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Clinical Trial to Evaluate the Effect of an Extract of Sclerocaya Birrea on Prediabetic Subjects (PRED)

Primary Purpose

PreDiabetes

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Dietary Supplement: nutraceutical
Placebo
Sponsored by
Universidad Católica San Antonio de Murcia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for PreDiabetes

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Age: 18-65 years.

  • Diagnosis of prediabetes according to the American Diabetes Association.

    • Altered fasting glucose (95-125 mg / dl).
    • Glucose intolerance (oral glucose tolerance test with glycemia at 2 hours between 140 - 199 mg / dl).
    • Hemoglobin glycated between 5.7 and 6.4%.
  • Subjects with body mass index between 18-35 Kg / m2.
  • Stable food habits: there is no gain or weight loss of more than 5 kg in the ten weeks.
  • I do not consume foods rich in Screrocaria Birrea.

Exclusion Criteria:

  • Subjects with a history of any type of liver or kidney pathology.
  • Use of medications that may interfere with glucose metabolism.
  • Consumption of alcohol greater than 20 g / day.
  • History of allergic hypersensitivity or poor tolerance to any component of the products under study.
  • Participation in another clinical trial in the three months prior to the study
  • Lack of will or inability to comply with clinical trial procedures.
  • Pregnancy.

Sites / Locations

  • Catholic University of Murcia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Sclerocarya birrea

Placebo

Arm Description

Outcomes

Primary Outcome Measures

endothelial function
Changes in the dilatation of the Humeral artery.
blood samples
Changes in glycemic profile
Physical activity test
Change in physical activity with the World Physical Activity Questionnaire (GPAQ)
nutritional record
Potential changes in the dietary survey were controlled with a food diary
body composition
Changes in body composition were measured with a TANITA
glucose tolerance test
Venous blood samples are taken from the finger at different times.
blood samples
Changes in lipidic profile:( total cholesterol, HDL and LDL) , it will be measured in mg/dl.

Secondary Outcome Measures

Full Information

First Posted
April 19, 2018
Last Updated
December 11, 2019
Sponsor
Universidad Católica San Antonio de Murcia
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1. Study Identification

Unique Protocol Identification Number
NCT04132908
Brief Title
Clinical Trial to Evaluate the Effect of an Extract of Sclerocaya Birrea on Prediabetic Subjects
Acronym
PRED
Official Title
Clinical-nutritional Trial to Evaluate the Effect of an Extract of Sclerocaya Birrea on the Glycemic Profile in Prediabetic Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
October 1, 2016 (Actual)
Primary Completion Date
December 30, 2018 (Actual)
Study Completion Date
January 4, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Católica San Antonio de Murcia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
It consists in the intake, during a period of 10 weeks, of a nutraceutical (natural extract of Sclerocarya birrea). It is a clinical trial, during which certain parameters of the glucidic metabolism will be measured analytically. Other secondary variables such as lipid profile, inflammatory markers, blood pressure, endothelial function and body composition will also be determined.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PreDiabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sclerocarya birrea
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Dietary Supplement: nutraceutical
Intervention Description
Subjects will consume two capsules at breakfast and dinner for ten weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Subjects will consume two capsules at breakfast and dinner for ten weeks.
Primary Outcome Measure Information:
Title
endothelial function
Description
Changes in the dilatation of the Humeral artery.
Time Frame
The measurements of endothelial function are taken with an ultrasound on two different occasions. The measurements will be made at baseline and after ten weeks of product consumption. Up to 10 weeks
Title
blood samples
Description
Changes in glycemic profile
Time Frame
It is performed in the laboratory with the ILAB 600 analyzer. Blood samples are analyzed on two different occasions. The measurements are made at the beginning and after eight weeks of consumption of the product. Up to 10 weeks
Title
Physical activity test
Description
Change in physical activity with the World Physical Activity Questionnaire (GPAQ)
Time Frame
Quality of life measurements are taken with physical activity test on two different occasions. The measurements are made at the beginning and after ten weeks of consumption of the product. Up to 10 weeks
Title
nutritional record
Description
Potential changes in the dietary survey were controlled with a food diary
Time Frame
The dietary intake will be controlled by a diary in which meals will be recorded for three days and on two different occasions. The measurements are made at the beginning and after eight weeks of consumption of the product. Up to 10 weeks
Title
body composition
Description
Changes in body composition were measured with a TANITA
Time Frame
Body measurements are taken with a Tanita on two different occasions. The measurements are made at the beginning and after eight weeks of consumption of the product. Up to 10 weeks
Title
glucose tolerance test
Description
Venous blood samples are taken from the finger at different times.
Time Frame
The glucose measurements in venous blood are taken with a glucometer on three different occasions (1: at baseline before consumption of the product, 2: at five weeks and 3: ten weeks after ingestion of the layer product observe the changes) .
Title
blood samples
Description
Changes in lipidic profile:( total cholesterol, HDL and LDL) , it will be measured in mg/dl.
Time Frame
It is performed in the laboratory with the ILAB 600 analyzer. Blood samples are analyzed on two different occasions. The measurements are made at the beginning and after eight weeks of consumption of the product. Up to 10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age: 18-65 years. Diagnosis of prediabetes according to the American Diabetes Association. Altered fasting glucose (95-125 mg / dl). Glucose intolerance (oral glucose tolerance test with glycemia at 2 hours between 140 - 199 mg / dl). Hemoglobin glycated between 5.7 and 6.4%. Subjects with body mass index between 18-35 Kg / m2. Stable food habits: there is no gain or weight loss of more than 5 kg in the ten weeks. I do not consume foods rich in Screrocaria Birrea. Exclusion Criteria: Subjects with a history of any type of liver or kidney pathology. Use of medications that may interfere with glucose metabolism. Consumption of alcohol greater than 20 g / day. History of allergic hypersensitivity or poor tolerance to any component of the products under study. Participation in another clinical trial in the three months prior to the study Lack of will or inability to comply with clinical trial procedures. Pregnancy.
Facility Information:
Facility Name
Catholic University of Murcia
City
Murcia
ZIP/Postal Code
30107
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Clinical Trial to Evaluate the Effect of an Extract of Sclerocaya Birrea on Prediabetic Subjects

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