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 groupsSponsors and collaborators
Source ClinicalTrials.gov