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7-Ketolithocholic Acid in Prediabetes

10 giugno 2026 aggiornato da: ICE S.p.A.

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.

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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

100

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Italia
      • Bordighera, Italia, 18012
        • Reclutamento
        • Studio Medico, Piazza Eroi della Libertà, 7
        • Contatto:
      • Ospedaletti, Italia, 18014
        • Reclutamento
        • Studio Medico, Via Roma, 46
        • Contatto:
      • San Bartolomeo al Mare, Italia, 18016
        • Reclutamento
        • Studio Medico, Via Elba 21
        • Contatto:
      • Sanremo, Italia, 18038
        • Reclutamento
        • Studio Medico, Corso Imperatrice 5
        • Contatto:
      • Sanremo, Italia, 18038
        • Reclutamento
        • Studio Medico, Corso Matuzia 13
        • Contatto:
      • Sanremo, Italia, 18038
        • Reclutamento
        • Studio Medico, Via Galileo Galilei 475
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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).

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: 7-KLCA
Coated tablets containing 400 mg of 7-Ketolithocholic Acid, taken once daily in tablet form.
Integratore alimentare: 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) Visit 5: Week +12 (sampling for laboratory tests like Visit 1. Diary verification. End of treatment) Visit 6: Week +16 (End of Study, EOS. Same as visit 5, excluding OGTT) The onset of Adverse Events and the use of Concomitant Medications will be verified and, if necessary, recorded at every visit.

Both groups will undergo a low-glycaemic, hypocaloric diet, and recommended physical activity.

Altro: 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 cardiovascular risk factors, and facilitates weight management [2,24]. Combining physical activity with dietary modifications enhances prevention of progression to type 2 diabetes. All of the following will be recommended: aerobic exercise, resistance training, reducing sedentary time, flexibility and balance exercises.
Comparatore placebo: Placebo
Placebo tablets with the same aspect and composition of active comparator but not containing any active ingredient (no 7-KLCA), taken once daily in tablet form.
Altro: 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 cardiovascular risk factors, and facilitates weight management [2,24]. Combining physical activity with dietary modifications enhances prevention of progression to type 2 diabetes. All of the following will be recommended: aerobic exercise, resistance training, reducing sedentary time, flexibility and balance exercises.

Integratore alimentare: 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) Visit 5: Week +12 (sampling for laboratory tests like Visit 1. Diary verification. End of treatment) Visit 6: Week +16 (End of Study, EOS. Same as visit 5, excluding OGTT) The onset of Adverse Events and the use of Concomitant Medications will be verified and, if necessary, recorded at every visit.

Both groups will undergo a low-glycaemic, hypocaloric diet, and recommended physical activity.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Mean change in Fasting Plasma Glucose (FPG)
Lasso di tempo: Baseline and Week 12
Difference in the mean change in fasting plasma glucose (FPG) from baseline to Week 12 between the treatment and placebo groups.
Baseline and Week 12

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Difference in mean changes in HbA1c, cholesterol, LDL, HDL, body weight and/or BMI, waist circumference, 2 hr oral glucose tolerance test.
Lasso di tempo: Baseline and Week 12
To observe the effects of 7-Ketolithocholic Acid associated with diet and physical activity on glycaemic metabolism, lipid profile and BMI/waist circumference.
Baseline and Week 12

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Assessment of overall safety and tolerability of 7-KLCA (400mg) administered for 12 weeks.
Lasso di tempo: Throughout the course of the study period (12 weeks).
Number and description of Adverse Events and Serious Adverse Events (including laboratory changes) in the two groups of treatment (7-Ketolithocholic Acid 400 mg and placebo administered for 12 weeks).
Throughout the course of the study period (12 weeks).

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

ICE S.p.A.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 giugno 2026

Completamento primario (Stimato)

1 marzo 2027

Completamento dello studio (Stimato)

1 giugno 2027

Date di iscrizione allo studio

Primo inviato

10 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

10 giugno 2026

Primo Inserito (Effettivo)

16 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

16 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

10 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 7Keto-001

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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Condizioni

Malattie rare

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Sedi

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