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

Insulin Resistance Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01141777
• Other study ID #: MAK-GLE_Spirulina
• Status: Completed
• Phase: N/A
• First received: June 10, 2010
• Last updated: January 3, 2011
• Start date: October 2008
• Est. completion date: February 2009

Study information

• Verified date: September 2010
• Source: Yaounde Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Cameroon: Ministry of Public Health
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• HIV/AIDS
• Insulin Resistance

Intervention

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
• 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.

Locations

Country	Name	City	State
Cameroon	National Obesity Centre, Yaounde Central Hospital	Yaounde	Centre

Sponsors (3)

Lead Sponsor	Collaborator
Yaounde Central Hospital	Antenna Technologies, University of Yaounde

Country where clinical trial is conducted

Cameroon, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage difference in change in insulin sensitivity between the two groups at the end of eight weeks of intervention		t=0 (baseline), t= week 12 (end of trial)	No
Secondary	Percentage of subjects who improved insulin sensitivity by the end of the study, compared between the two groups		t=0 (baseline), t= week 12 (end of trial)	No

External Links

•   MedlinePlus
•   U.S FDA Resources