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Completed

NCT Number: NCT03492593

Lycopene and Beta-carotene Metabolism in the Digestive Tract of Healthy Men

Consumption of foods containing carotenoids, as well as vitamin E, have been associated with lower risk of developing a number of chronic diseases. While the parent compounds have largely been assumed to exert protective antioxidant effects, more recent work has suggested that metabolites may be bioactive. Very little attention has been given to the metabolism of these compounds during the digestive process. Our primary aim is to conduct a postprandial feeding study in healthy men to determine the stability of carotenoids and vitamin E during digestion, and to identify the primary metabolites produced in various compartments of the upper gastrointestinal tract and blood during digestion. Targeted metabolites will be identified and quantitated using high-performance liquid chromatography-tandem mass spectrometry methods previously developed. In addition, a non-targeted metabolomics approach will be used to identify non-predicted metabolites in the samples. A better understanding of carotenoid and vitamin E stability and metabolism during digestion will provide greater insight into how these compounds may confer protection against chronic disease.

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Key information

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Centre d'Investigation Clinique de la Hôpital Conception

Marseille, 13005, France

About this study

Consumption of foods containing the carotenoids lutein, lycopene, beta-carotene, as well as vitamin E, have been associated with lower risk of developing chronic diseases including cardiovascular disease, cancer, age related macular degeneration, and cognitive decline. While the parent compounds have largely been assumed to exert protective antioxidant effects, more recent work has suggested that metabolites may be bioactive. Very little attention has been given to the metabolism of these compounds during the digestive process. Our primariy aim is to conduct a postprandial feeding study in healthy men to determine the stability of carotenoids and vitamin E during digestion, and to identify the primary metabolites produced in the upper gastrointestinal tract during digestion. Subjects will be fed a meal containing either lutein,lycopene, deuterated beta-carotene, or deuterated vitamin E. Gastric and duodenal samples will be taken 5 hours post-meal consumption, while blood plasma and chylomicron fractions will be taken over 7 hours post-meal consumption. Targeted metabolites will be identified and quantitated using high-performance liquid chromatography-tandem mass spectrometry methods previously developed. In addition, a non-targeted metabolomics approach will be used to identify non-predicted metabolites in a subset of collected samples. Overall, this research will provide very original insight about carotenoid and vitamin E metabolites produced during the digestive process and their absorption by the human body. This information is essential to understand how these compounds may confer protection against chronic disease.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • BMI of 18-29.9
  • Cholesterol < 2.2 g/L
  • Triglycerides < 1.5 g/L
  • Blood sugar </= 1.1 g/L
  • Hemoglobin > 13 g/dL
  • Test negative for hepatitis B, C, and HIV

Exclusion criteria

  • Hepatitis B and C
  • HIV
  • Blood donation or blood sampling less than 2 months prior to the first daylong study day
  • Craniofacial trauma
  • Smokers
  • Regular consumption of vitamins or supplements rich in carotenoids or vitamin E in the past 3 months
  • Alcohol consumption > 140 g per week (equivalent to 14 glasses of wine, 14 glasses of beer (25 mL), or 14 shots of liquor).
  • Past or present eating disorder (anorexia, bulimia, etc.)
  • Food allergies to components of the liquid test meal
  • Medical treatment or surgical intervention affecting the digestive tract or function of the digestive tract
  • Metabolic disorders (disorder of the liver or pancreas, diabetes, hemochromatosis, gastro-intenstinal disorders with the exception of appendicitis)
  • Use of certain medications (those which regulate intestinal transit, those which reduce blood lipids and cholesterol, those which interact with bile salts)
  • All medical indications which fall within the context of exclusion criteria as determined by the supervising physician of the study
  • Intense physical activity > 4 1/2 hours per week
  • Participation in another clinical study

Treatment and study plan

lycopene

Other

A tomato oleoresin containing lycopene

beta-carotene

Other

13C beta-carotene

Control

Other

emulsified liquid meal alone

Primary outcomes

  1. Lycopene Metabolites

    Time frame: 7 hours

  2. beta-carotene metabolites

    Time frame: 7 hours

Sponsors and collaborators

Lead sponsor

Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement

Other

Collaborators

  • Aix Marseille Université
  • Hôpital de la Conception

Registry information

Official study title

Métabolismes Des caroténoïdes Dans la lumière du Tube Digestif de l'Homme Sain

Acronym: CarotenoiDig

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Apr 10, 2018
Registry last updated
Apr 10, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.