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Recruiting NCT07420998

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

No phase Interventional Prediabetes

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Experimental Product, Control product.
Who it may be relevant to
Registry conditions: Prediabetes. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Dietary supplement Experimental Product
    Participants will consume two doses per day. The product should be taken 30 minutes before the two main meals of the day.
  • Dietary supplement Control product
    Participants will consume two daily doses of the placebo product. The product should be taken 30 minutes before the two main meals of the day.

Primary outcome measures

  • Glycated Hemoglobin (HbA1c) [Time frame: Measurements will be performed at baseline, Day 45, and Day 90]
  • Area Under the Curve (AUC) of Blood Glucose During Oral Glucose Tolerance Test [Time frame: This assessment will be conducted at baseline, Day 45, and Day 90.]
Secondary outcome measures (6)
  • Fasting and Post-Load Insulinemia [Time frame: These measurements will be performed at baseline, Day 45, and Day 90.]
  • Insulin Resistance [Time frame: They will be calculated at the start of the study, on day 45, and on day 90.]
  • Insulin Sensitivity [Time frame: It will be calculated at the start of the study, on day 45, and on day 90.]
  • Body Composition Analysis [Time frame: These measurements will be performed at baseline, Day 45, and Day 90.]
  • Liver safety variables [Time frame: These measurements will be performed at baseline, on day 45, and on day 90.]
  • Adverse events [Time frame: At 12 weeks after consumption]

Eligibility criteria

Inclusion criteria

  • Subjects of both sexes aged 18-65 years.
  • Diagnosis of glucose intolerance according to the American Diabetes Association (at least one of the following criteria):
  • Impaired fasting glucose (100-125 mg/dl)
  • Impaired glucose tolerance (oral glucose tolerance test with 2-hour plasma glucose between 140-199 mg/dl)
  • Glycated hemoglobin between 5.7% and 6.4%
  • Body mass index between 20-35 kg/m².
  • Stable dietary habits: no weight gain or loss greater than 5 kg in the last ten weeks.
  • Volunteers capable of understanding the clinical study and willing to comply with the study procedures and requirements.

Exclusion criteria

  • Use of medications that may interfere with glucose metabolism.
  • Subjects with a history of any type of hepatic or renal disease.
  • Alcohol consumption greater than 20 g/day.
  • History of allergic hypersensitivity or poor tolerance to any component of the study products.
  • Participation in another clinical trial within the three months prior to the study.
  • Lack of willingness or inability to comply with clinical trial procedures.
  • Pregnant or breastfeeding women.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Prevention

Study locations

Spain · 1 center
  • UCAM HiTech, Sport & Health Innovation Hub — Murcia

Identifiers

NCT: NCT07420998 · UCAMCFE-00041

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗