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7-Ketolithocholic Acid in Prediabetes

10. Juni 2026 aktualisiert von: 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.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Geschätzt)

100

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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).

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Verhütung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Vervierfachen

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Aktiver Komparator: 7-KLCA
Coated tablets containing 400 mg of 7-Ketolithocholic Acid, taken once daily in tablet form.
Nahrungsergänzungsmittel: 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.

Sonstiges: 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.
Placebo-Komparator: 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.
Sonstiges: 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.

Nahrungsergänzungsmittel: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Mean change in Fasting Plasma Glucose (FPG)
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Difference in mean changes in HbA1c, cholesterol, LDL, HDL, body weight and/or BMI, waist circumference, 2 hr oral glucose tolerance test.
Zeitfenster: 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

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Assessment of overall safety and tolerability of 7-KLCA (400mg) administered for 12 weeks.
Zeitfenster: 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).

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

ICE S.p.A.

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. Juni 2026

Primärer Abschluss (Geschätzt)

1. März 2027

Studienabschluss (Geschätzt)

1. Juni 2027

Studienanmeldedaten

Zuerst eingereicht

10. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

10. Juni 2026

Zuerst gepostet (Tatsächlich)

16. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

16. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

10. Juni 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 7Keto-001

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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