Carob 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.
Control product: Identical characteristics to the product under study. Consumption for 90 days, twice a day.
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
Accepted
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.
Primary outcome measure(s)
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.
Trial sites (1)
Facility
City
Region
Status
UCAM HiTech, Sport & Health Innovation Hub
Murcia
Murcia
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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