7-Ketolithocholic Acid in Prediabetes (NCT07650123) | Clinical Trial Compass
RecruitingNot Applicable
7-Ketolithocholic Acid in Prediabetes
Italy100 participantsStarted 2026-06
Plain-language 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.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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:
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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).