NCT01141777

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2008

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

June 10, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 11, 2010

Completed
Last Updated

January 4, 2011

Status Verified

September 1, 2010

Enrollment Period

4 months

First QC Date

June 10, 2010

Last Update Submit

January 3, 2011

Conditions

Insulin ResistanceHIV/AIDS

Keywords

Spirulina platensisInsulin resistanceHIV/AIDSHAARTSoya beans

Outcome Measures

Primary Outcomes (1)

  • Percentage difference in change in insulin sensitivity between the two groups at the end of eight weeks of intervention

    t=0 (baseline), t= week 12 (end of trial)

Secondary Outcomes (1)

  • Percentage of subjects who improved insulin sensitivity by the end of the study, compared between the two groups

    t=0 (baseline), t= week 12 (end of trial)

Study Arms (2)

Spirulina platensis

ACTIVE COMPARATOR
Dietary Supplement: Spirulina platensis

Soya bean

PLACEBO COMPARATOR
Dietary Supplement: Soya bean

Interventions

Spirulina platensisDIETARY_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

Also known as: Treatment group
Spirulina platensis
Soya beanDIETARY_SUPPLEMENT

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

Also known as: Control group
Soya bean

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Confirmed HIV infection
  • Accepted to participate in the study

You may not qualify if:

  • Acute intercurrent infection
  • Treatment that modifies glucose or lipid profile
  • Pregnancy
  • Known diabetic patient
  • Chronic renal failure with calculated creatinine clearance \< 60ml/min

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Obesity Centre, Yaounde Central Hospital

Yaoundé, Centre Region, Cameroon

Location

Related Publications (1)

  • 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.

    PMID: 22254118DERIVED

Related Links

MeSH Terms

Conditions

Insulin ResistanceAcquired Immunodeficiency Syndrome

Interventions

Soybean OilControl Groups

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesHIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

Dietary Fats, UnsaturatedDietary FatsFatsLipidsFats, UnsaturatedPlant OilsOilsPlant PreparationsBiological ProductsComplex MixturesFoodDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesEpidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Pr Jean Claude Mbanya, MD, PhD

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

    STUDY DIRECTOR

  • Dr Sobngwi Eugene, MD, PhD

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

    PRINCIPAL INVESTIGATOR

  • Dr Marcel Azabji Kenfack, MD

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

    STUDY CHAIR

  • Dr Gabriel Loni Ekali, MD

    National Obesity Centre, Yaounde Central Hospital, Cameroon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

June 10, 2010

First Posted

June 11, 2010

Study Start

October 1, 2008

Primary Completion

February 1, 2009

Study Completion

February 1, 2009

Last Updated

January 4, 2011

Record last verified: 2010-09

Locations

CA(1)