Lycopene and Beta-carotene Metabolism in the Digestive Tract of Healthy Men
CarotenoiDig
Métabolismes Des caroténoïdes Dans la lumière du Tube Digestif de l'Homme Sain
1 other identifier
interventional
20
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2016
CompletedFirst Submitted
Initial submission to the registry
April 3, 2018
CompletedFirst Posted
Study publicly available on registry
April 10, 2018
CompletedApril 10, 2018
April 1, 2018
1.5 years
April 3, 2018
April 3, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Lycopene Metabolites
7 hours
beta-carotene metabolites
7 hours
Study Arms (3)
lycopene
EXPERIMENTALA 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)
13C beta-carotene
EXPERIMENTALA 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)
control
PLACEBO COMPARATORThe same procedure is followed (as detailed in the experimental arms) but the subject receives an emulsified liquid meal without carotenoids or vitamin E.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
- Intense physical activity \> 4 1/2 hours per week
- Participation in another clinical study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centre d'Investigation Clinique de la Hôpital Conception
Marseille, 13005, France
Related Publications (1)
Kopec RE, Caris-Veyrat C, Nowicki M, Gleize B, Carail M, Borel P. Production of asymmetric oxidative metabolites of [13C]-beta-carotene during digestion in the gastrointestinal lumen of healthy men. Am J Clin Nutr. 2018 Oct 1;108(4):803-813. doi: 10.1093/ajcn/nqy183.
PMID: 30256893DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Patrick Borel, PhD
INRA/INSERM/Université Aix-Marseille
- STUDY DIRECTOR
Catherine Caris-Veyrat
INRA/Université d'Avignon
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 3, 2018
First Posted
April 10, 2018
Study Start
September 1, 2014
Primary Completion
March 1, 2016
Study Completion
March 1, 2016
Last Updated
April 10, 2018
Record last verified: 2018-04