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
  Purpose

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


Condition Intervention
Insulin Resistance
HIV/AIDS
Dietary Supplement: Spirulina platensis
Dietary Supplement: Soya bean

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Official Title: The Effects of Spirulina Platensis on Insulin Resistance in HIV-infected Patients

Resource links provided by NLM:


Further study details as provided by Yaounde Central Hospital:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 33
Study Start Date: October 2008
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01141777

Locations
Cameroon
National Obesity Centre, Yaounde Central Hospital
Yaounde, Centre, Cameroon
Sponsors and Collaborators
Yaounde Central Hospital
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
  More Information

Additional Information:
No publications provided by Yaounde Central Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr Sobngwi Eugene, Consultant Endocrinologist and Senior Lecturer, University of Yaounde 1, Cameroon and Newcastle University, UK
ClinicalTrials.gov Identifier: NCT01141777     History of Changes
Other Study ID Numbers: MAK-GLE_Spirulina
Study First Received: June 10, 2010
Last Updated: January 3, 2011
Health Authority: Cameroon: Ministry of Public Health

Keywords provided by Yaounde Central Hospital:
Spirulina platensis
Insulin resistance
HIV/AIDS
HAART
Soya beans

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Insulin Resistance
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 01, 2014