- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT05005754
Effect of Probiotics on Cardiometabolic Health
An Interventional Study for the Beneficial Effects of Probiotics on Cardio-metabolic Health in Chinese Subjects
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Guangdong
-
Guangzhou, Guangdong, Kina, 510080
- Sun Yat-sen University
-
Guangzhou, Guangdong, Kina, 510080
- Department of Nutrition and Food Hygiene
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Fyrdubbla
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Probiotics
Subjects are instructed to take one capsule of probiotics daily for a total of 3 months
|
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.
|
|
Placebo-jämförare: Placebo Control
Subjects are instructed to take one capsule of placebo daily for a total of 3 months
|
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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Flow-mediated slowing (FMS)
Tidsram: from baseline to 12 weeks after intervention
|
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.
|
from baseline to 12 weeks after intervention
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
gut microbiota
Tidsram: from baseline to 12 weeks after intervention
|
Alterations of the composition of gut microbiota evaluated by metagenomics
|
from baseline to 12 weeks after intervention
|
|
microbial metabolites
Tidsram: from baseline to 12 weeks after intervention
|
alterations of microbial metabolites evaluated by High performance liquid chromatography-mass spectrometry
|
from baseline to 12 weeks after intervention
|
|
Metabolic Syndrome Severity Z Score (MetZ score)
Tidsram: from baseline to 12 weeks after intervention
|
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.
|
from baseline to 12 weeks after intervention
|
|
Lipid profiles
Tidsram: from baseline to 12 weeks after intervention
|
alterations of blood lipids including total cholesterol, triglyceride, LDL cholesterol and HDL cholesterol determined by automatic biochemical analyser
|
from baseline to 12 weeks after intervention
|
|
Blood pressure
Tidsram: from baseline to 12 weeks after intervention
|
alterations of blood pressure
|
from baseline to 12 weeks after intervention
|
|
Insulin sensitivity
Tidsram: from baseline to 12 weeks after intervention
|
alterations of HOMA-IR index
|
from baseline to 12 weeks after intervention
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- Pro-2021
Plan för individuella deltagardata (IPD)
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