7-Ketolithocholic Acid in Prediabetes
ConditionPre-diabetes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorICE S.p.A.
About this trial
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.
Eligibility criteria
Qualifiers
Male and female participants aged ≥18 years and ≤70 years.
Ability and willingness to provide written informed consent.
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).
Disqualifiers
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.
Trial design
Treatments tested in this trial
- 7-KLCA
- Placebo
- Diet and Physical Activity
Treatment groups
100 Participants
are divided into 2 treatment groupsLocations
8Studio Medico, Piazza Eroi della Libertà, 718012, Bordighera Italy
Studio Medico, Via Roma, 4618014, Ospedaletti Italy
Studio Medico, Via Elba 2118016, San Bartolomeo al Mare Italy
Studio Medico, Corso Imperatrice 518038, Sanremo Italy
Sponsors and collaborators
ICE S.p.A.
Lead sponsor
Source ClinicalTrials.gov