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RecruitingNCT07420998

Effect of a Nutritional Product Containing Carob Extract on Carbohydrate Metabolism in Glucose-intolerant Subjects

Randomized Clinical Trial on the Effect of a Nutritional Product Containing Carob Extract (NUTIFOOD) on Carbohydrate Metabolism in Glucose-intolerant Subjects

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
30 (estimated)
Sponsor
Universidad Católica San Antonio de Murcia · Academic / Other
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Accepted

Summary

Randomized, controlled, double-blind clinical trial with two parallel arms based on the product consumed (experimental product and placebo product) and conducted at a single center, to measure the efficacy of the liquid NUTIFOOD product (nutritional product with carob extract) on carbohydrate metabolism.

Detailed description

This study evaluates the effects of NUTIFOOD (liquid nutritional product with carob extract) on insulin sensitivity and carbohydrate metabolism in subjects with abnormal glucose or HbA1c levels not on antidiabetic medication, over 90 days. Key assessments include: Glucose response (AUC and peak levels) during an oral glucose tolerance test. Changes in fasting glucose, HbA1c, and basal insulin. Insulin resistance measured by HOMA-IR and QUICKI. Effects on body composition. Safety and tolerability of the product. The study aims to determine the potential of NUTIFOOD as a nutritional intervention to improve glucose regulation and metabolic health.

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTExperimental ProductParticipants will consume two doses per day. The product should be taken 30 minutes before the two main meals of the day.
DIETARY_SUPPLEMENTControl productParticipants will consume two daily doses of the placebo product. The product should be taken 30 minutes before the two main meals of the day.

Timeline

Start date
2026-01-26
Primary completion
2026-04-01
Completion
2026-07-01
First posted
2026-02-19
Last updated
2026-02-19

Locations

1 site across 1 country: Spain

Source: ClinicalTrials.gov record NCT07420998. Inclusion in this directory is not an endorsement.