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

NCT ID: NCT01141777

Last Updated: 2011-01-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2009-02-28

Brief Summary

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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

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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.

Conditions

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Insulin Resistance HIV/AIDS

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Spirulina platensis

Group Type ACTIVE_COMPARATOR

Spirulina platensis

Intervention Type DIETARY_SUPPLEMENT

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

Soya bean

Group Type PLACEBO_COMPARATOR

Soya bean

Intervention Type DIETARY_SUPPLEMENT

Each subject received 19g of supplement on average daily. Subjects were seen every two weeks to evaluate compliance and obtain a new stock.

Interventions

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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

Intervention Type 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.

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Treatment group Control group

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Yaounde

OTHER

Sponsor Role collaborator

Antenna Technologies

UNKNOWN

Sponsor Role collaborator

Yaounde Central Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Consultant Endocrinologist and Senior Lecturer, University of Yaounde 1, Cameroon and Newcastle University, UK

Principal Investigators

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Pr Jean Claude Mbanya, MD, PhD

Role: STUDY_DIRECTOR

International diabetes federation/ Director, National Obesity Centre, Yaounde Central Hospital, Cameroon

Dr Sobngwi Eugene, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Consultant Endocrinologist, National Obesity Centre/ Senior Lecturer, University of Yaounde 1, Cameroon and Newcastle University, UK

Dr Marcel Azabji Kenfack, MD

Role: STUDY_CHAIR

Dep. of Physiologie, Faculty of Medicine and Biomedical Sciences University Yaoundé I, Cameroon

Dr Gabriel Loni Ekali, MD

Role: PRINCIPAL_INVESTIGATOR

National Obesity Centre, Yaounde Central Hospital, Cameroon

Locations

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National Obesity Centre, Yaounde Central Hospital

Yaoundé, Centre Region, Cameroon

Site Status

Countries

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Cameroon

References

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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.

Reference Type DERIVED
PMID: 22254118 (View on PubMed)

Related Links

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Other Identifiers

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MAK-GLE_Spirulina

Identifier Type: -

Identifier Source: org_study_id

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