HIV/AIDS, Insulin Resistance
Conditions
Keywords
Spirulina platensis, Insulin resistance, HIV/AIDS, HAART, Soya beans
Brief 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
Detailed 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.
Interventions
DIETARY_SUPPLEMENTSpirulina platensis
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
DIETARY_SUPPLEMENTSoya bean
Each subject received 19g of supplement on average daily. Subjects were seen every two weeks to evaluate compliance and obtain a new stock.
Sponsors
University of Yaounde
Antenna Technologies
Yaounde Central Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | 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) |
Countries
Cameroon
Outcome results
None listed