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

This study has been completed.
Sponsor:
Collaborators:
University of Yaounde
Antenna Technologies
Information provided by:
Yaounde Central Hospital
ClinicalTrials.gov Identifier:
NCT01141777
First received: June 10, 2010
Last updated: January 3, 2011
Last verified: September 2010
History of Changes

June 10, 2010
January 3, 2011
October 2008
February 2009   (final data collection date for primary outcome measure)
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) ] [ Designated as safety issue: No ]
Percentage difference in insulin sensitivity within and between the two trial groups at the end of the study [ Time Frame: t=0 (baseline), t= week 12 (end of trial) ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01141777 on ClinicalTrials.gov Archive Site
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) ] [ Designated as safety issue: No ]
Difference in body composition parameters within and between each group at the end of the study [ Time Frame: t=0 (baseline), t= week 12 (end of trial) ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
The Effects of Spirulina Platensis on Insulin Resistance in HIV-infected Patients
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

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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
  • Insulin Resistance
  • HIV/AIDS
  • 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 Name: 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 Name: Control group
  • Active Comparator: Spirulina platensis
    Intervention: Dietary Supplement: Spirulina platensis
  • Placebo Comparator: Soya bean
    Intervention: Dietary Supplement: Soya bean
Marcel AK, Ekali LG, Eugene S, Arnold OE, Sandrine ED, von der Weid D, Gbaguidi E, Ngogang J, Mbanya JC. The effect of Spirulina platensis versus soybean on insulin resistance in HIV-infected patients: a randomized pilot study. Nutrients. 2011 Jul;3(7):712-24. Epub 2011 Jul 18.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
33
February 2009
February 2009   (final data collection date for primary outcome measure)

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
Both
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Cameroon
 
NCT01141777
MAK-GLE_Spirulina
No
Dr Sobngwi Eugene, Consultant Endocrinologist and Senior Lecturer, University of Yaounde 1, Cameroon and Newcastle University, UK
Yaounde Central Hospital
  • University of Yaounde
  • Antenna Technologies
Study Director: Pr Jean Claude Mbanya, MD, PhD International diabetes federation/ Director, National Obesity Centre, Yaounde Central Hospital, Cameroon
Principal Investigator: Dr Sobngwi Eugene, MD, PhD Consultant Endocrinologist, National Obesity Centre/ Senior Lecturer, University of Yaounde 1, Cameroon and Newcastle University, UK
Study Chair: Dr Marcel Azabji Kenfack, MD Dep. of Physiologie, Faculty of Medicine and Biomedical Sciences University Yaoundé I, Cameroon
Principal Investigator: Dr Gabriel Loni Ekali, MD National Obesity Centre, Yaounde Central Hospital, Cameroon
Yaounde Central Hospital
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP