A Pilot Study to Investigate the Effect of Water-soluble Tomato Extract on TMAO

NCT04160481 | Completed

• 1 other identifier: 2018-08-07-RESV
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

To determine the effect of 4 weeks daily consumption of Fruitflow on changes in plasma levels of fasting Trimethylamine N-oxide concentrations (TMAO)

Conditions

Cardiovascular Risk Factor

Keywords

gut microbiome; carciovascular risk factor

Outcome Measures

Primary Outcomes (1)

• Change in TMAO concentrations

  Changes in plasma levels of fasting Trimethylamine N-oxide concentrations (TMAO) at baseline.

  4 weeks

Secondary Outcomes (6)

• Changes in the relative abundance of common human gut microbes in stool samples

  4 weeks

• Urinary TMAO

  4 weeks

• LPS

  4 weeks

• Stool consistency

  4 weeks

• Stool microbiota composition alpha diversity

  4 weeks

Study Arms (2)

Tomato extract

ACTIVE COMPARATOR

Dietary Supplement: FruitFlow

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Placebo

Interventions

FruitFlow DIETARY_SUPPLEMENT

300mg tomato extract

Tomato extract

Placebo DIETARY_SUPPLEMENT

Maltodextrin

Placebo

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be able to give written informed consent;
• Be between 35 and 65 years of age;
• Has a BMI between 28 - 35 Kg/m2;
• Has a stable body weight (≤5% change) over the past 3-months;
• Is in general good health, as determined by the investigator;
• Avoid consuming dietary supplements (prebiotic, probiotic, fibre, resveratrol, fish oil, seed oils, ginkgo biloba, ginseng, fruit powder extracts and DHA) within 4 weeks prior to baseline visit, until the end of the study;
• Avoid consuming seafood or fish 24h prior to each visit;
• Maintain current level of physical activity;
• Willing to consume the investigational product daily for the duration of the study.

You may not qualify if:

• Pregnant or breastfeeding women; women planning to become pregnant during the study;
• Are hypersensitive to any of the components of the test product;
• Has taken antibiotics within the previous 3 months;
• Has taken hypolipidemic agents or any treatment for diabetes (type I or II) within the previous 6 months;
• Has a history of drug and/or alcohol abuse at the time of enrolment;
• Consumes greater than 2 servings/day of alcohol (e.g. \>28 g ethanol/day);
• Is a smoker;
• Has made any major dietary changes in the past 3 months;
• Planned major changes in life style (i.e. diet, dieting, exercise level, travelling) during the duration of the study;
• Has an eating disorder;
• Is vegetarian/vegan diet or has food allergies or other issues with foods that would preclude intake of the study products;
• Is using fibre supplements or enemas;
• Has any health conditions that would prevent from fulfilling the study requirements, put the subject at risk or would confound the interpretation of the study results as judged by the investigator on the basis of medical history and routine laboratory test results;
• Have a significant acute or chronic coexisting illness such as cardiovascular disease, chronic kidney or liver disease, gastrointestinal disorder, endocrinological disorder, immunological disorder, metabolic disease or any condition which contraindicates, in the investigator's judgement, entry to the study;
• Current hepatic failure, renal failure, bleeding disorder (haemophilia, Von Willebrand disease, oesophageal varicoses);

Sponsors & Collaborators

• DSM Nutritional Products, Inc.: lead

Study Sites (1)

Atlantia Food Clinical Trials

Cork, Ireland

Location

Related Publications (6)

• Miller CA, Corbin KD, da Costa KA, Zhang S, Zhao X, Galanko JA, Blevins T, Bennett BJ, O'Connor A, Zeisel SH. Effect of egg ingestion on trimethylamine-N-oxide production in humans: a randomized, controlled, dose-response study. Am J Clin Nutr. 2014 Sep;100(3):778-86. doi: 10.3945/ajcn.114.087692. Epub 2014 Jun 18.

  PMID: 24944063 BACKGROUND

• Annunziata G, Maisto M, Schisano C, Ciampaglia R, Narciso V, Tenore GC, Novellino E. Effects of Grape Pomace Polyphenolic Extract (Taurisolo(R)) in Reducing TMAO Serum Levels in Humans: Preliminary Results from a Randomized, Placebo-Controlled, Cross-Over Study. Nutrients. 2019 Jan 10;11(1):139. doi: 10.3390/nu11010139.

  PMID: 30634687 BACKGROUND

• Bergeron N, Williams PT, Lamendella R, Faghihnia N, Grube A, Li X, Wang Z, Knight R, Jansson JK, Hazen SL, Krauss RM. Diets high in resistant starch increase plasma levels of trimethylamine-N-oxide, a gut microbiome metabolite associated with CVD risk. Br J Nutr. 2016 Dec;116(12):2020-2029. doi: 10.1017/S0007114516004165. Epub 2016 Dec 20.

  PMID: 27993177 BACKGROUND

• Cassidy A, Minihane AM. The role of metabolism (and the microbiome) in defining the clinical efficacy of dietary flavonoids. Am J Clin Nutr. 2017 Jan;105(1):10-22. doi: 10.3945/ajcn.116.136051. Epub 2016 Nov 23.

  PMID: 27881391 BACKGROUND

• Cardona F, Andres-Lacueva C, Tulipani S, Tinahones FJ, Queipo-Ortuno MI. Benefits of polyphenols on gut microbiota and implications in human health. J Nutr Biochem. 2013 Aug;24(8):1415-22. doi: 10.1016/j.jnutbio.2013.05.001.

  PMID: 23849454 BACKGROUND

• Rehman A, Tyree SM, Fehlbaum S, DunnGalvin G, Panagos CG, Guy B, Patel S, Dinan TG, Duttaroy AK, Duss R, Steinert RE. A water-soluble tomato extract rich in secondary plant metabolites lowers trimethylamine-n-oxide and modulates gut microbiota: a randomized, double-blind, placebo-controlled cross-over study in overweight and obese adults. J Nutr. 2023 Jan;153(1):96-105. doi: 10.1016/j.tjnut.2022.11.009. Epub 2022 Dec 23.

  PMID: 36913483 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, double-blind, placebo-controlled, cross-over

Study Record Dates

• First Submitted: November 8, 2019
• First Posted: November 13, 2019
• Study Start: November 12, 2019
• Primary Completion: March 13, 2020
• Study Completion: March 13, 2020
• Last Updated: March 26, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)