PrediabetesNUTIFOODNCT07420998
Effect of a Nutritional Product Containing Carob Extract on Carbohydrate Metabolism in Glucose-intolerant Subjects
A study testing Experimental Product in people with Prediabetes, run by Universidad Católica San Antonio de Murcia at 1 site in Spain.
Trial summary
Randomized, controlled, double-blind clinical trial with two parallel arms based on the product consumed (experimental product and placebo product) and conducted at a single center, to measure the efficacy of the liquid NUTIFOOD product (nutritional product with carob extract) on carbohydrate metabolism. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Prediabetes
- What is being tested?
- Experimental Product
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 26 Jan 2026to Jul 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 18-65 years.
- Diagnosis of glucose intolerance according to the American Diabetes Association (at least one of the following criteria):
- Impaired fasting glucose (100-125 mg/dl)
- Impaired glucose tolerance (oral glucose tolerance test with 2-hour plasma glucose between 140-199 mg/dl)
- Glycated hemoglobin between 5.7% and 6.4%
- Body mass index between 20-35 kg/m².
- Stable dietary habits: no weight gain or loss greater 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 hepatic or renal disease.
- Alcohol consumption greater than 20 g/day.
- History of allergic hypersensitivity or poor tolerance to any component of the study products.
- Participation in another clinical trial within the three months prior to the study.
- Lack of willingness 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.
Spain1 site, 1 recruiting
- Recruiting
UCAM HiTech, Sport & Health Innovation Hub
Murcia
Francisco Javier López Román, 968278157 ext. 157, jlroman@ucam.edu
About this study
Official title: Randomized Clinical Trial on the Effect of a Nutritional Product Containing Carob Extract (NUTIFOOD) on Carbohydrate Metabolism in Glucose-intolerant Subjects
Randomized, controlled, double-blind clinical trial with two parallel arms based on the product consumed (experimental product and placebo product) and conducted at a single center, to measure the efficacy of the liquid NUTIFOOD product (nutritional product with carob extract) on carbohydrate metabolism.
Read the detailed description
This study evaluates the effects of NUTIFOOD (liquid nutritional product with carob extract) on insulin sensitivity and carbohydrate metabolism in subjects with abnormal glucose or HbA1c levels not on antidiabetic medication, over 90 days.
Key assessments include: Glucose response (AUC and peak levels) during an oral glucose tolerance test. Changes in fasting glucose, HbA1c, and basal insulin. Insulin resistance measured by HOMA-IR and QUICKI. Effects on body composition. Safety and tolerability of the product.
The study aims to determine the potential of NUTIFOOD as a nutritional intervention to improve glucose regulation and metabolic health.
- Conditions
- Prediabetes
- Being tested
- Experimental Product, Control product
- Keywords
- Glucose, Insulin, Carob, Prediabetes
- Medical subject headings
- Prediabetic State, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental ProductDietary supplement
Also called Carob liquid - GippsNature
Participants will consume two doses per day. The product should be taken 30 minutes before the two main meals of the day.
Control productDietary supplement
Also called Placebo
Participants will consume two daily doses of the placebo product. The product should be taken 30 minutes before the two main meals of the day.
| Study group | Role | What they receive |
|---|---|---|
| Carob liquid - GippsNature | Experimental | Participants will consume two daily doses of the experimental product (liquid carob extract) for 90 days. Receives: Dietary Supplement: Experimental Product |
| Placebo | Placebo comparator | Participants will consume two daily doses of a placebo product with the same organoleptic characteristics as the experimental product for 90 days. Receives: Dietary Supplement: Control product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycated Hemoglobin (HbA1c)
Fasting glycated hemoglobin (HbA1c) will be measured in venous blood samples to assess long-term glycemic control.
Measured: Measurements will be performed at baseline, Day 45, and Day 90
Area Under the Curve (AUC) of Blood Glucose During Oral Glucose Tolerance Test
The area under the curve (AUC) of blood glucose will be calculated during an oral glucose tolerance test (OGTT) using a 50-g glucose load. 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 conducted at baseline, Day 45, and Day 90.
Secondary outcomes (6)
Fasting and Post-Load Insulinemia
Fasting venous insulin levels will be measured at baseline. Post-load venous insulin concentrations will be determined at 45 and 90 minutes during the oral glucose tolerance test (50-g glucose load).
Measured: These measurements will be performed at baseline, Day 45, and Day 90.
Insulin Resistance
Peripheral insulin resistance will be assessed using validated surrogate indices derived from fasting glucose and insulin levels: HOMA-IR (Homeostatic Model Assessment of Insulin Resistance)
Measured: They will be calculated at the start of the study, on day 45, and on day 90.
Insulin Sensitivity
Insulin sensitivity will be assessed using validated surrogate indices derived from fasting glucose and insulin levels: QUICKI (Quantitative Insulin Sensitivity Check Index).
Measured: It will be calculated at the start of the study, on day 45, and on 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 performed at baseline, Day 45, and 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 posted19 Feb 2026
- Study start26 Jan 2026
- Primary completionApr 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrediabetesStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Controlled, randomized, double-blind clinical trial with two parallel study arms based on the product consumed (placebo or nutritional product containing carob extract) and conducted at a single center.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 30 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, Universidad Católica San Antonio de Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07420998
- Sponsor's protocol ID
- UCAMCFE-00041
- Acronym
- NUTIFOOD
- Status last verified
- Feb 2026
- First submitted
- 16 Dec 2025
- Last updated
- 19 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial on the Effect of a Nutritional Product Containing Carob Extract (NUTIFOOD) on Carbohydrate Metabolism in Glucose-intolerant Subjects
- ClinicalTrials.gov ID
- NCT07420998
- Acronym / sponsor ID
- NUTIFOOD / UCAMCFE-00041
- Conditions
- Prediabetes
- Keywords
- Glucose, Insulin, Carob, Prediabetes
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Universidad Católica San Antonio de MurciaUniversity, hospital or other
- Study start
- 26 Jan 2026 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 19 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.
Randomized, controlled, double-blind clinical trial with two parallel arms based on the product consumed (experimental product and placebo product) and conducted at a single center, to measure the efficacy of the liquid NUTIFOOD product (nutritional product with carob extract) on carbohydrate metabolism.
Detailed description
This study evaluates the effects of NUTIFOOD (liquid nutritional product with carob extract) on insulin sensitivity and carbohydrate metabolism in subjects with abnormal glucose or HbA1c levels not on antidiabetic medication, over 90 days.
Key assessments include: Glucose response (AUC and peak levels) during an oral glucose tolerance test. Changes in fasting glucose, HbA1c, and basal insulin. Insulin resistance measured by HOMA-IR and QUICKI. Effects on body composition. Safety and tolerability of the product.
The study aims to determine the potential of NUTIFOOD as a nutritional intervention to improve glucose regulation and metabolic health.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Controlled, randomized, double-blind clinical trial with two parallel study arms based on the product consumed (placebo or nutritional product containing carob extract) and conducted at a single center.
| Arm | Type | Receives |
|---|---|---|
| Carob liquid - GippsNature | Experimental | Dietary Supplement: Experimental ProductParticipants will consume two daily doses of the experimental product (liquid carob extract) for 90 days. |
| Placebo | Placebo comparator | Dietary Supplement: Control productParticipants will consume two daily doses of a placebo product with the same organoleptic characteristics as the experimental product for 90 days. |
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 18-65 years.
- Diagnosis of glucose intolerance according to the American Diabetes Association (at least one of the following criteria):
- Impaired fasting glucose (100-125 mg/dl)
- Impaired glucose tolerance (oral glucose tolerance test with 2-hour plasma glucose between 140-199 mg/dl)
- 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 hepatic or renal disease.
- Alcohol consumption greater than 20 g/day.
- History of allergic hypersensitivity or poor tolerance to any component of the study products.
- Participation in another clinical trial within 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 |
|---|---|---|
| Experimental ProductAlso: Carob liquid - GippsNatureParticipants will consume two doses per day. The product should be taken 30 minutes before the two main meals of the day. | Dietary supplement | Carob liquid - GippsNature |
| Control productAlso: PlaceboParticipants will consume two daily doses of the placebo product. The product should be taken 30 minutes before the two main meals of the day. | Dietary supplement | Placebo |
Primary outcome
Glycated Hemoglobin (HbA1c)
Time frame: Measurements will be performed at baseline, Day 45, and Day 90
Fasting glycated hemoglobin (HbA1c) will be measured in venous blood samples to assess long-term glycemic control.
Area Under the Curve (AUC) of Blood Glucose During Oral Glucose Tolerance Test
Time frame: This assessment will be conducted at baseline, Day 45, and Day 90.
The area under the curve (AUC) of blood glucose will be calculated during an oral glucose tolerance test (OGTT) using a 50-g glucose load. Capillary blood glucose levels will be measured at 0, 15, 30, 45, 60, 90, and 120 minutes after glucose ingestion.
6 secondary outcomes
Fasting and Post-Load Insulinemia
Time frame: These measurements will be performed at baseline, Day 45, and Day 90.
Insulin Resistance
Time frame: They will be calculated at the start of the study, on day 45, and on day 90.
Insulin Sensitivity
Time frame: It will be calculated at the start of the study, on day 45, and on day 90.
Body Composition Analysis
Time frame: These measurements will be performed at baseline, Day 45, and 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 19 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental Product in people with Prediabetes, 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: looking for participants now, as of the sponsor's last update on 19 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?
Contact Francisco Javier López Román (968278157 ext. 157, jlroman@ucam.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycated Hemoglobin (HbA1c) (time frame: Measurements will be performed at baseline, Day 45, and 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 19 Feb 2026.