Red Wine Effects Upon Gut Flora and Plasma Levels of Trimethylamine-N-oxide (TMAO) - WineFlora Study
Condition: Trimethylamine-N-oxide; Gut Microbiota; Effects of Red Wine; Atherosclerosis
MeSH terms: Atherosclerosis
Study type: Interventional

Summary: 
      Recent evidence indicates that Trimethylamine-N-oxide (TMAO) is a pro-atherosclerotic,
      phosphatidylcholine-dependent metabolite of diet and intestinal flora. Food substrates derive
      from carnitine and phosphatidylcholine (lecithin), present mainly in eggs, red meat, liver
      and pork. The intestinal flora pattern that favors the formation of TMAO is very similar to
      that which predisposes to insulin resistance and obesity: a high proportion between phylum
      Firmicutes over Bacteroidetes. The intestinal microbiota is sensitive and variable; the use
      of prebiotics and probiotics can change the relationship between Firmicutes/Bacteroidetes
      phyla. Red wine (RW), for its composition with polyphenols and possible bactericidal role,
      may play a role in the intestinal flora modification and could promote proliferation of
      beneficial bacteria. However, the influence of RW on TMAO is not known. This is the
      hypothesis to be tested in this trial. METHODS: This is a prospective, crossover, randomized,
      controlled trial with patients from Heart Institute (InCor), FMUSP and volunteers recruited
      through press releases. We will evaluate 42 patients, all men, with established
      atherosclerotic disease. Patients will be evaluated in a crossed manner: each subject
      receives both treatments, intervention and control (in random order), and they will be
      divided into 2 groups: A and B. In the first intervention stage, after 2 weeks of washout for
      all patients , group A receives Red Wine (RW) and group B is the control, abstemious. In the
      2nd stage of intervention, after 2 weeks of washout for all patients the groups are inverted:
      group B receives RW; and group A will be abstemious. In the period with wine intervention,
      patients will receive 250 mL/day of red wine per day, for 5 days of the week, for 3 weeks.
      Patients will maintain their usual diet without the use of prebiotics or probiotics, or other
      polyphenolic derivatives. At the beginning and at the end of each stage, patients will be
      submitted to serum TMAO and intestinal microbiota evaluation. For the intestinal microbiota
      evaluation, the new generation sequencing will be used in the highly preserved portion of the
      16S subunit of the rRNA gene. The determination of TMAO in plasma will be by liquid
      chromatography coupled to mass spectrometry. Expected results: It is expected to determine if
      RW acts on the intestinal flora to the point of influencing plasma TMAO concentration.
    


Intervention name(s): Red Wine consumption; Period without alcohol consumption
Intervention type(s): Dietary Supplement; Other
Intervention description(s): 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.; After a two weeks washout period,in the Abstemious period, patients should not consume any kind of alcohol beverages, for 3 weeks
Other intervention name(s): Abstain Period
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Forty two men with established atherosclerotic disease will be studied:after a 2 week washout period, each subject receives both treatments, intervention and control
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: trimethylamine-N-oxide; TMAO; Gut Microbiota; Gut Flora; Atherosclerosis; Wine; Red Wine