Prediabetes (Insulin Resistance, Impaired Glucose Tolerance)GLIANCT07379931
Evaluating a Liquid Extract of Carob to Improve Blood Sugar in People With Prediabetes
A study testing Carob extract in people with Prediabetes (Insulin Resistance, Impaired Glucose Tolerance), run by Universidad Católica San Antonio de Murcia at 1 site in Spain.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Prediabetes (Insulin Resistance, Impaired Glucose Tolerance)
- What is being tested?
- Carob extract
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2026to 30 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Randomized Clinical Trial to Analyze the Efficacy of a Liquid Carob Extract on the Glucose Metabolism of Subjects 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.
Read the 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.
- Being tested
- Carob extract, Control product
- Keywords
- Prediabetes, Glucose, Carob, Placebo
- Medical subject headings
- Prediabetic State, Insulin Resistance, Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carob extractDietary 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 productDietary supplement
Identical characteristics to the product under study. Consumption for 90 days, twice a day.
| Study group | Role | What they receive |
|---|---|---|
| Carob Liquid | Experimental | Nutritional product: liquid carob extract. Receives: Dietary Supplement: Carob extract |
| Control group | Placebo comparator | Nutritional product: placebo Receives: Dietary Supplement: Control product |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Measurements will be taken at baseline, on day 45, and on day 90.
Secondary outcomes (5)
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.
Measured: 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).
Measured: 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.
Measured: 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)
Measured: 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.
Measured: At 12 weeks after consumption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2026
- Study start1 Jan 2026 (estimated)
- Primary completion15 Apr 2026 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prediabetes (Insulin Resistance, Impaired Glucose Tolerance)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Católica San Antonio de Murcia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francisco Javier López Román, San Antonio Technologies - San Antonio Catholic University of Murcia
- Investigators
- Fco Javier López Roman, Medical degree, Principal investigator, Catholic University of Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07379931
- Sponsor's protocol ID
- UCAMCFE-00037
- Acronym
- GLIA
- Status last verified
- Jan 2026
- First submitted
- 17 Dec 2025
- Last updated
- 2 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial to Analyze the Efficacy of a Liquid Carob Extract on the Glucose Metabolism of Subjects With Prediabetes.
- ClinicalTrials.gov ID
- NCT07379931
- Acronym / sponsor ID
- GLIA / UCAMCFE-00037
- Keywords
- Prediabetes, Glucose, Carob, Placebo
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Universidad Católica San Antonio de MurciaUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 15 Apr 2026 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 2 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Carob Liquid | Experimental | Dietary Supplement: Carob extractNutritional product: liquid carob extract. |
| Control group | Placebo comparator | Dietary Supplement: Control productNutritional product: placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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%
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Carob extractConsumo 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 | Carob Liquid |
| Control productIdentical characteristics to the product under study. Consumption for 90 days, twice a day. | Dietary supplement | Control group |
Primary outcome
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.
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fco Javier López Roman, Medical degree principal investigator
Catholic University of Murcia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carob extract in people with Prediabetes (Insulin Resistance, Impaired Glucose Tolerance), run by Universidad Católica San Antonio de Murcia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2026.