Prediabetes (Insulin Resistance, Impaired Glucose Tolerance)
Conditions
Keywords
Prediabetes, Glucose, Carob, Placebo
Brief summary
This study evaluates whether a liquid carob extract can improve blood glucose levels in individuals with prediabetes. Participants are selected according to predefined health criteria and randomly assigned to two groups: one group receives the carob extract and the other receives an inert liquid (placebo). Blood samples are collected and glucose-related parameters are measured throughout the study to assess changes over time. The objective is to determine whether this extract may contribute to better glycemic control and help prevent progression to diabetes.
Detailed description
This study is designed to assess the efficacy of a carob extract on glucose metabolism in individuals presenting impaired fasting glucose or elevated glycated hemoglobin levels, without current antidiabetic pharmacological treatment. Participants will consume the extract for 90 days, and metabolic outcomes will be compared with baseline values. Secondary objectives include assessing changes in glucose area under the curve and peak glucose levels following an oral glucose tolerance test; evaluating variations in fasting glucose and fasting insulin levels after 90 days of intake; and determining changes in peripheral insulin resistance using the HOMA-IR and QUICKI indices. Additionally, potential effects on body composition will be assessed in individuals with abnormal fasting glucose or HbA1c values. Product safety will be monitored and analyzed throughout the study period.
Interventions
DIETARY_SUPPLEMENTCarob extract
Consumo durante 90 días. La dosis diaria del producto es de 6,66 g/día, dividida en dos dosis de 3,33 g/dosis al día. El producto debe tomarse 30 minutos antes de las dos comidas principales del día.
DIETARY_SUPPLEMENTControl product
Identical characteristics to the product under study. Consumption for 90 days, twice a day.
Sponsors
Universidad Católica San Antonio de Murcia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Subjects of both sexes aged between 18 and 65. * Diagnosis of prediabetes according to the American Diabetes Association (at least one of the following criteria): * Impaired fasting glucose (100-125 mg/dL) * Glucose intolerance (oral glucose tolerance test with blood glucose between 140-199 mg/dL after 2 hours). * Glycated hemoglobin between 5.7 and 6.4% * Subjects with a body mass index between 20-35 kg/m2. * Stable eating habits: no weight gain or loss of more 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 liver or kidney disease. * Alcohol consumption greater than 20 g/day. * History of allergic hypersensitivity or poor tolerance to any component of the products under study. * Participation in another clinical trial in the three months prior to the study. * Unwillingness or inability to comply with clinical trial procedures. * Pregnant or breastfeeding women.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area under the curve (AUC) of blood glucose during the oral glucose tolerance test | This assessment will be performed at baseline, on day 45, and on day 90. | The area under the curve (AUC) of blood glucose during an oral glucose tolerance test (OGTT) with a glucose load of 50 g will be calculated. Capillary blood glucose levels will be measured at 0, 15, 30, 45, 60, 90, and 120 minutes after glucose ingestion. |
| Glycosylated hemoglobin (HbA1c) | Measurements will be taken at baseline, on day 45, and on day 90. | Fasting glycosylated hemoglobin (HbA1c) will be measured in venous blood samples to assess long-term glycemic control. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area under the curve (AUC) of blood insulin during the oral glucose tolerance test | This assessment will be performed at the start of the study, on day 45, and on day 90. | The area under the curve (AUC) of insulinemia will be calculated during an oral glucose tolerance test (OGTT) with a glucose load of 50 g. Serum insulin levels will be measured at 0, 15, 30, 45, 60, 90, and 120 minutes after glucose ingestion. |
| Insulin resistance and insulin sensitivity indices | Both indices will be calculated at baseline, day 45, and day 90. | Peripheral insulin resistance and insulin sensitivity will be assessed using validated surrogate indices derived from fasting glucose and insulin levels: HOMA-IR (Homeostasis Model Assessment of Insulin Resistance) QUICKI (Quantitative Insulin Sensitivity Quotient). |
| Body composition analysis | These measurements will be taken at the beginning, on day 45, and on 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
PRINCIPAL_INVESTIGATORFco Javier López Roman, Medical degree
Catholic University of Murcia
Outcome results
None listed