7-Ketolithocholic Acid in Prediabetes

ClinicalTrials.gov ID

NCT07650123

Lead Sponsor

ICE S.p.A.INDUSTRY

Overall Status

Recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

100Estimated

Last Update Posted

Jun 16, 2026Actual

Start Date

Jun 2026Estimated

Primary Completion Date

Mar 2027Estimated

Completion Date

Jun 2027Estimated

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.

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.

• Pre-diabetes

• 7-KLCA
• Placebo
• Diet and Physical Activity

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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).

Primary Purpose

Prevention

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Quadruple

Lead Sponsor

ICE S.p.A.INDUSTRY

f.lanzoni@outlook.com+33 3923689757

ettore.perreca@icloud.com+33 0183409452

alice.cipolli.1986@gmail.com+33 3290809722

medicaleo@libero.it+33 3383604828

dott.vialefrancesca@gmail.com+33 366 4947040

riccardo.agati@gmail.com+33 0184636817

n.moraglia@gmail.com+33 3404034229

• Study to Assess the Effects of Non Digestible Carbohydrates on Long-Term Glucose Homeostasis in Untreated Prediabetic Subjects

  NCT04767672

  Unknown statusInterventionalNot ApplicableUpdated Jan 3, 2024
• The Effects of Dietary Supplements on Glycemic Control, Body Composition and Hepatic Fat Content in People With Prediabetes

  NCT06437938

  Unknown statusInterventionalNot ApplicableUpdated May 31, 2024
• Examining the Effect of Exogenous Ketone Supplementation on Glucose Control in Type 2 Diabetes

  NCT05155410

  CompletedInterventionalNot ApplicableUpdated Apr 13, 2023
• Dietary Interventions in Prediabetes

  NCT01729078

  CompletedInterventionalNot ApplicableUpdated Jul 29, 2015
• Clinical Trial to Evaluate the Efficacy and Safety of the Probiotic Strains Limosilactocillus Reuteri DSM 32910 and Lacticaseibacillus Paracasei DSM 32851 on Glucose Homeostatis in Prediabetic Adults

  NCT04767789

  CompletedInterventionalNot ApplicableUpdated Jun 15, 2023
• Trial of an Herb and Mineral Combination Product on Fasting Glucose in Adults at Risk for Developing Diabetes

  NCT02146157

  CompletedInterventionalNot ApplicableUpdated Oct 14, 2015