The Effects of Spirulina Platensis on Insulin Resistance in HIV-infected Patients
|ClinicalTrials.gov Identifier: NCT01141777|
Recruitment Status : Completed
First Posted : June 11, 2010
Last Update Posted : January 4, 2011
|Condition or disease||Intervention/treatment||Phase|
|Insulin Resistance HIV/AIDS||Dietary Supplement: Spirulina platensis Dietary Supplement: Soya bean||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||33 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Primary Purpose:||Supportive Care|
|Official Title:||The Effects of Spirulina Platensis on Insulin Resistance in HIV-infected Patients|
|Study Start Date :||October 2008|
|Actual Primary Completion Date :||February 2009|
|Actual Study Completion Date :||February 2009|
|Active Comparator: Spirulina platensis||
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
|Placebo Comparator: Soya bean||
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
- 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) ]
- 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) ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01141777
|National Obesity Centre, Yaounde Central Hospital|
|Yaounde, Centre, Cameroon|
|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|