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Completed

NCT Number: NCT01141777

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

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

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Key information

Conditions

Insulin Resistance Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases Glucose Metabolism Disorders HIV Infections HIV/AIDS Hyperinsulinism Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Metabolic Diseases Nutritional and Metabolic Diseases RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Obesity Centre, Yaounde Central Hospital

Yaoundé, Centre Region, Cameroon

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Spirulina platensis

Dietary Supplement

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

Soya bean

Dietary Supplement

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

Primary outcomes

  1. 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

  1. Percentage of subjects who improved insulin sensitivity by the end of the study, compared between the two groups

    Time frame: t=0 (baseline), t= week 12 (end of trial)

Sponsors and collaborators

Lead sponsor

Yaounde Central Hospital

Other Gov

Collaborators

  • Antenna Technologies
  • University of Yaounde

Registry information

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jun 11, 2010
Registry last updated
Jan 4, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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