Red Wine Effects Upon Gut Flora and Plasma Levels of Trimethylamine-N-oxide (TMAO) - WineFlora Study
Ключови думи
Резюме
Дати
Последна проверка: | 04/30/2017 |
Първо изпратено: | 06/19/2017 |
Очаквано записване подадено: | 07/25/2017 |
Първо публикувано: | 07/26/2017 |
Изпратена последна актуализация: | 07/25/2017 |
Последна актуализация публикувана: | 07/26/2017 |
Действителна начална дата на проучването: | 08/30/2016 |
Приблизителна дата на първично завършване: | 10/31/2017 |
Очаквана дата на завършване на проучването: | 11/30/2017 |
Състояние или заболяване
Интервенция / лечение
Dietary Supplement: Red Wine group (RW)
Other: Abstemious
Фаза
Групи за ръце
Arm | Интервенция / лечение |
---|---|
Experimental: Red Wine group (RW) After a two weeks washout period,in the intervening period with red wine, patients will receive 250 mL / day of red wine per Day, 5 days a week, for 3 weeks. | Dietary Supplement: Red Wine group (RW) After a two weeks washout period,in the intervening period with red wine, patients will receive 250 mL / day of red wine per Day, 5 days a week, for 3 weeks. |
Active Comparator: Abstemious After a two weeks washout period,in the Abstemious period, patients should not consume any kind of alcohol beverages, for 3 weeks | Other: Abstemious After a two weeks washout period,in the Abstemious period, patients should not consume any kind of alcohol beverages, for 3 weeks |
Критерии за допустимост
Възрасти, отговарящи на условията за проучване | 45 Years Да се 45 Years |
Полове, допустими за проучване | Male |
Приема здрави доброволци | Да |
Критерии | Inclusion Criteria: 1. Men, 45-70 years 2. Established atherosclerotic diseases defined as: A. Previous history of CAD: angina or acute myocardial infarction (AMI), myocardial revascularization or angioplasty, angiographic evidence of stenosis ≥50% in at least one of the major coronary arteries B. Cerebrovascular disease: transient ischemic stroke or cerebrovascular accident C. Peripheral arterial disease: clinical evidence of extracoronary atherosclerosis Exclusion Criteria: 1. Acute events in the last 30 days (AMI, troponin elevation, coronary angioplasty or coronary artery bypass grafting) 2. Heart Failure (NYHA functional class ≥ II) 3. Renal Failure (clearance creatinine <30 mL / min by the Cockcroft-Gault formula) 4. Hepatic Failure 5. Gastro-intestinal cancer 6. Intestinal inflammatory diseases 7. Obstructive biliary diseases 8. Prior gastrointestinal surgeries: cholecystectomy or colectomy 9. Use of antibiotics within the last 2 months or during protocol 10. Alcoholism or alcohol intolerance 11. Diabetes mellitus or use of antidiabetics drugs |
Резултат
Първични изходни мерки
1. Gut flora modification assessed by 16S ribosomal rNA gene sequencing and plasma concentration of TMAO changes measured by liquid chromatography coupled to mass spectrometry in 42 patients after ingestion 250 mL of Red Wine 5 days/week, for 3 weeks [up to 10 weeks]