7-Ketolithocholic Acid in Prediabetes

June 10, 2026 updated by: ICE S.p.A.

A Multicentre, Double Blind, Placebo Controlled, Clinical Trial to Investigate the Effects and Tolerability of 7-Ketolithocholic Acid, a Novel Food, Associated to Diet and Physical Activity, in Lowering Fasting Plasma Glucose (FPG) Levels in Subjects With Pre-diabetes.

7-Ketolithocholic Acid, a naturally occurring bile acid, is a novel food currently under investigation for potential metabolic benefits, including glucose-lowering effects. This study aims to evaluate the efficacy and safety of 7-Ketolithocholic Acid, administered alongside a low-glycaemic, hypocaloric diet, and increased physical activity in reducing fasting plasma glucose and other metabolic parameters in subjects with prediabetes. Demonstrating a clinically meaningful glucose-lowering effect would support its potential role in early intervention to prevent or delay the onset of type 2 diabetes.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Italy
      • Bordighera, Italy, 18012
        • Recruiting
        • Studio Medico, Piazza Eroi della Libertà, 7
        • Contact:
      • Ospedaletti, Italy, 18014
        • Recruiting
        • Studio Medico, Via Roma, 46
        • Contact:
      • San Bartolomeo al Mare, Italy, 18016
        • Recruiting
        • Studio Medico, Via Elba 21
        • Contact:
      • Sanremo, Italy, 18038
        • Recruiting
        • Studio Medico, Corso Imperatrice 5
        • Contact:
      • Sanremo, Italy, 18038
      • Sanremo, Italy, 18038
        • Recruiting
        • Studio Medico, Via Galileo Galilei 475
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Male and female participants aged ≥18 years and ≤70 years.
  2. Ability and willingness to provide written informed consent.

  3. Diagnosis of prediabetes, defined by the following metabolic criteria:

    • Impaired fasting glucose (IFG): fasting plasma glucose levels between 100 and 125 mg/dL.
    • Impaired glucose tolerance (IGT): plasma glucose levels between 140 and 199 mg/dL measured 2 hours after a standard oral glucose tolerance test (OGTT).
    • Elevated HbA1c: HbA1c values between 5.7% and 6.4% (or 42 and 47 mmol/mol).
  4. Body mass index (BMI) in the range 25-31 kg/m2 (inclusive).
  5. Willingness to strictly comply with a low-glycaemic, hypocaloric diet during the study period and maintain a food diary.
  6. Willingness to comply with recommended physical activity during the study period and maintain an activity diary.
  7. Women of childbearing potential must agree to not become pregnant during the study and to use effective contraception (according to Recommendations related to contraception and pregnancy testing in clinical trials.

Exclusion Criteria:

  1. Previous or current diagnosis of diabetes mellitus.
  2. Presence of hypertension, defined as blood pressure >130/85 mmHg.
  3. Hypertriglyceridemia, defined as fasting blood triglyceride levels ≥ 200 mg/dL.
  4. LDL cholesterol ≥ 190 mg/dL.
  5. Current treatment with oral hypoglycaemic agents or use of supplements with hypoglycaemic effects.
  6. Use of any medication (self-medication or prescription medication) or supplementation potentially acting on glucose and lipid parameters within 28 days before entry in the study (or at least 5 times the respective elimination half-life, whichever is longer).
  7. Any medical condition or treatment that, in the opinion of the investigator, could interfere with the study outcomes or participant safety.
  8. Use of vitamin K antagonist anticoagulant drugs (such as warfarin).
  9. Pregnancy or breast-feeding.
  10. Any other condition that would preclude adherence to the study protocol or informed consent process, including, but not limited, to active or uncontrolled metabolic, endocrine, cardiovascular, renal, hepatic, pulmonary, gastrointestinal, neurological, endocrinological, immunological, or psychiatric disease.
  11. Subjects with any history of hypersensitivity to the product under study or its excipients (please refer to Appendix B for listing of ingredients).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: 7-KLCA
Coated tablets containing 400 mg of 7-Ketolithocholic Acid, taken once daily in tablet form.
Dietary supplement: 7-KLCA

This is a prospective, randomized, double blind, multicenter study. Subjects will be randomized in a 1:1 ratio; each subject will be included into one of the two intervention groups.

Each subject will attend 6 visits in total Visit 1: Day -7 (Screening, Informed consent signature, sampling for laboratory tests) Visit 2: Day 0 (Eligibility assessment, enrolment, randomization, drug dispense; diary dispense) Visit 3: Week +4 (Telephone call, diary verification) Visit 4: Week +8 (same as Visit 3) Visit 5: Week +12 (sampling for laboratory tests like Visit 1. Diary verification. End of treatment) Visit 6: Week +16 (End of Study, EOS. Same as visit 5, excluding OGTT) The onset of Adverse Events and the use of Concomitant Medications will be verified and, if necessary, recorded at every visit.

Both groups will undergo a low-glycaemic, hypocaloric diet, and recommended physical activity.

Other: Diet and Physical Activity

The dietary intervention in this study involves a low-glycaemic, hypocaloric diet, aimed at improving glycaemic control, reducing fasting plasma glucose, and supporting weight management, based on official recommendations from authoritative bodies such as the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD).

Physical activity is a cornerstone of lifestyle intervention in prediabetes. It improves insulin sensitivity, glucose metabolism, and cardiovascular risk factors, and facilitates weight management [2,24]. Combining physical activity with dietary modifications enhances prevention of progression to type 2 diabetes. All of the following will be recommended: aerobic exercise, resistance training, reducing sedentary time, flexibility and balance exercises.
Placebo Comparator: Placebo
Placebo tablets with the same aspect and composition of active comparator but not containing any active ingredient (no 7-KLCA), taken once daily in tablet form.
Other: Diet and Physical Activity

The dietary intervention in this study involves a low-glycaemic, hypocaloric diet, aimed at improving glycaemic control, reducing fasting plasma glucose, and supporting weight management, based on official recommendations from authoritative bodies such as the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD).

Physical activity is a cornerstone of lifestyle intervention in prediabetes. It improves insulin sensitivity, glucose metabolism, and cardiovascular risk factors, and facilitates weight management [2,24]. Combining physical activity with dietary modifications enhances prevention of progression to type 2 diabetes. All of the following will be recommended: aerobic exercise, resistance training, reducing sedentary time, flexibility and balance exercises.

Dietary supplement: Placebo

This is a prospective, randomized, double blind, multicenter study. Subjects will be randomized in a 1:1 ratio; each subject will be included into one of the two intervention groups.

Each subject will attend 6 visits in total Visit 1: Day -7 (Screening, Informed consent signature, sampling for laboratory tests) Visit 2: Day 0 (Eligibility assessment, enrolment, randomization, drug dispense; diary dispense) Visit 3: Week +4 (Telephone call, diary verification) Visit 4: Week +8 (same as Visit 3) Visit 5: Week +12 (sampling for laboratory tests like Visit 1. Diary verification. End of treatment) Visit 6: Week +16 (End of Study, EOS. Same as visit 5, excluding OGTT) The onset of Adverse Events and the use of Concomitant Medications will be verified and, if necessary, recorded at every visit.

Both groups will undergo a low-glycaemic, hypocaloric diet, and recommended physical activity.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Mean change in Fasting Plasma Glucose (FPG)
Time Frame: Baseline and Week 12
Difference in the mean change in fasting plasma glucose (FPG) from baseline to Week 12 between the treatment and placebo groups.
Baseline and Week 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Difference in mean changes in HbA1c, cholesterol, LDL, HDL, body weight and/or BMI, waist circumference, 2 hr oral glucose tolerance test.
Time Frame: Baseline and Week 12
To observe the effects of 7-Ketolithocholic Acid associated with diet and physical activity on glycaemic metabolism, lipid profile and BMI/waist circumference.
Baseline and Week 12

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Assessment of overall safety and tolerability of 7-KLCA (400mg) administered for 12 weeks.
Time Frame: Throughout the course of the study period (12 weeks).
Number and description of Adverse Events and Serious Adverse Events (including laboratory changes) in the two groups of treatment (7-Ketolithocholic Acid 400 mg and placebo administered for 12 weeks).
Throughout the course of the study period (12 weeks).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
ICE S.p.A.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 10, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 10, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 16, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 16, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 10, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 7Keto-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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