Obesity
Conditions
Keywords
obesity, BMI, body weight
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.
Interventions
DIETARY_SUPPLEMENTSpirulina
2 g(4\* 500 mg tablets) daily intake of Spirulina Platensis
OTHERdiet therapy
low calorie diet (-500 or -300 kcal) composed of 55% carbohydrate, 15% protein and 30% fat
Sponsors
Shahid Beheshti University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| body weight | week 12 | body weight with minimum of clothes and without shoes through a calibrated scale and with the precision of 100gr |
| BMI | week 12 | calculation |
| 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 |
| waist/hip ratio | week 12 | calculation |
| body fat mass | week 12 | bioempedance |
| body fat free mass | week 12 | bioempedance |
| apetite | week 12 | questionaire |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| serum hs-CRP | week 12 | eliza |
| serum adiponectin | week 12 | eliza |
| serum triaylglycerol | week 12 | enzymatic method |
| serum SGPT | week 12 | enzymatic method |
| serum SGOT | week12 | enzymatic method |
| serum total cholesterol | week 12 | enzymatic method |
| e serum HDL-C | week 12 | enzymatic method |
| serum LDL-C | week 12 | calculation |
| serum LDL-C/HDL-C | week 12 | calculation |
| serum fasting glucose | week 12 | enzymatic method |
| serum insulin | week 12 | enzymatic method |
| HOMA-IR | week 12 | calculation |
Countries
Iran
Outcome results
None listed