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Clinical Trial Summary

Spirulina, a widely used food supplement, improves the lipid profile and glycemic control in people living with diabetes, suggesting that it could have some effects on insulin sensitivity. Since HIV-infected patients develop metabolic abnormalities due to the virus and/or to antiretroviral (ARV) drugs, the investigators therefore proposed to evaluate the effect that spirulina can have on HIV/HAART-associated insulin resistance


Clinical Trial Description

Even though antiretroviral therapy (ART) has dramatically improved the health of people living with HIV/AIDS, the prospect of maintaining patients long term on ART can be severely restricted by the development of serious long term effects in their metabolism. These abnormalities include dyslipidemia, lipodystrophy and disorders of glucose metabolism with insulin resistance believed to be the underlying pathophysiological mechanism.

Spirulina, has recently drawn attention on its cholesterol and blood pressure lowering effects, including improvement of glycaemic control in diabetics subjects, suggesting it can have some effects on insulin sensitivity.

The aim of this three month, experimental, prospective, randomised trial was to evaluate the effect of Spirulina on HIV/HAART-associated insulin resistance on 33 subjects. Primary outcome was change in insulin sensitivity during the trial, over two time periods; t=0 and t=12 weeks. The second objective was to compare between the two groups, the percentage of subjects who improved insulin sensitivity by the end of the study.

Recruitment started in October 2008 and the trial ended in February 2009. ;


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care


Related Conditions & MeSH terms


NCT number NCT01141777
Study type Interventional
Source Yaounde Central Hospital
Contact
Status Completed
Phase N/A
Start date October 2008
Completion date February 2009

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