Pre-diabetesNCT07650123
7-Ketolithocholic Acid in Prediabetes
A study testing 7-KLCA and Diet and Physical Activity in people with Pre-diabetes, run by ICE S.p.A. at 8 sites in Italy.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Pre-diabetes
- What is being tested?
- 7-KLCA and Diet and Physical Activity
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 8 sitesItaly
- Study dates
- Jun 2026to Jun 2027
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female participants aged ≥18 years and ≤70 years.
- Ability and willingness to provide written informed consent.
- 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).
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- Body mass index (BMI) in the range 25-31 kg/m2 (inclusive).
- Willingness to strictly comply with a low-glycaemic, hypocaloric diet during the study period and maintain a food diary.
- Willingness to comply with recommended physical activity during the study period and maintain an activity diary.
- 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.
Who cannot join
- Previous or current diagnosis of diabetes mellitus.
- Presence of hypertension, defined as blood pressure >130/85 mmHg.
- Hypertriglyceridemia, defined as fasting blood triglyceride levels ≥ 200 mg/dL.
- LDL cholesterol ≥ 190 mg/dL.
- Current treatment with oral hypoglycaemic agents or use of supplements with hypoglycaemic effects.
- 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).
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- Any medical condition or treatment that, in the opinion of the investigator, could interfere with the study outcomes or participant safety.
- Use of vitamin K antagonist anticoagulant drugs (such as warfarin).
- Pregnancy or breast-feeding.
- 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.
- Subjects with any history of hypersensitivity to the product under study or its excipients (please refer to Appendix B for listing of ingredients).
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
Italy8 sites, 8 recruiting
- Recruiting
Studio Medico, Piazza Eroi della Libertà, 7
Bordighera, 18012
Dr. Germano Mondino, +33 018426921, g.mondino@alice.it
- Recruiting
Studio Medico, Via Roma, 46
Ospedaletti, 18014
Dr. Fabrizia Lanzoni, +33 3923689757, f.lanzoni@outlook.com
- Recruiting
Studio Medico, Via Elba 21
San Bartolomeo al Mare, 18016
Dr. Ettore Perreca, +33 0183409452, ettore.perreca@icloud.com
- Recruiting
Studio Medico, Corso Imperatrice 5
Sanremo, 18038
Dr. Alice Cipolli, +33 3290809722, alice.cipolli.1986@gmail.com
- Recruiting
Studio Medico, Corso Imperatrice 5
Sanremo, 18038
Dr. Leandro Faraldi, +33 3383604828, medicaleo@libero.it
- Recruiting
Studio Medico, Corso Matuzia 13
Sanremo, 18038
Dr. Francesca Viale, +33 366 4947040, dott.vialefrancesca@gmail.com
- Recruiting
Studio Medico, Via Galileo Galilei 475
Sanremo, 18038
Dr. Riccardo Agati, +33 0184636817, riccardo.agati@gmail.com
- Recruiting
Studio Medico, Via Galileo Galilei 475
Sanremo, 18038
Dr. Nicolò Moraglia, +33 3404034229, n.moraglia@gmail.com
About this study
Official title: 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.
- Conditions
- Pre-diabetes
- Being tested
- 7-KLCA, Placebo, Diet and Physical Activity
- Keywords
- 7-KLCA, bile acid, novel food, fasting plasma glucose (FPG), glycated haemoglobin (HbA1c)
- Medical subject headings
- Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
7-KLCADietary supplement
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.
PlaceboDietary supplement
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.
Diet and Physical ActivityOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 7-KLCA | Active comparator | Coated tablets containing 400 mg of 7-Ketolithocholic Acid, taken once daily in tablet form. Receives: Dietary Supplement: 7-KLCA; Other: Diet and Physical Activity |
| Placebo | Placebo comparator | 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. Receives: Dietary Supplement: Placebo; Other: Diet and Physical Activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in Fasting Plasma Glucose (FPG)
Difference in the mean change in fasting plasma glucose (FPG) from baseline to Week 12 between the treatment and placebo groups.
Measured: Baseline and Week 12
Secondary outcomes (1)
Difference in mean changes in HbA1c, cholesterol, LDL, HDL, body weight and/or BMI, waist circumference, 2 hr oral glucose tolerance test.
To observe the effects of 7-Ketolithocholic Acid associated with diet and physical activity on glycaemic metabolism, lipid profile and BMI/waist circumference.
Measured: Baseline and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2026
- Study startJun 2026 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-diabetesStudies 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ICE S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07650123
- Sponsor's protocol ID
- 7Keto-001
- Status last verified
- Jun 2026
- First submitted
- 10 Jun 2026
- Last updated
- 16 Jun 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 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT07650123
- Acronym / sponsor ID
- 7Keto-001
- Conditions
- Pre-diabetes
- Keywords
- 7-KLCA, bile acid, novel food, fasting plasma glucose (FPG), glycated haemoglobin (HbA1c)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- ICE S.p.A.Industry (pharma, biotech, devices)
- Study start
- Jun 2026 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 16 Jun 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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 7-KLCA | Active comparator | Dietary Supplement: 7-KLCA, Other: Diet and Physical ActivityCoated tablets containing 400 mg of 7-Ketolithocholic Acid, taken once daily in tablet form. |
| Placebo | Placebo comparator | Dietary Supplement: Placebo, Other: Diet and Physical ActivityPlacebo 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male and female participants aged ≥18 years and ≤70 years.
- Ability and willingness to provide written informed consent.
- Diagnosis of prediabetes, defined by the following metabolic criteria:
- Body mass index (BMI) in the range 25-31 kg/m2 (inclusive).
- Willingness to strictly comply with a low-glycaemic, hypocaloric diet during the study period and maintain a food diary.
Key exclusion criteria (11 listed)
- Previous or current diagnosis of diabetes mellitus.
- Presence of hypertension, defined as blood pressure >130/85 mmHg.
- Hypertriglyceridemia, defined as fasting blood triglyceride levels ≥ 200 mg/dL.
- LDL cholesterol ≥ 190 mg/dL.
- Current treatment with oral hypoglycaemic agents or use of supplements with hypoglycaemic effects.
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 |
|---|---|---|
| 7-KLCAThis 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. | Dietary supplement | 7-KLCA |
| PlaceboThis 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. | Dietary supplement | Placebo |
| Diet and Physical ActivityThe 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. | Other | 7-KLCA, Placebo |
Primary outcome
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.
1 secondary outcome
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
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 16 Jun 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.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 7-KLCA and Diet and Physical Activity in people with Pre-diabetes, run by ICE S.p.A. at 8 sites in Italy.
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 10 inclusion and 11 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 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Italy. 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 Dr. Riccardo Agati (+33 (0)184636817, riccardo.agati@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change in Fasting Plasma Glucose (FPG) (time frame: Baseline and Week 12). 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 16 Jun 2026.