Clinical Trials Directory

Trials / Completed

CompletedNCT02993627

Effects of Spirulina Supplementation on Overweight or Obese Adults

Effects of Spirulina Supplementation on Anthropometric Measurements, Lipid Profile, Appetite, Liver Enzymes, Inflammatory and Glycemic Markers on Overweight or Obese Adults

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
52 (actual)
Sponsor
Shahid Beheshti University of Medical Sciences · Academic / Other
Sex
All
Age
20 Years – 60 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTSpirulina2 g(4\* 500 mg tablets) daily intake of Spirulina Platensis
OTHERdiet therapylow calorie diet (-500 or -300 kcal) composed of 55% carbohydrate, 15% protein and 30% fat

Timeline

Start date
2016-12-01
Primary completion
2017-07-01
Completion
2017-12-01
First posted
2016-12-15
Last updated
2019-04-11

Locations

1 site across 1 country: Iran

Source: ClinicalTrials.gov record NCT02993627. Inclusion in this directory is not an endorsement.