Insulin ResistanceNCT01141777
The Effects of Spirulina Platensis on Insulin Resistance in HIV-infected Patients
A study testing Spirulina platensis and Soya bean in people with Insulin Resistance and HIV/AIDS, run by Yaounde Central Hospital at 1 site in Cameroon.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Insulin Resistance, HIV/AIDS
- What is being tested?
- Spirulina platensis and Soya bean
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 siteCameroon
- Study dates
- Oct 2008to Feb 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed HIV infection
- Accepted to participate in the study
Who cannot join
- Acute intercurrent infection
- Treatment that modifies glucose or lipid profile
- Pregnancy
- Known diabetic patient
- Chronic renal failure with calculated creatinine clearance < 60ml/min
Trial locations and contacts
1 site in 1 country.
Cameroon1 site
National Obesity Centre, Yaounde Central Hospital
Yaoundé, Centre Region
About this study
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
Read the 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.
- Conditions
- Insulin Resistance, HIV/AIDS
- Being tested
- Spirulina platensis, Soya bean
- Keywords
- Spirulina platensis, Insulin resistance, HIV/AIDS, HAART, Soya beans
- Medical subject headings
- Insulin Resistance, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spirulina platensisDietary supplement
Also called Treatment group
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 beanDietary supplement
Also called Control group
Each subject received 19g of supplement on average daily. Subjects were seen every two weeks to evaluate compliance and obtain a new stock.
| Study group | Role | What they receive |
|---|---|---|
| Spirulina platensis | Active comparator | Not described Receives: Dietary Supplement: Spirulina platensis |
| Soya bean | Placebo comparator | Not described Receives: Dietary Supplement: Soya bean |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage difference in change in insulin sensitivity between the two groups at the end of eight weeks of intervention
Measured: 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
Measured: t=0 (baseline), t= week 12 (end of trial)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2010 (estimated)
- Study startOct 2008
- Primary completionFeb 2009
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Insulin ResistanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yaounde Central Hospital
- Sponsor type
- Other government
- Collaborators
- University of Yaounde, Antenna Technologies
- Investigators
- Pr Jean Claude Mbanya, MD, PhD, Study director, International diabetes federation/ Director, National Obesity Centre, Yaounde Central Hospital, CameroonDr Sobngwi Eugene, MD, PhD, Principal investigator, Consultant Endocrinologist, National Obesity Centre/ Senior Lecturer, University of Yaounde 1, Cameroon and Newcastle University, UKDr Marcel Azabji Kenfack, MD, Study chair, Dep. of Physiologie, Faculty of Medicine and Biomedical Sciences University Yaoundé I, CameroonDr Gabriel Loni Ekali, MD, Principal investigator, National Obesity Centre, Yaounde Central Hospital, Cameroon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01141777
- Sponsor's protocol ID
- MAK-GLE_Spirulina
- Status last verified
- Sep 2010
- First submitted
- 10 Jun 2010
- Last updated
- 4 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 22254118
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Spirulina Platensis on Insulin Resistance in HIV-infected Patients
- ClinicalTrials.gov ID
- NCT01141777
- Acronym / sponsor ID
- MAK-GLE_Spirulina
- Conditions
- Insulin Resistance, HIV/AIDS
- Keywords
- Spirulina platensis, Insulin resistance, HIV/AIDS, HAART, Soya beans
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Yaounde Central HospitalOther government
- Collaborators
- University of Yaounde, Antenna Technologies
- Study start
- Oct 2008
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 11 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spirulina platensis | Active comparator | Dietary Supplement: Spirulina platensis |
| Soya bean | Placebo comparator | Dietary Supplement: Soya bean |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Confirmed HIV infection
- Accepted to participate in the study
Key exclusion criteria (5 listed)
- Acute intercurrent infection
- Treatment that modifies glucose or lipid profile
- Pregnancy
- Known diabetic patient
- Chronic renal failure with calculated creatinine clearance < 60ml/min
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spirulina platensisAlso: Treatment groupSubjects 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 | Dietary supplement | Spirulina platensis |
| Soya beanAlso: Control groupEach subject received 19g of supplement on average daily. Subjects were seen every two weeks to evaluate compliance and obtain a new stock. | Dietary supplement | Soya bean |
Primary outcome
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)
1 secondary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2011.
- Derived from this study: PubMed 22254118Marcel 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.
- MedlinePlusLink provided by the sponsor.
- U.S FDA ResourcesLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pr Jean Claude Mbanya, MD, PhD study director
International diabetes federation/ Director, National Obesity Centre, Yaounde Central Hospital, Cameroon
Dr Sobngwi Eugene, MD, PhD principal investigator
Consultant Endocrinologist, National Obesity Centre/ Senior Lecturer, University of Yaounde 1, Cameroon and Newcastle University, UK
Dr Marcel Azabji Kenfack, MD study chair
Dep. of Physiologie, Faculty of Medicine and Biomedical Sciences University Yaoundé I, Cameroon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spirulina platensis and Soya bean in people with Insulin Resistance and HIV/AIDS, run by Yaounde Central Hospital at 1 site in Cameroon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Cameroon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01141777, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2011; AzTrials last refreshed its copy on 8 Nov 2026.