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

April 3, 2018 updated by: Patrick Borel, Institut National de la Recherche Agronomique

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Marseille, France, 13005
        • Centre d'Investigation Clinique de la Hôpital Conception

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: lycopene
A dose of lycopene (20 mg) is provided as part of an emulsified liquid meal (with or without 160 mg powdered ferrous sulfate). Samples from the upper digestive tract (gastric or duodenal) are aspirated over 4 hours, and blood collected over 7 hours. Blood plasma and chylomicron fractions isolated. The subject returns for 3 additional visits with 2 weeks between each visit. The same protocol is followed, with the subject receiving all combinations of meal (w/ and w/o iron) and upper digestive tract sampling (gastric or duodenal)
Other: lycopene
A tomato oleoresin containing lycopene
Experimental: 13C beta-carotene
A dose of 13C beta-carotene (20 mg) is provided as part of an emulsified liquid meal. Samples from the upper digestive tract (gastric or duodenal) are aspirated over 5 hours, blood collected over 7 hours, and urine collected over 7 hours. Blood plasma and chylomicron fractions isolated. The subject returns for 1 additional visit with a minimum of 4 weeks between each visit. The same protocol is followed, with sampling taken from the remaining upper digestive tract compartment (gastric or duodenal)
Other: beta-carotene
13C beta-carotene
Placebo Comparator: control
The same procedure is followed (as detailed in the experimental arms) but the subject receives an emulsified liquid meal without carotenoids or vitamin E.
Other: control
emulsified liquid meal alone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Lycopene Metabolites
Time Frame: 7 hours
7 hours
beta-carotene metabolites
Time Frame: 7 hours
7 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut National de la Recherche Agronomique

Collaborators

Aix Marseille Université
Hôpital de la Conception

Investigators

  • Principal Investigator: Patrick Borel, PhD, INRA/INSERM/Université Aix-Marseille
  • Study Director: Catherine Caris-Veyrat, INRA/Université d'Avignon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2014

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

April 3, 2018

First Submitted That Met QC Criteria

April 3, 2018

First Posted (Actual)

April 10, 2018

Study Record Updates

Last Update Posted (Actual)

April 10, 2018

Last Update Submitted That Met QC Criteria

April 3, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013-A01398-37 (Registry Identifier: IDRCB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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