The Effects of Spirulina Platensis on Insulin Resistance in HIV-infected Patients
Primary Purpose
Insulin Resistance, HIV/AIDS
Status
Completed
Phase
Not Applicable
Locations
Cameroon
Study Type
Interventional
Intervention
Spirulina platensis
Soya bean
Sponsored by
About this trial
This is an interventional supportive care trial for Insulin Resistance focused on measuring Spirulina platensis, Insulin resistance, HIV/AIDS, HAART, Soya beans
Eligibility 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
Sites / Locations
- National Obesity Centre, Yaounde Central Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Spirulina platensis
Soya bean
Arm Description
Outcomes
Primary Outcome Measures
Percentage difference in change in insulin sensitivity between the two groups at the end of eight weeks of intervention
Secondary Outcome Measures
Percentage of subjects who improved insulin sensitivity by the end of the study, compared between the two groups
Full Information
NCT ID
NCT01141777
First Posted
June 10, 2010
Last Updated
January 3, 2011
Sponsor
Yaounde Central Hospital
Collaborators
University of Yaounde, Antenna Technologies
1. Study Identification
Unique Protocol Identification Number
NCT01141777
Brief Title
The Effects of Spirulina Platensis on Insulin Resistance in HIV-infected Patients
Official Title
The Effects of Spirulina Platensis on Insulin Resistance in HIV-infected Patients
Study Type
Interventional
2. Study Status
Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
February 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Yaounde Central Hospital
Collaborators
University of Yaounde, Antenna Technologies
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insulin Resistance, HIV/AIDS
Keywords
Spirulina platensis, Insulin resistance, HIV/AIDS, HAART, Soya beans
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Spirulina platensis
Arm Type
Active Comparator
Arm Title
Soya bean
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Spirulina platensis
Other Intervention Name(s)
Treatment group
Intervention Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
Soya bean
Other Intervention Name(s)
Control group
Intervention Description
Each subject received 19g of supplement on average daily. Subjects were seen every two weeks to evaluate compliance and obtain a new stock.
Primary Outcome Measure Information:
Title
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)
Secondary Outcome Measure Information:
Title
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pr Jean Claude Mbanya, MD, PhD
Organizational Affiliation
International diabetes federation/ Director, National Obesity Centre, Yaounde Central Hospital, Cameroon
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Dr Sobngwi Eugene, MD, PhD
Organizational Affiliation
Consultant Endocrinologist, National Obesity Centre/ Senior Lecturer, University of Yaounde 1, Cameroon and Newcastle University, UK
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dr Marcel Azabji Kenfack, MD
Organizational Affiliation
Dep. of Physiologie, Faculty of Medicine and Biomedical Sciences University Yaoundé I, Cameroon
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Dr Gabriel Loni Ekali, MD
Organizational Affiliation
National Obesity Centre, Yaounde Central Hospital, Cameroon
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Obesity Centre, Yaounde Central Hospital
City
Yaounde
State/Province
Centre
Country
Cameroon
12. IPD Sharing Statement
Citations:
PubMed Identifier
22254118
Citation
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.
Results Reference
derived
Links:
URL
http://www.nlm.nih.gov/medlineplus/
Description
MedlinePlus
URL
http://clinicaltrials.gov/ct2/info/fdalinks
Description
U.S FDA Resources
Learn more about this trial
The Effects of Spirulina Platensis on Insulin Resistance in HIV-infected Patients
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