The impact of PRobiotics On Metabolic status And GENeral well-being in an overweight population (PROMAGEN)

Cultech Ltd0 个研究点目标入组 220 人开始时间: 2019年3月12日最近更新: 2023年5月29日

适应症

试验速览

2020 Results article in https://doi.org/10.1038/s41598-020-60991-7 results (added 05/06/2020) 2021 Results article in https://doi.org/10.1080/19490976.2021.1900997 Further analysis (added 19/05/2023)

•1. Aged between 30 and 65 years at stage 1
•2. Waist circumference >89 cm (women) or >100 cm (men) at stage 1
•3. Body mass index (BMI) between 25 and 34.9 kg/m2 at stage 1
•4. Willing to provide blood samples at stage 1 and stage 3
•5. No statin treatment or on stabilised statin therapy (at least 3 months intake before stage 1)

•1. Immunodeficiency or ongoing immunosuppressive therapy
•2. Diagnosed diabetes
•3. Pregnant or planning pregnancy
•4. Anamnesis of ischemic heart disease, heart failure, prolonged QTc interval, rhythm and conduction disorders, e.g. absolute arrhythmia, ventricular extrasystole, atrioventricular block or any other cardiovascular disease deemed by the investigator as a risk for the participation in the study
•5. Severe systemic disease (cancer, dementia, advanced organ failure)
•6. Weight loss in the last 3 months prior to stage 1, which cannot be explained with a dietary regimen or increased physical activity

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