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

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

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.

Study Overview

• Status: Completed
• Conditions: PreDiabetes
• Intervention / Treatment: Dietary supplement: Dietary Supplement: nutraceutical; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Murcia, Spain, 30107
    • Catholic University of Murcia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Dietary supplement: Placebo; Subjects will consume two capsules at breakfast and dinner for ten weeks.
Experimental: Sclerocarya birrea	Dietary supplement: Dietary Supplement: nutraceutical; Subjects will consume two capsules at breakfast and dinner for ten weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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) .
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

Collaborators and Investigators

• Sponsor: Universidad Católica San Antonio de Murcia

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2016
• Primary Completion (Actual): December 30, 2018
• Study Completion (Actual): January 4, 2019

Study Registration Dates

• First Submitted: April 19, 2018
• First Submitted That Met QC Criteria: October 16, 2019
• First Posted (Actual): October 21, 2019

Study Record Updates

• Last Update Posted (Actual): December 13, 2019
• Last Update Submitted That Met QC Criteria: December 11, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Prediabetic State
• Other Study ID Numbers: UCAMCFE-0006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No