7-Ketolithocholic Acid in Prediabetes

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.

Overview

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.

Interventions

• Dietary supplement 7-KLCA
  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)
• Dietary supplement Placebo
  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)
• Other Diet and Physical Activity
  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 cardio

Primary outcome measures

• Mean change in Fasting Plasma Glucose (FPG) [Time frame: Baseline and Week 12]

Secondary outcome measures (1)

• 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]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Prevention

Study locations

Italy · 8 centers

• Studio Medico, Piazza Eroi della Libertà, 7 — Bordighera
• Studio Medico, Via Roma, 46 — Ospedaletti
• Studio Medico, Via Elba 21 — San Bartolomeo al Mare
• Studio Medico, Corso Imperatrice 5 — Sanremo
• Studio Medico, Corso Imperatrice 5 — Sanremo
• Studio Medico, Corso Matuzia 13 — Sanremo
• Studio Medico, Via Galileo Galilei 475 — Sanremo
• Studio Medico, Via Galileo Galilei 475 — Sanremo

Identifiers

NCT: NCT07650123 · 7Keto-001

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗