Trials / Completed
CompletedNCT04160481
A Pilot Study to Investigate the Effect of Water-soluble Tomato Extract on TMAO
A Randomised, Double-blinded, Cross-over, Placebo- Controlled Pilot Study to Investigate the Effect of Tomato Extract on TMAO in Overweight or Obese Adults
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 37 (actual)
- Sponsor
- dsm-firmenich Switzerland AG · Industry
- Sex
- All
- Age
- 35 Years – 65 Years
- Healthy volunteers
- Accepted
Summary
To determine the effect of 4 weeks daily consumption of Fruitflow on changes in plasma levels of fasting Trimethylamine N-oxide concentrations (TMAO)
Detailed description
Tomatoes contain a range of polyphenols that are of low bioavailability and reach the colon. Data from animal studies suggest that certain polyphenols are extensively metabolized by the gut microbiota which may impact bioactivity including TMA/TMAO production. It was previously shown that a polyphenol-rich cranberry extract attenuated diet-induced metabolic syndrome in mice in a gut microbiota-dependent manner. In another mouse study the polyphenol resveratrol attenuated TMAO-induced atherosclerosis by decreasing TMAO levels and increasing hepatic bile acid neosynthesis via gut microbiota remodelling. However, human studies on polyphenol effect on TMAO levels and the gut microbiome are sparse. In a recent study TMAO serum levels were reduced in healthy subjects upon supplementation with a grape pomace polyphenolic extract. This clinical study will provide new insight into the effect of tomato extract on TMAO levels and the gut microbiota composition and thus potential new mechanisms responsible for the cardiovascular protective effects.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | FruitFlow | 300mg tomato extract |
| DIETARY_SUPPLEMENT | Placebo | Maltodextrin |
Timeline
- Start date
- 2019-11-12
- Primary completion
- 2020-03-13
- Completion
- 2020-03-13
- First posted
- 2019-11-13
- Last updated
- 2020-03-26
Locations
1 site across 1 country: Ireland
Source: ClinicalTrials.gov record NCT04160481. Inclusion in this directory is not an endorsement.