Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07379931

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Prediabetes (Insulin Resistance, Impaired Glucose Tolerance) Diabetes Mellitus Endocrine System Diseases Glucose Intolerance Glucose Metabolism Disorders Hyperglycemia Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases Prediabetic State

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCAM HiTech, Sport & Health Innovation Hub

Murcia, 30107, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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

  1. 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.

    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.

  2. Insulin resistance and insulin sensitivity indices

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

    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).

  3. Body composition analysis

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

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

  4. Liver safety variables

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

    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)

  5. Adverse events

    Time frame: At 12 weeks after consumption

    It will be evaluated at each of the visits.

Sponsors and collaborators

Lead sponsor

Universidad Católica San Antonio de Murcia

Other

Registry information

Official study title

Randomized Clinical Trial to Analyze the Efficacy of a Liquid Carob Extract on the Glucose Metabolism of Subjects With Prediabetes.

Acronym: GLIA

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 2, 2026
Registry last updated
Feb 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.