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

PreDiabetes Clinical Trial

— PRED  

Official title:

Clinical-nutritional Trial to Evaluate the Effect of an Extract of Sclerocaya Birrea on the Glycemic Profile in Prediabetic Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04132908
• Other study ID #: UCAMCFE-0006
• Status: Completed
• Phase: N/A
• Start date: October 1, 2016
• Est. completion date: January 4, 2019

Study information

• Verified date: December 2019
• Source: Universidad Católica San Antonio de Murcia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: January 4, 2019
• Est. primary completion date: December 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• PreDiabetes
• Prediabetic State

Intervention

Dietary Supplement:
• Dietary Supplement: nutraceutical
Subjects will consume two capsules at breakfast and dinner for ten weeks.
• Placebo
Subjects will consume two capsules at breakfast and dinner for ten weeks.

Locations

Country	Name	City	State
Spain	Catholic University of Murcia	Murcia

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Católica San Antonio de Murcia

Country where clinical trial is conducted

Spain, 

Outcome

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