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

January 3, 2011 updated by: Yaounde Central Hospital
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

33

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Cameroon
    • Centre
      • Yaounde, Centre, Cameroon
        • National Obesity Centre, Yaounde Central Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • Control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
t=0 (baseline), t= week 12 (end of trial)

Secondary Outcome Measures

Outcome Measure
Time Frame
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)
t=0 (baseline), t= week 12 (end of trial)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yaounde Central Hospital

Collaborators

University of Yaounde
Antenna Technologies

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (Actual)

February 1, 2009

Study Completion (Actual)

February 1, 2009

Study Registration Dates

First Submitted

June 10, 2010

First Submitted That Met QC Criteria

June 10, 2010

First Posted (Estimate)

June 11, 2010

Study Record Updates

Last Update Posted (Estimate)

January 4, 2011

Last Update Submitted That Met QC Criteria

January 3, 2011

Last Verified

September 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MAK-GLE_Spirulina

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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