Clinical trial NCT01141777: The Effects of Spirulina Platensis on Insulin Resistance in HIV-infected Patients
Official title: The Effects of Spirulina Platensis on Insulin Resistance in HIV-infected Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insulin Resistance
HIV/AIDS
Keywords: Spirulina platensis
Insulin resistance
HIV/AIDS
HAART
Soya beans
Lead sponsor: Yaounde Central Hospital
Sponsor class: OTHER_GOV
Collaborators: name: University of Yaounde
name: Antenna Technologies
First posted: 2010-06-11
Enrollment: 33
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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

Primary outcomes:
measure: Percentage difference in change in insulin sensitivity between the two groups at the end of eight weeks of intervention
timeFrame: t=0 (baseline), t= week 12 (end of trial)
Secondary outcomes:
measure: Percentage of subjects who improved insulin sensitivity by the end of the study, compared between the two groups
timeFrame: t=0 (baseline), t= week 12 (end of trial)
Other outcomes:
Locations:
city: Yaounde
country: Cameroon
facility: National Obesity Centre, Yaounde Central Hospital
state: Centre
Study officials:
affiliation: International diabetes federation/ Director, National Obesity Centre, Yaounde Central Hospital, Cameroon
name: Pr Jean Claude Mbanya, MD, PhD
role: STUDY_DIRECTOR
affiliation: Consultant Endocrinologist, National Obesity Centre/ Senior Lecturer, University of Yaounde 1, Cameroon and Newcastle University, UK
name: Dr Sobngwi Eugene, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dep. of Physiologie, Faculty of Medicine and Biomedical Sciences University Yaoundé I, Cameroon
name: Dr Marcel Azabji Kenfack, MD
role: STUDY_CHAIR
affiliation: National Obesity Centre, Yaounde Central Hospital, Cameroon
name: Dr Gabriel Loni Ekali, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.3390/nu3070712. Epub 2011 Jul 18.