Trial | NCT01141777  Report issue

Official Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    33
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
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 Started
Oct 31
2008
Primary Completion
Feb 28
2009
Study Completion
Feb 28
2009
Last Update
Jan 04
2011
Estimate

Dietary Supplement Spirulina 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

  • Other names: Treatment group

Dietary Supplement Soya bean

Each subject received 19g of supplement on average daily. Subjects were seen every two weeks to evaluate compliance and obtain a new stock.

  • Other names: Control group

Spirulina platensis Active Comparator

Soya bean Placebo Comparator

Criteria 

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
No Results Posted