Brief 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. 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.

Trial Health

On Track

Trial Health Score

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

Enrollment

125

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started Oct 2008

Shorter than P25 for phase_2

Geographic Reach

1 country

2 active sites

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

5 months study duration

Study Start

First participant enrolled

October 1, 2008

Completed

2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed

3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed

3 months until next milestone

First Submitted

Initial submission to the registry

June 8, 2009

Completed

1 day until next milestone

First Posted

Study publicly available on registry

June 9, 2009

Completed

Last Updated

December 2, 2016

Status Verified

July 1, 2009

Enrollment Period

2 months

First QC Date

June 8, 2009

Last Update Submit

December 1, 2016

Conditions

Metabolic Syndrome

Keywords

hyperglycemiaoverweightfunctional foodaloe veracnidoscolus chayamansa

Outcome Measures

Primary Outcomes (1)

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%.
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.
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.
after each week taking the product

Study Arms (6)

P1&P2

PLACEBO COMPARATOR

Food product P1\&P2 is composed of: placebo1(mimic aloe vera gel) 30ml and placebo2 (mimic Cnidoscolus chayamansa infusion) 200ml;

Dietary Supplement: P1&P2

P1&CC

EXPERIMENTAL

Food Product P1\&CC contains: placebo1 (mimics liquified aloe vera gel) 30ml and Cnidoscolus Chayamansa infusion 200ml;

Dietary Supplement: P1&CC

AG&P2

EXPERIMENTAL

Food product AG\&P2 contains (liquified aloe vera gel) 30ml and placebo2 (mimic CC infusion) 200ml.

Dietary Supplement: AG&P2

AG&CC

EXPERIMENTAL

Food product AG\&CC is composed of: liquified aloe vera gel 30ml and Cnidoscolus Chayamansa infusion 200ml

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.

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.

Dietary Supplement: P3

Interventions

P1&P2DIETARY_SUPPLEMENT

* 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

Also known as: Placebo 1 and Placebo 2

P1&P2

P1&CCDIETARY_SUPPLEMENT

* 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.

Also known as: Placebo 1 and Cnidoscolus Chayamansa infusion

P1&CC

AG&P2DIETARY_SUPPLEMENT

* 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

Also known as: Aloe Vera Gel and Placebo 2

AG&P2

AG&CCDIETARY_SUPPLEMENT

* 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

Also known as: Aloe Vera gel and Cnidoscolus Chayamansa infusion, Sabila & Chaya infusion

AG&CC

TA (concentrated 5:1 aloe vera gel)DIETARY_SUPPLEMENT

* 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.

Also known as: Total Aloe concentrated 5:1 aloe vera gel by total process

TA (concentrated 5:1 aloe vera gel)

P3DIETARY_SUPPLEMENT

* 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.

Also known as: Placebo 3

Eligibility Criteria

Age20 Years - 70 Years

Sexfemale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

Pregnancy or nursing
On anti-diabetic agents
Diabetic symptoms or advanced DM complications
Severe behavioral problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Universidad Autonoma de Nuevo Leonlead

Study Sites (2)

Fomerrey 19 Community Clinic

Guadalupe, Nuevo León, Mexico

Location

Endocrinology, Outpatient clinic of University Hospital UANL

Monterrey, Nuevo León, 54460, Mexico

Location

MeSH Terms

Conditions

Metabolic SyndromeHyperglycemiaOverweight

Interventions

Aloe vera gel

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

Lilia Cardenas-Ibarra, MD
Endocrinology, University Hospital, Universidad Autonoma de Nuevo Leon
PRINCIPAL INVESTIGATOR
Jesus Z Villarreal-Perez, MD
Endocrinology, University Hospital, Universidad Autonoma de Nuevo Leon
STUDY CHAIR

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: TRIPLE
Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: CROSSOVER
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: MD

Study Record Dates

First Submitted

June 8, 2009

First Posted

June 9, 2009

Study Start

October 1, 2008

Primary Completion

December 1, 2008

Study Completion

March 1, 2009

Last Updated

December 2, 2016

Record last verified: 2009-07

Locations

ME(2)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (6)

P1&P2

P1&CC

AG&P2

AG&CC

TA (concentrated 5:1 aloe vera gel)

P3

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Locations