Randomized Clinical Trial to Analyze the Efficacy of a Liquid Carob Extract on the Glucose Metabolism of Subjects With Prediabetes.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- Area under the curve (AUC) of blood glucose during the oral glucose tolerance test
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Subjects of both sexes aged between 18 and
- •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/m
- •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.
Arms & Interventions
Carob Liquid
Nutritional product: liquid carob extract.
Intervention: Carob extract (Dietary Supplement)
Control group
Nutritional product: placebo
Intervention: Control product (Dietary Supplement)
Outcomes
Primary Outcomes
Area under the curve (AUC) of blood glucose during the oral glucose tolerance test
Time Frame: 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)
Time Frame: 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 Outcomes
- 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.)
- Insulin resistance and insulin sensitivity indices(Both indices will be calculated at baseline, day 45, and day 90.)
- Body composition analysis(These measurements will be taken at the beginning, on day 45, and on day 90.)
- Liver safety variables(These measurements will be performed at baseline, on day 45, and on day 90.)
- Adverse events(At 12 weeks after consumption)
Investigators
Francisco Javier López Román
Medical degree
San Antonio Technologies - San Antonio Catholic University of Murcia