Metabolic SyndromePhase 2/3NCT00916175
Metabolic Syndrome and Functional Food
A Phase 2/3 study testing P1&P2, P1&CC and AG&P2 in people with Metabolic Syndrome, run by Universidad Autonoma de Nuevo Leon at 2 sites in Mexico.
Trial summary
High blood sugar and adiposity are part of Metabolic syndrome (about 24% of adults harbor it). The main approach, weight reduction, is often unattainable. Aloe Vera (barbadensis) (AV) and cnidoscolus chayamansa (McVaugh)(CC) are two vegetables that seem to have an effect on blood glucose and body weight. Read more about this study
- Who is it for?
- Ages 20 to 70 years, women only
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- P1&P2, P1&CC and AG&P2
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 125 participants
- Where
- 2 sitesMexico
- Study dates
- Oct 2008to Mar 2009
- Phase
- Phase 2/3
- 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 20 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult women living in Monterrey, Mexico with at least three of the following:
- waist line equal or larger than 88 cm
- fasting blood sugar between 100-140 mg/dL without symptoms or known glucose intolerance or diabetes treated only with diet
- known high blood pressure or 2/3 readings systolic > 130 mmHg, diastolic > 85
- HLD < 50 mg/dL or triglycerides > 150 mg/dL
Who cannot join
- Pregnancy or nursing
- On anti-diabetic agents
- Diabetic symptoms or advanced DM complications
- Severe behavioral problems
Trial locations and contacts
2 sites in 1 country.
Mexico2 sites
Fomerrey 19 Community Clinic
Guadalupe, Nuevo León
Endocrinology, Outpatient clinic of University Hospital UANL
Monterrey, Nuevo León, 54460
About this study
Official title: Randomized Double Blind Factorial Assay, Aloe Vera (AV) And/Or Cnidoscolus Chayamansa (CC) Versus Placebo, Reduction Of High Blood Glucose In Women With Metabolic Syndrome
High blood sugar and adiposity are part of Metabolic syndrome (about 24% of adults harbor it). The main approach, weight reduction, is often unattainable. Aloe Vera (barbadensis) (AV) and cnidoscolus chayamansa (McVaugh)(CC) are two vegetables that seem to have an effect on blood glucose and body weight.
The study aims to determine if the intake of aloe gel and/or Chaya infusion can reduce high blood sugar in adult women with pre-diabetes (Metabolic Syndrome).
Read more
Methods: A Factorial assay, double blind, cross-over-controlled with random assignment, to four treatments: AV and CC, AV and Placebo 1, Placebo 2 and CC, and Placebo 1 and Placebo 2, at the outpatient clinic of the university Hospital and a community clinic.
Two treatment periods of 4 weeks intermediated by one week for wash-out.
- Conditions
- Metabolic Syndrome
- Being tested
- P1&P2, P1&CC, AG&P2, AG&CC, TA (concentrated 5:1 aloe vera gel)
- Keywords
- hyperglycemia, overweight, functional food, aloe vera, cnidoscolus chayamansa
- Medical subject headings
- Metabolic Syndrome, Hyperglycemia, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
P1&P2Dietary supplement
Also called Placebo 1 and Placebo 2
- First period (4 weeks) intake food product P1\&P2 (in lemon gelatin 230 ml before breakfast) plus 1500 kilo calories diet
- Second period, cross over from AG\&CC group, 4 weeks intake food product P1\&P2 (in lemon gelatin 230 ml before breakfast and 230 ml after supper) plus 1500 kilo calories diet
P1&CCDietary supplement
Also called Placebo 1 and Cnidoscolus Chayamansa infusion
- First period (4 weeks) intake food product P1\&CC (in lemon gelatin 230 ml before breakfast) plus 1500 kilo calories diet.
- Second period, cross over from AG\&P2 group, 4 weeks intake food product P1\&CC (in lemon gelatin 230 ml before breakfast and 230 ml after supper) plus 1500 kilo calories diet.
AG&P2Dietary supplement
Also called Aloe Vera Gel and Placebo 2
- First period (4 weeks) intake food product AG\&P2 (in lemon gelatin 230 ml before breakfast) plus 1500 kilo calories diet.
- Second period, cross over from P1\&CC group, 4 weeks intake food product AG\&P2 (in lemon gelatin 230 ml before breakfast and 230 ml after supper) plus 1500 kilo calories diet
AG&CCDietary supplement
Also called Aloe Vera gel and Cnidoscolus Chayamansa infusion, Sabila & Chaya infusion
- First period (4 weeks) intake food product AG\&CC (in lemon gelatin 230 ml before breakfast) plus 1500 kilo calories diet
- Second period, cross over from P1\&P2 group, 4 weeks intake food product AG\&CC (in lemon gelatin 230 ml before breakfast and 230 ml after supper) plus 1500 kilo calories diet
TA (concentrated 5:1 aloe vera gel)Dietary supplement
Also called Total Aloe concentrated 5:1 aloe vera gel by total process
- First period (4 weeks) intake food product TA (in lemon gelatin 230 ml before breakfast) plus 1500 kilo calories diet.
- Second period, cross over from P3 group, 4 weeks intake food product TA (in lemon gelatin 230 ml before breakfast and 230 ml after supper) plus 1500 kilo calories diet.
P3Dietary supplement
Also called Placebo 3
- First period (4 weeks) intake food product P3 (in lemon gelatin 230 ml before breakfast) plus 1500 kilo calories diet.
- Second period, cross over from TA group, 4 weeks intake food product P3 (in lemon gelatin 230 ml before breakfast and 230 ml after supper) plus 1500 kilo calories diet.
| Study group | Role | What they receive |
|---|---|---|
| P1&P2 | Placebo comparator | Food product P1\&P2 is composed of: placebo1(mimic aloe vera gel) 30ml and placebo2 (mimic Cnidoscolus chayamansa infusion) 200ml; Receives: Dietary Supplement: P1&P2 |
| P1&CC | Experimental | Food Product P1\&CC contains: placebo1 (mimics liquified aloe vera gel) 30ml and Cnidoscolus Chayamansa infusion 200ml; Receives: Dietary Supplement: P1&CC |
| AG&P2 | Experimental | Food product AG\&P2 contains (liquified aloe vera gel) 30ml and placebo2 (mimic CC infusion) 200ml. Receives: Dietary Supplement: AG&P2 |
| AG&CC | Experimental | Food product AG\&CC is composed of: liquified aloe vera gel 30ml and Cnidoscolus Chayamansa infusion 200ml Receives: Dietary Supplement: AG&CC |
| TA (concentrated 5:1 aloe vera gel) | Experimental | Food product TA contains concentrated 5:1 aloe vera gel by total process30 ml and purified water 200 ml. Receives: Dietary Supplement: TA (concentrated 5:1 aloe vera gel) |
| P3 | Placebo comparator | Food product Placebo 3 contains stabilizers and preservative used for TA 30 ml and purified water 200 ml. Receives: Dietary Supplement: P3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of elevated blood sugar (HbA1c) by Immunoturbidimetric test (One-HbA1c FS) via Star-Dust MC15; both from Diagnostic systems international (DiaSys); its coefficient of variation was 1.6%.
Measured: baseline, and at the end of each of 2 treatment periods of 4 weeks
Secondary outcomes (2)
Significant changes on hematic biometry and liver function test and evaluation of any symptoms reported.
Measured: baseline, and after four weeks of treatment or sooner if needed
Tolerance assessed by weekly inquiry of effort needed to take the product, wellbeing, energy, gastrointestinal complains, control of appetite and general complaints.
Measured: after each week taking the product
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2009 (estimated)
- Study startOct 2008
- Primary completionDec 2008
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Autonoma de Nuevo Leon
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lilia Csrdenas-Ibarra, Universidad Autonoma de Nuevo Leon
- Investigators
- Lilia Cardenas-Ibarra, MD, Principal investigator, Endocrinology, University Hospital, Universidad Autonoma de Nuevo LeonJesus Z Villarreal-Perez, MD, Study chair, Endocrinology, University Hospital, Universidad Autonoma de Nuevo Leon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00916175
- Sponsor's protocol ID
- EN_LC_P134
- Status last verified
- Jul 2009
- First submitted
- 8 Jun 2009
- Last updated
- 2 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Double Blind Factorial Assay, Aloe Vera (AV) And/Or Cnidoscolus Chayamansa (CC) Versus Placebo, Reduction Of High Blood Glucose In Women With Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT00916175
- Acronym / sponsor ID
- EN_LC_P134
- Conditions
- Metabolic Syndrome
- Keywords
- hyperglycemia, overweight, functional food, aloe vera, cnidoscolus chayamansa
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Universidad Autonoma de Nuevo LeonUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 9 Jun 2009 (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.
High blood sugar and adiposity are part of Metabolic syndrome (about 24% of adults harbor it). The main approach, weight reduction, is often unattainable. Aloe Vera (barbadensis) (AV) and cnidoscolus chayamansa (McVaugh)(CC) are two vegetables that seem to have an effect on blood glucose and body weight.
The study aims to determine if the intake of aloe gel and/or Chaya infusion can reduce high blood sugar in adult women with pre-diabetes (Metabolic Syndrome).
Methods: A Factorial assay, double blind, cross-over-controlled with random assignment, to four treatments: AV and CC, AV and Placebo 1, Placebo 2 and CC, and Placebo 1 and Placebo 2, at the outpatient clinic of the university Hospital and a community clinic.
Two treatment periods of 4 weeks intermediated by one week for wash-out.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| P1&P2 | Placebo comparator | Dietary Supplement: P1&P2Food product P1\&P2 is composed of: placebo1(mimic aloe vera gel) 30ml and placebo2 (mimic Cnidoscolus chayamansa infusion) 200ml; |
| P1&CC | Experimental | Dietary Supplement: P1&CCFood Product P1\&CC contains: placebo1 (mimics liquified aloe vera gel) 30ml and Cnidoscolus Chayamansa infusion 200ml; |
| AG&P2 | Experimental | Dietary Supplement: AG&P2Food product AG\&P2 contains (liquified aloe vera gel) 30ml and placebo2 (mimic CC infusion) 200ml. |
| AG&CC | Experimental | Dietary Supplement: AG&CCFood product AG\&CC is composed of: liquified aloe vera gel 30ml and Cnidoscolus Chayamansa infusion 200ml |
| TA (concentrated 5:1 aloe vera gel) | Experimental | Dietary Supplement: TA (concentrated 5:1 aloe vera gel)Food product TA contains concentrated 5:1 aloe vera gel by total process30 ml and purified water 200 ml. |
| P3 | Placebo comparator | Dietary Supplement: P3Food product Placebo 3 contains stabilizers and preservative used for TA 30 ml and purified water 200 ml. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult women living in Monterrey, Mexico with at least three of the following:
Key exclusion criteria (4 listed)
- Pregnancy or nursing
- On anti-diabetic agents
- Diabetic symptoms or advanced DM complications
- Severe behavioral problems
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 |
|---|---|---|
| P1&P2Also: Placebo 1 and Placebo 2* First period (4 weeks) intake food product P1\&P2 (in lemon gelatin 230 ml before breakfast) plus 1500 kilo calories diet * Second period, cross over from AG\&CC group, 4 weeks intake food product P1\&P2 (in lemon gelatin 230 ml before breakfast and 230 ml after supper) plus 1500 kilo calories diet | Dietary supplement | P1&P2 |
| P1&CCAlso: Placebo 1 and Cnidoscolus Chayamansa infusion* First period (4 weeks) intake food product P1\&CC (in lemon gelatin 230 ml before breakfast) plus 1500 kilo calories diet. * Second period, cross over from AG\&P2 group, 4 weeks intake food product P1\&CC (in lemon gelatin 230 ml before breakfast and 230 ml after supper) plus 1500 kilo calories diet. | Dietary supplement | P1&CC |
| AG&P2Also: Aloe Vera Gel and Placebo 2* First period (4 weeks) intake food product AG\&P2 (in lemon gelatin 230 ml before breakfast) plus 1500 kilo calories diet. * Second period, cross over from P1\&CC group, 4 weeks intake food product AG\&P2 (in lemon gelatin 230 ml before breakfast and 230 ml after supper) plus 1500 kilo calories diet | Dietary supplement | AG&P2 |
| AG&CCAlso: Aloe Vera gel and Cnidoscolus Chayamansa infusion, Sabila & Chaya infusion* First period (4 weeks) intake food product AG\&CC (in lemon gelatin 230 ml before breakfast) plus 1500 kilo calories diet * Second period, cross over from P1\&P2 group, 4 weeks intake food product AG\&CC (in lemon gelatin 230 ml before breakfast and 230 ml after supper) plus 1500 kilo calories diet | Dietary supplement | AG&CC |
| TA (concentrated 5:1 aloe vera gel)Also: Total Aloe concentrated 5:1 aloe vera gel by total process* First period (4 weeks) intake food product TA (in lemon gelatin 230 ml before breakfast) plus 1500 kilo calories diet. * Second period, cross over from P3 group, 4 weeks intake food product TA (in lemon gelatin 230 ml before breakfast and 230 ml after supper) plus 1500 kilo calories diet. | Dietary supplement | TA (concentrated 5:1 aloe vera gel) |
| P3Also: Placebo 3* First period (4 weeks) intake food product P3 (in lemon gelatin 230 ml before breakfast) plus 1500 kilo calories diet. * Second period, cross over from TA group, 4 weeks intake food product P3 (in lemon gelatin 230 ml before breakfast and 230 ml after supper) plus 1500 kilo calories diet. | Dietary supplement | P3 |
Primary outcome
Reduction of elevated blood sugar (HbA1c) by Immunoturbidimetric test (One-HbA1c FS) via Star-Dust MC15; both from Diagnostic systems international (DiaSys); its coefficient of variation was 1.6%.
Time frame: baseline, and at the end of each of 2 treatment periods of 4 weeks
2 secondary outcomes
Significant changes on hematic biometry and liver function test and evaluation of any symptoms reported.
Time frame: baseline, and after four weeks of treatment or sooner if needed
Tolerance assessed by weekly inquiry of effort needed to take the product, wellbeing, energy, gastrointestinal complains, control of appetite and general complaints.
Time frame: after each week taking the product
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 2 Dec 2016.
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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.
Lilia Cardenas-Ibarra, MD principal investigator
Endocrinology, University Hospital, Universidad Autonoma de Nuevo Leon
Jesus Z Villarreal-Perez, MD study chair
Endocrinology, University Hospital, Universidad Autonoma de Nuevo Leon
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing P1&P2, P1&CC and AG&P2 in people with Metabolic Syndrome, run by Universidad Autonoma de Nuevo Leon at 2 sites in Mexico.
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 5 inclusion and 4 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 2 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Mexico. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Reduction of elevated blood sugar (HbA1c) by Immunoturbidimetric test (One-HbA1c FS) via Star-Dust MC15; both from Diagnostic systems international (DiaSys); its coefficient of variation was 1.6%. (time frame: baseline, and at the end of each of 2 treatment periods of 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Dec 2016; AzTrials last refreshed its copy on 6 Nov 2026.