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

N/ANot Yet RecruitingNCT07379931

Universidad Católica San Antonio de Murcia70 enrolled

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Enrollment

Conditions

Prediabetes (Insulin Resistance, Impaired Glucose Tolerance)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

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

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.

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.

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.

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.

Adverse events

It will be evaluated at each of the visits.

Time frame: At 12 weeks after consumption