The Effects of Spirulina Platensis on Insulin Resistance in HIV-infected Patients

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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The Effects of Spirulina Platensis on Insulin Resistance in HIV-infected Patients

Conditions
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Insulin Resistance, HIV/AIDS

Intervention / Treatment
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* Dietary Supplement: Spirulina platensis
* Dietary Supplement: Soya bean


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Confirmed HIV infection Accepted to participate in the study Exclusion Criteria: Acute intercurrent infection Treatment that modifies glucose or lipid profile Pregnancy Known diabetic patient Chronic renal failure with calculated creatinine clearance < 60ml/min

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Spirulina platensis<br> | Dietary Supplement: Spirulina platensis<br>* Subjects received 19g daily of supplement averagely.This was supplied as powder daily, in packs that lasted for 2weeks each. Each subject was therefore seen every two week to obtain new stock of supplements and evaluate compliance<br>* Other names: Treatment group;|
| Placebo Comparator: Soya bean<br> | Dietary Supplement: Soya bean<br>* Each subject received 19g of supplement on average daily. Subjects were seen every two weeks to evaluate compliance and obtain a new stock.<br>* Other names: Control group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage difference in change in insulin sensitivity between the two groups at the end of eight weeks of intervention |  | t=0 (baseline), t= week 12 (end of trial) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of subjects who improved insulin sensitivity by the end of the study, compared between the two groups |  | t=0 (baseline), t= week 12 (end of trial) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Spirulina platensis, Insulin resistance, HIV/AIDS, HAART, Soya beans