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

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ClinicalTrials.gov Identifier: NCT01141777
Recruitment Status : Completed
First Posted : June 11, 2010
Last Update Posted : January 4, 2011
Sponsor:
Collaborators:
University of Yaounde
Antenna Technologies
Information provided by:
Yaounde Central Hospital

Tracking Information
First Submitted Date  ICMJE June 10, 2010
First Posted Date  ICMJE June 11, 2010
Last Update Posted Date January 4, 2011
Study Start Date  ICMJE October 2008
Actual Primary Completion Date February 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 24, 2010)
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) ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 10, 2010)
Percentage difference in insulin sensitivity within and between the two trial groups at the end of the study [ Time Frame: t=0 (baseline), t= week 12 (end of trial) ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 24, 2010)
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) ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 10, 2010)
Difference in body composition parameters within and between each group at the end of the study [ Time Frame: t=0 (baseline), t= week 12 (end of trial) ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effects of Spirulina Platensis on Insulin Resistance in HIV-infected Patients
Official Title  ICMJE The Effects of Spirulina Platensis on Insulin Resistance in HIV-infected Patients
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Insulin Resistance
  • HIV/AIDS
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Active Comparator: Spirulina platensis
    Intervention: Dietary Supplement: Spirulina platensis
  • Placebo Comparator: Soya bean
    Intervention: Dietary Supplement: Soya bean
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 10, 2010)
33
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2009
Actual Primary Completion Date February 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Cameroon
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01141777
Other Study ID Numbers  ICMJE MAK-GLE_Spirulina
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr Sobngwi Eugene, Consultant Endocrinologist and Senior Lecturer, University of Yaounde 1, Cameroon and Newcastle University, UK
Study Sponsor  ICMJE Yaounde Central Hospital
Collaborators  ICMJE
  • University of Yaounde
  • Antenna Technologies
Investigators  ICMJE
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
PRS Account Yaounde Central Hospital
Verification Date September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP