The Effects of Spirulina Platensis on Insulin Resistance in HIV-infected Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 33
- Locations
- 1
- Primary Endpoint
- Percentage difference in change in insulin sensitivity between the two groups at the end of eight weeks of intervention
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 21 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
Percentage difference in change in insulin sensitivity between the two groups at the end of eight weeks of intervention
Time Frame: t=0 (baseline), t= week 12 (end of trial)
Secondary Outcomes
- 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))