identifiers

NCT02993627

IR.SBMU.nnftri.Rec.1395.63

Details and patient eligibility

About

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.

Full 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.

Enrollment: 52 patients

Sex: All

Ages: 20 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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52 participants in 2 patient groups, including a placebo group

Spirulina

Experimental group

Description:

daily intake of spirulina tablets weight reduction diet therapy

Treatment:

Dietary Supplement: Spirulina

Other: diet therapy

placebo

Placebo Comparator group

Description:

daily intake of placebo tablets weight reduction diet therapy

Treatment:

Other: diet therapy