Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Carob Liquid | Experimental | Nutritional product: liquid carob extract. |
|
| Control group | Placebo Comparator | Nutritional product: placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carob extract | Dietary Supplement | Consumo durante 90 dÃas. La dosis diaria del producto es de 6,66 g/dÃa, dividida en dos dosis de 3,33 g/dosis al dÃa. El producto debe tomarse 30 minutos antes de las dos comidas principales del dÃa. |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the curve (AUC) of blood glucose during the oral glucose tolerance test | 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. | This assessment will be performed at baseline, on day 45, and on day 90. |
| Glycosylated hemoglobin (HbA1c) | Fasting glycosylated hemoglobin (HbA1c) will be measured in venous blood samples to assess long-term glycemic control. | Measurements will be taken at baseline, on day 45, and on day 90. |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the curve (AUC) of blood insulin during the oral glucose tolerance test | 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. | This assessment will be performed at the start of the study, on day 45, and on day 90. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Fco Javier López Roman, Medical degree | Catholic University of Murcia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCAM HiTech, Sport & Health Innovation Hub | Murcia | Murcia | 30107 | Spain |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D011236 | Prediabetic State |
| D007333 | Insulin Resistance |
| D018149 | Glucose Intolerance |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C017471 | locust bean gum |
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Control product | Dietary Supplement | Identical characteristics to the product under study. Consumption for 90 days, twice a day. |
|
| Insulin resistance and insulin sensitivity indices | 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). | Both indices will be calculated at baseline, day 45, and 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. | These measurements will be taken at the beginning, on day 45, and on 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) | 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. | At 12 weeks after consumption |
| D004700 | Endocrine System Diseases |
| D006946 | Hyperinsulinism |
| D006943 | Hyperglycemia |
| D008722 | Methods |