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

NCT04132908 | Completed DMC

• 1 other identifier: UCAMCFE-0006
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

PreDiabetes

Outcome Measures

Primary Outcomes (7)

• 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

Study Arms (2)

Sclerocarya birrea

EXPERIMENTAL

Dietary Supplement: Dietary Supplement: nutraceutical

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Placebo

Interventions

Dietary Supplement: nutraceutical DIETARY_SUPPLEMENT

Subjects will consume two capsules at breakfast and dinner for ten weeks.

Sclerocarya birrea

Placebo DIETARY_SUPPLEMENT

Subjects will consume two capsules at breakfast and dinner for ten weeks.

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Católica San Antonio de Murcia: lead

Study Sites (1)

Catholic University of Murcia

Murcia, 30107, Spain

Location

MeSH Terms

Conditions

Prediabetic State

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 19, 2018
• First Posted: October 21, 2019
• Study Start: October 1, 2016
• Primary Completion: December 30, 2018
• Study Completion: January 4, 2019
• Last Updated: December 13, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)