An interventional study of Experimental Product and Control product in Prediabetes, sponsored by Universidad Católica San Antonio de Murcia. Recruiting at 1 site in Spain. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-19.
Sponsored by Universidad Católica San Antonio de Murcia · Not applicable, Interventional, and Prevention
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.
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.
918 studies on the registry are indexed under Prediabetic State; 232 are open to participants now.
This study's planned enrollment of 30 is below the median of 62 across 762 interventional studies indexed under Prediabetic State.
Browse Prediabetic State studies →Universidad Católica San Antonio de Murcia is the lead sponsor of 138 studies on the registry; 18 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will consume two daily doses of the experimental product (liquid carob extract) for 90 days.
Dietary Supplement: Experimental Product
Participants will consume two daily doses of a placebo product with the same organoleptic characteristics as the experimental product for 90 days.
Dietary Supplement: Control product
Participants will consume two doses per day. The product should be taken 30 minutes before the two main meals of the day.
Also known as: Carob liquid - GippsNature
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.
Also known as: Placebo
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
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.
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.
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.
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.
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.
Liver safety variables
It is a blood test that measures the presence of some enzymes, proteins and bilirubin in the blood, with the aim of determining if there is any alteration in the liver. Enzyme GPT, GOT, Gamma GT, LDH, alkaline phosphatase and bilirubin (UI/L)
Time frame: These measurements will be performed at baseline, on day 45, and on day 90.
Adverse events
It will be evaluated at each of the visits.
Time frame: At 12 weeks after consumption
Plan to share: No
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