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

ConditionPrediabetes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversidad Católica San Antonio de Murcia

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Subjects of both sexes aged 18-65 years.

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%

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Experimental Product

    Dietary supplement

    Participants will consume two doses per day. The product should be taken 30 minutes before the two main meals of the day.

  • Control product

    Dietary supplement

    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.

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Carob liquid - GippsNatureExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Glycated Hemoglobin (HbA1c)

Fasting glycated hemoglobin (HbA1c) will be measured in venous blood samples to assess long-term glycemic control.

Time frame
Measurements will be performed at baseline, Day 45, and Day 90
2

Area Under the Curve (AUC) of Blood Glucose During Oral Glucose Tolerance Test

The area under the curve (AUC) of blood glucose will be calculated during an oral glucose tolerance test (OGTT) using a 50-g glucose load. Capillary blood glucose levels will be measured at 0, 15, 30, 45, 60, 90, and 120 minutes after glucose ingestion.

Time frame
This assessment will be conducted at baseline, Day 45, and Day 90.

Secondary outcomes

1

Fasting and Post-Load Insulinemia

Fasting venous insulin levels will be measured at baseline. Post-load venous insulin concentrations will be determined at 45 and 90 minutes during the oral glucose tolerance test (50-g glucose load).

Time frame
These measurements will be performed at baseline, Day 45, and Day 90.
2

Insulin Resistance

Peripheral insulin resistance will be assessed using validated surrogate indices derived from fasting glucose and insulin levels: HOMA-IR (Homeostatic Model Assessment of Insulin Resistance)

Time frame
They will be calculated at the start of the study, on day 45, and on day 90.
3

Insulin Sensitivity

Insulin sensitivity will be assessed using validated surrogate indices derived from fasting glucose and insulin levels: QUICKI (Quantitative Insulin Sensitivity Check Index).

Time frame
It will be calculated at the start of the study, on day 45, and on day 90.
4

Body Composition Analysis

Body composition will be assessed using bioelectrical impedance analysis (BIA), providing estimates of fat mass, lean mass, and total body water.

Time frame
These measurements will be performed at baseline, Day 45, and Day 90.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Universidad Católica San Antonio de Murcia

Lead sponsor

Source ClinicalTrials.gov
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