NCT03232099

Red Wine Effects Upon Gut Flora and Plasma Levels of Trimethylamine-N-oxide (TMAO) - WineFlora Study

Completed NA Last updated 15 March 2021

What this trial tests

NA trial testing Red Wine consumption in Trimethylamine-N-oxide in 42 participants. Completed in 15 April 2018.

Timeline

31 August 2016

Primary endpoint
22 March 2018

15 April 2018

Quick facts

Lead sponsor	University of Sao Paulo General Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	basic science
Enrollment	42
Start date	31 August 2016
Primary completion	22 March 2018
Estimated completion	15 April 2018

Drugs / interventions tested

• Red Wine consumption
• Period without alcohol consumption

Conditions studied

• Trimethylamine-N-oxide — all drugs for Trimethylamine-N-oxide →
• Gut Microbiota — all drugs for Gut Microbiota →
• Effects of Red Wine — all drugs for Effects of Red Wine →
• Atherosclerosis — all drugs for Atherosclerosis →

Sponsor

University of Sao Paulo General Hospital

Who can join

Adults 45 to 70, male only, with Trimethylamine-N-oxide or Gut Microbiota. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. A red wine intervention does not modify plasma trimethylamine N-oxide but is associated with broad shifts in the plasma metabolome and gut microbiota composition.
   Haas EA, Saad MJA, Santos A, Vitulo N, et al · · 2022 · cited 19× · PMID 36205549 · DOI 10.1093/ajcn/nqac286
2. Human gut microbiome: Therapeutic opportunities for metabolic syndrome-Hype or hope?
   Horvath A, Zukauskaite K, Hazia O, Balazs I, et al · · 2024 · cited 15× · PMID 37771199 · DOI 10.1002/edm2.436
3. Abstracts from the World Congress of Cardiology/Brazilian Congress of Cardiology 2022
   The Editorial Team (on behalf of the World Heart Federation). · · 2023