Prediabetes
Conditions
Keywords
Glucose, Insulin, Carob, Prediabetes
Brief 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.
Interventions
DIETARY_SUPPLEMENTExperimental Product
Participants will consume two doses per day. The product should be taken 30 minutes before the two main meals of the day.
DIETARY_SUPPLEMENTControl 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.
Sponsors
Universidad Católica San Antonio de Murcia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)
Masking description
Double-blind study. The organoleptic characteristics of the experimental product and the placebo will be identical.
Intervention model description
Controlled, randomized, double-blind clinical trial with two parallel study arms based on the product consumed (placebo or nutritional product containing carob extract) and conducted at a single center.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glycated Hemoglobin (HbA1c) | Measurements will be performed at baseline, Day 45, and Day 90 | Fasting glycated hemoglobin (HbA1c) will be measured in venous blood samples to assess long-term glycemic control. |
| Area Under the Curve (AUC) of Blood Glucose During Oral Glucose Tolerance Test | This assessment will be conducted at baseline, Day 45, and Day 90. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fasting and Post-Load Insulinemia | These measurements will be performed at baseline, Day 45, and Day 90. | 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). |
| Insulin Resistance | They will be calculated at the start of the study, on day 45, and on day 90. | 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) |
| Insulin Sensitivity | It will be calculated at the start of the study, on day 45, and on day 90. | Insulin sensitivity will be assessed using validated surrogate indices derived from fasting glucose and insulin levels: QUICKI (Quantitative Insulin Sensitivity Check Index). |
| Body Composition Analysis | These measurements will be performed at baseline, Day 45, and Day 90. | Body composition will be assessed using bioelectrical impedance analysis (BIA), providing estimates of fat mass, lean mass, and total body water. |
| Liver safety variables | These measurements will be performed at baseline, on day 45, and on day 90. | 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) |
| Adverse events | At 12 weeks after consumption | It will be evaluated at each of the visits. |
Countries
Spain
Contacts
CONTACTFrancisco Javier López Román
Outcome results
None listed