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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Institut National de la Recherche Agronomique

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Aix Marseille Université
Hôpital de la Conception

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 3, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 3, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 10, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 10, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 3, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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