NCT04132908: PRED

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

Completed NA Last updated 13 December 2019

What this trial tests

NA trial testing Dietary Supplement: nutraceutical in PreDiabetes in 70 participants. Completed in 4 January 2019.

Timeline

1 October 2016

Primary endpoint
30 December 2018

4 January 2019

Quick facts

Lead sponsor	Universidad Católica San Antonio de Murcia
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	70
Start date	1 October 2016
Primary completion	30 December 2018
Estimated completion	4 January 2019
Sites	1 location across Spain

Drugs / interventions tested

• Dietary Supplement: nutraceutical
• Placebo

Conditions studied

• PreDiabetes — all drugs for PreDiabetes →

Sponsor

Universidad Católica San Antonio de Murcia

Who can join

Adults 18 to 75, any sex, with PreDiabetes. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Effect of Dietary Supplementation with a Natural Extract of <i>Sclerocarya birrea</i> on Glycemic Metabolism in Subjects with Prediabetes: A Randomized Double-Blind Placebo-Controlled Study.
   Victoria-Montesinos D, Sánchez-Macarro M, Gabaldón-Hernández JA, Abellán-Ruiz MS, et al · · 2021 · cited 8× · PMID 34204042 · DOI 10.3390/nu13061948