Evaluating a Liquid Extract of Carob to Improve Blood Sugar in People With Prediabetes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Carob extract, Control product.
- Who it may be relevant to
- Registry conditions: Prediabetes (Insulin Resistance, Impaired Glucose Tolerance). Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Randomized Clinical Trial to Analyze the Efficacy of a Liquid Carob Extract on the Glucose Metabolism of Subjects With Prediabetes.
Overview
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 supplement 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. - Dietary supplement Control product
Identical characteristics to the product under study. Consumption for 90 days, twice a day.
Primary outcome measures
- 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.]
- Glycosylated hemoglobin (HbA1c) [Time frame: Measurements will be taken at baseline, on day 45, and on day 90.]
Secondary outcome measures (5)
- Area under the curve (AUC) of blood insulin during the oral glucose tolerance test [Time frame: This assessment will be performed at the start of the study, on day 45, and on day 90.]
- Insulin resistance and insulin sensitivity indices [Time frame: Both indices will be calculated at baseline, day 45, and day 90.]
- Body composition analysis [Time frame: These measurements will be taken at the beginning, on day 45, and on day 90.]
- Liver safety variables [Time frame: These measurements will be performed at baseline, on day 45, and on day 90.]
- Adverse events [Time frame: At 12 weeks after consumption]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Other
Study locations
Spain · 1 center
- UCAM HiTech, Sport & Health Innovation Hub — Murcia
Identifiers
NCT: NCT07379931 · UCAMCFE-00037