7-Ketolithocholic Acid in Prediabetes

NCT07650123 | Recruiting

• 1 other identifier: 7Keto-001
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 8

Brief 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 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

Keywords

7-KLCA, bile acid, novel food, fasting plasma glucose (FPG), glycated haemoglobin (HbA1c)

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  Baseline and Week 12

Other Outcomes (1)

• Assessment of overall safety and tolerability of 7-KLCA (400mg) administered for 12 weeks.

  Throughout the course of the study period (12 weeks).

Study Arms (2)

7-KLCA

ACTIVE COMPARATOR

Coated tablets containing 400 mg of 7-Ketolithocholic Acid, taken once daily in tablet form.

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.

Dietary Supplement: Placebo; Other: Diet and Physical Activity

Interventions

7-KLCA DIETARY_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.

7-KLCA

Placebo DIETARY_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.

Placebo

Diet and Physical Activity OTHER

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.

7-KLCA; Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• 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.

You may not qualify if:

• 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).
• 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).

Sponsors & Collaborators

• ICE S.p.A.: lead

Study Sites (8)

Studio Medico, Piazza Eroi della Libertà, 7

Bordighera, 18012, Italy

RECRUITING

Studio Medico, Via Roma, 46

Ospedaletti, 18014, Italy

RECRUITING

Studio Medico, Via Elba 21

San Bartolomeo al Mare, 18016, Italy

RECRUITING

Studio Medico, Corso Imperatrice 5

Sanremo, 18038, Italy

RECRUITING

Studio Medico, Corso Imperatrice 5

Sanremo, 18038, Italy

RECRUITING

Studio Medico, Corso Matuzia 13

Sanremo, 18038, Italy

RECRUITING

Studio Medico, Via Galileo Galilei 475

Sanremo, 18038, Italy

RECRUITING

Studio Medico, Via Galileo Galilei 475

Sanremo, 18038, Italy

RECRUITING

MeSH Terms

Conditions

Glucose Intolerance

Interventions

Diet; Exercise

Condition Hierarchy (Ancestors)

Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Dr. Riccardo Agati

CONTACT

+33 (0)184636817; riccardo.agati@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2026
• First Posted: June 16, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: June 16, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (8)