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Evaluating a Liquid Extract of Carob to Improve Blood Sugar in People With Prediabetes

ConditionPrediabetes (Insulin Resistance, Impaired Glucose Tolerance)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversidad Católica San Antonio de Murcia

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

Subjects of both sexes aged between 18 and 65.

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%

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Carob extract

    Dietary supplement

    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

    Dietary supplement

    Identical characteristics to the product under study. Consumption for 90 days, twice a day.

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: Carob LiquidExperimental treatment 1 intervention
Group B: Control groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
This assessment will be performed at baseline, on day 45, and on day 90.
2

Glycosylated hemoglobin (HbA1c)

Fasting glycosylated hemoglobin (HbA1c) will be measured in venous blood samples to assess long-term glycemic control.

Time frame
Measurements will be taken at baseline, on day 45, and on day 90.

Secondary outcomes

1

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.

Time frame
This assessment will be performed at the start of the study, on day 45, and on day 90.
2

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).

Time frame
Both indices will be calculated at baseline, day 45, and day 90.
3

Body composition analysis

Body composition will be assessed using bioelectrical impedance analysis (BIA), providing estimates of fat mass, lean mass, and total body water.

Time frame
These measurements will be taken at the beginning, on day 45, and on day 90.
4

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)

Time frame
These measurements will be performed at baseline, on day 45, and on day 90.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Universidad Católica San Antonio de Murcia

Lead sponsor

San Antonio Technologies - San Antonio Catholic University of Murcia

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: