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Completed

NCT Number: NCT04132908

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

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Key information

Conditions

PreDiabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Prediabetic State

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Catholic University of Murcia

Murcia, 30107, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dietary Supplement: nutraceutical

Dietary Supplement

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

Placebo

Dietary Supplement

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

Primary outcomes

  1. endothelial function

    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

    Changes in the dilatation of the Humeral artery.

  2. blood samples

    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

    Changes in glycemic profile

  3. Physical activity test

    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

    Change in physical activity with the World Physical Activity Questionnaire (GPAQ)

  4. nutritional record

    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

    Potential changes in the dietary survey were controlled with a food diary

  5. body composition

    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

    Changes in body composition were measured with a TANITA

  6. glucose tolerance test

    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) .

    Venous blood samples are taken from the finger at different times.

  7. blood samples

    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

    Changes in lipidic profile:( total cholesterol, HDL and LDL) , it will be measured in mg/dl.

Sponsors and collaborators

Lead sponsor

Universidad Católica San Antonio de Murcia

Other

Registry information

Official study title

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

Acronym: PRED

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
Oct 21, 2019
Registry last updated
Dec 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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