Clinical Nutrition and Diet Therapy Clinic of Shahid Beheshti University of Medical Sciences
Tehran, 1981619573, Iran
NCT Number: NCT02993627
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.
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Notify Me20 year–60 year
All sexes
Interventional
Not applicable
Tehran, 1981619573, Iran
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
2 g(4* 500 mg tablets) daily intake of Spirulina Platensis
Other names: Spiruvit
low calorie diet (-500 or -300 kcal) composed of 55% carbohydrate, 15% protein and 30% fat
Other names: weight reduction diet
Time frame: week 12
body weight with minimum of clothes and without shoes through a calibrated scale and with the precision of 100gr
Time frame: week 12
calculation
Time frame: week 12
measuring with an inflexible tapeline with the precision of 0.1cm
Time frame: week 12
measuring with an inflexible tapeline with the precision of 0.1cm
Time frame: week 12
calculation
Time frame: week 12
bioempedance
Time frame: week 12
bioempedance
Time frame: week 12
questionaire
Time frame: week 12
enzymatic method
Time frame: week 12
enzymatic method
Time frame: week 12
enzymatic method
Time frame: week 12
calculation
Time frame: week 12
calculation
Time frame: week 12
enzymatic method
Time frame: week 12
enzymatic method
Time frame: week 12
calculation
Time frame: week 12
eliza
Time frame: week 12
eliza
Time frame: week12
enzymatic method
Time frame: week 12
enzymatic method
Shahid Beheshti University of Medical Sciences
Other
Effects of Spirulina Supplementation on Anthropometric Measurements, Lipid Profile, Appetite, Liver Enzymes, Inflammatory and Glycemic Markers on Overweight or Obese Adults
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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