The Effects of Spirulina Platensis on Insulin Resistance in HIV-infected Patients
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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 |
- 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 ]
- 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 |
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| Cameroon | |
| National Obesity Centre, Yaounde Central Hospital | |
| Yaounde, Centre, Cameroon | |
| 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 Insulin Resistance HIV Infections 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 March 07, 2013
