- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT05005754
Effect of Probiotics on Cardiometabolic Health
An Interventional Study for the Beneficial Effects of Probiotics on Cardio-metabolic Health in Chinese Subjects
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Atherosclerosis is a major risk factor for cardiovascular diseases. Recently, dysbiosis of gut microbiota has been reported to play an important role in the pathogenesis of atherosclerosis. Animal studies have demonstrated that administration of probiotics help delay the progression of atherosclerosis through several mechanisms such as reduction in endotoxemia, and enhanced production of short-chain fatty acids.
However, whether administration of probiotics also has a protective effect in subjects with metabolic syndrome (MetS), who are at high risk for developing atherosclerosis, remain unknown.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Guangdong
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Guangzhou, Guangdong, Cina, 510080
- Sun Yat-sen University
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Guangzhou, Guangdong, Cina, 510080
- Department of Nutrition and Food Hygiene
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Local residents aged between 30-60 years old;
- Stable weight (<5% weight change over last 3 months);
- Central obesity defined as waist circumference ≥90 cm in males or ≥80 cm in females, Plus any two of the following four conditions i) Elevated triglycerides: serum triglycerides ≥150 mg/dL (1.7 mmol/L); ii) Reduced HDL cholesterol: serum HDL-c <40 mg/dL (1.03 mmol/L) in males or <50 mg/dL (1.29 mmol/L) in females; iii) Elevated blood pressure: systolic blood pressure ≥130 mmHg or diastolic blood pressure ≥85 mmHg; iv) Elevated fasting plasma glucose: fasting plasma glucose ≥100 mg/dL (5.6 mmol/L)
- Absence of any systemic, cardiovascular diseases, as well as infections within the previous month;
- Absence of any diet or medication that might interfere with metabolic homoeostasis and gut microbiota, especially antibiotics and probiotics 4 weeks before recruitment.
Exclusion Criteria:
- Acute illness or current evidence of acute or chronic inflammatory of infective diseases;
- Participation in regular diet program more than 2 times per week in the latest 3 months prior to recruitment;
- Mental illness rendering them unable to understand the nature, scope, and possible consequences of the study.
Piano di studio
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 |
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Sperimentale: Probiotics
Subjects are instructed to take one capsule of probiotics daily for a total of 3 months
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During the study period, subjects are instructed to take one capsule of probiotics daily for a total of 3 months.
Aside from the probiotic supplement, all participants are instructed to continue their normal routine and not make any changes to their habitual diet or exercise habits.
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Comparatore placebo: Placebo Control
Subjects are instructed to take one capsule of placebo daily for a total of 3 months
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During the study period, subjects are instructed to take one capsule of placebo control daily for a total of 3 months.
Aside from the probiotic supplement, all participants are instructed to continue their normal routine and not make any changes to their habitual diet or exercise habits.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Flow-mediated slowing (FMS)
Lasso di tempo: from baseline to 12 weeks after intervention
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FMS is a simple test for endothelial functions measured by Vicorder.
In patients whose endothelial function or flow-mediated vasodilation are compromised, the FMS is substantially reduced.
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from baseline to 12 weeks after intervention
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
gut microbiota
Lasso di tempo: from baseline to 12 weeks after intervention
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Alterations of the composition of gut microbiota evaluated by metagenomics
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from baseline to 12 weeks after intervention
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microbial metabolites
Lasso di tempo: from baseline to 12 weeks after intervention
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alterations of microbial metabolites evaluated by High performance liquid chromatography-mass spectrometry
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from baseline to 12 weeks after intervention
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Metabolic Syndrome Severity Z Score (MetZ score)
Lasso di tempo: from baseline to 12 weeks after intervention
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MetZ score is an weighted score of the five traditional components of Metabolic syndrome (waist, triglyceride, HDL cholesterol, SBP and fasting glucose).
It's used to evaluate the severity of metabolic disorder, and a higher score indicates a more severe status.
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from baseline to 12 weeks after intervention
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Lipid profiles
Lasso di tempo: from baseline to 12 weeks after intervention
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alterations of blood lipids including total cholesterol, triglyceride, LDL cholesterol and HDL cholesterol determined by automatic biochemical analyser
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from baseline to 12 weeks after intervention
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Blood pressure
Lasso di tempo: from baseline to 12 weeks after intervention
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alterations of blood pressure
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from baseline to 12 weeks after intervention
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Insulin sensitivity
Lasso di tempo: from baseline to 12 weeks after intervention
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alterations of HOMA-IR index
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from baseline to 12 weeks after intervention
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Collaboratori e investigatori
Sponsor
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- Pro-2021
Piano per i dati dei singoli partecipanti (IPD)
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Informazioni su farmaci e dispositivi, documenti di studio
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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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