Colorectal CancerNCT02473302
Preventive Strategies in Colorectal Carcinogenesis Production and Meat Processing
A study testing ham, ham + pomegranate extract and ham + tocopherol in people with Colorectal Cancer, run by Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement at 1 site in France.
Trial summary
Colorectal Cancer is, in non-smokers for both sex, first cause of cancers mortality in Western country. The main risk factors associated with colorectal cancer depend of lifestyle, and processed meat and red meat could be involved in carcinogenesis by cytotoxic and genotoxic compound linked to lipid peroxidation and… Read more about this study
- Who is it for?
- Ages 40 to 75 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- ham, ham + pomegranate extract and ham + tocopherol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2014to Jul 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male
- Body mass index 20 <= BMI <= 30 kg/m2
- Affiliated to French National Health Insurance
- Subject giving his written informed consent
- Subject considered as normal after clinical examination and medical questionnaire
Who cannot join
- Previous medical and/or surgery judged by the investigator as incompatible with this study
- Previous familial of colon, ovarian or breast cancer
- Chronic pathologies : cardiovascular diseases, cancer, chronic inflammation diseases, renal, intestinal impairments
- Dislike ham or red meat
- Heavy consumer of alcohol
- Practising intensive physical exercise (> 5 hours)
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- Being under someone's supervision
- Refusal to be registered on the National Volunteers Data file
- Dietary habits unreliable to controlled food intake
- Being in exclusion on the National Volunteers Data file
Trial locations and contacts
1 site in 1 country.
About this study
Colorectal Cancer is, in non-smokers for both sex, first cause of cancers mortality in Western country.
The main risk factors associated with colorectal cancer depend of lifestyle, and processed meat and red meat could be involved in carcinogenesis by cytotoxic and genotoxic compound linked to lipid peroxidation and nitrosation.
The aim of this study is to study the impact of the daily consumption of beef, processed or not, on lipid peroxidation induced heme iron ; and to study the impact of the daily consumption of ham, processed or not, on the nitrosilation induced heme iron.
Read the detailed description
24 healthy volunteers will be randomized and will start the study. The study will last 12 weeks for each subject. The first week will be a week of adaptation (or run-in period) to the diet which they will have to follow for the duration of study. During this period, they will collect 3 samples of stools and urine. Then subjects will alternate 4 days of diet either with ham, or with ham and pomegranate extract, or with ham enriched with vitamin E or sirloin steak, marinated sirloin steak or marinated cooked sirloin steak. At least, 3 days will separate every period (wash-out) of nutritional intervention. Urines and stools will be collected last 3 days of every interventional period and also last day of every wash out period.
- Conditions
- Colorectal Cancer
- Being tested
- ham, ham + pomegranate extract, ham + tocopherol, rare sirloin steak, marinated rare sirloin steak
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hamOther
160g per day during 4 days
ham + pomegranate extractOther
160g per day during 4 days
ham + tocopherolOther
160g per day during 4 days
rare sirloin steakOther
110g per day during 4 days
marinated rare sirloin steakOther
110g per day during 4 days
marinated cooked sirloin steakOther
110g per day during 4 days
| Study group | Role | What they receive |
|---|---|---|
| ham | Placebo comparator | 160g per day during 4 days Receives: Other: ham |
| ham + pomegranate extract | Experimental | 160g per day during 4 days Receives: Other: ham + pomegranate extract |
| ham + tocopherol | Experimental | 160g per day during 4 days Receives: Other: ham + tocopherol |
| rare sirloin steak | Placebo comparator | 110g per day during 4 days Receives: Other: rare sirloin steak |
| marinated rare sirloin steak | Experimental | 110g per day during 4 days Receives: Other: marinated rare sirloin steak |
| marinated cooked sirloin steak | Experimental | 110g per day during 4 days Receives: Other: marinated cooked sirloin steak |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fecal marker
TBARS Fecal for red meat pane and NOCs Fecal for ham
Measured: 12 weeks
Secondary outcomes (6)
NOC
Fecal marker for red meat pane
Measured: 12 weeks
cytotoxic activity of fecal water
Fecal marker for red meat pane
Measured: 12 weeks
DHN-MA
urinary marker for red meat pane
Measured: 12 weeks
TBARs
Fecal marker for ham
Measured: 12 weeks
cytotoxic activity of fecal water
Fecal marker for ham
Measured: 12 weeks
DHN-MA
urinary marker for ham
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2015 (estimated)
- Study startApr 2014
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
- Sponsor type
- University, hospital or other
- Collaborators
- Centre de Recherche en Nutrition Humaine d'Auvergne
- Responsible party
- Principal investigator, Adeline BLOT, University Hospital, Clermont-Ferrand
- Investigators
- Fabrice PIERRE, Phd, Study chair, Institut National de Recherche pour l'Agriculture, l'Alimentation et l'EnvironnementNoel CANO, Md, Phd, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02473302
- Sponsor's protocol ID
- Securiviande
- Status last verified
- Jun 2015
- First submitted
- 12 Jun 2015
- Last updated
- 16 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventive Strategies in Colorectal Carcinogenesis Production and Meat Processing
- ClinicalTrials.gov ID
- NCT02473302
- Acronym / sponsor ID
- Securiviande
- Conditions
- Colorectal Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Institut National de Recherche pour l'Agriculture, l'Alimentation et l'EnvironnementUniversity, hospital or other
- Collaborators
- Centre de Recherche en Nutrition Humaine d'Auvergne
- Study start
- Apr 2014
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 16 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Colorectal Cancer is, in non-smokers for both sex, first cause of cancers mortality in Western country.
The main risk factors associated with colorectal cancer depend of lifestyle, and processed meat and red meat could be involved in carcinogenesis by cytotoxic and genotoxic compound linked to lipid peroxidation and nitrosation.
The aim of this study is to study the impact of the daily consumption of beef, processed or not, on lipid peroxidation induced heme iron ; and to study the impact of the daily consumption of ham, processed or not, on the nitrosilation induced heme iron.
Detailed description
24 healthy volunteers will be randomized and will start the study. The study will last 12 weeks for each subject. The first week will be a week of adaptation (or run-in period) to the diet which they will have to follow for the duration of study. During this period, they will collect 3 samples of stools and urine. Then subjects will alternate 4 days of diet either with ham, or with ham and pomegranate extract, or with ham enriched with vitamin E or sirloin steak, marinated sirloin steak or marinated cooked sirloin steak. At least, 3 days will separate every period (wash-out) of nutritional intervention. Urines and stools will be collected last 3 days of every interventional period and also last day of every wash out period.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| ham | Placebo comparator | Other: ham160g per day during 4 days |
| ham + pomegranate extract | Experimental | Other: ham + pomegranate extract160g per day during 4 days |
| ham + tocopherol | Experimental | Other: ham + tocopherol160g per day during 4 days |
| rare sirloin steak | Placebo comparator | Other: rare sirloin steak110g per day during 4 days |
| marinated rare sirloin steak | Experimental | Other: marinated rare sirloin steak110g per day during 4 days |
| marinated cooked sirloin steak | Experimental | Other: marinated cooked sirloin steak110g per day during 4 days |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male
- Body mass index 20 <= BMI <= 30 kg/m2
- Affiliated to French National Health Insurance
- Subject giving his written informed consent
- Subject considered as normal after clinical examination and medical questionnaire
Key exclusion criteria (10 listed)
- Previous medical and/or surgery judged by the investigator as incompatible with this study
- Previous familial of colon, ovarian or breast cancer
- Chronic pathologies : cardiovascular diseases, cancer, chronic inflammation diseases, renal, intestinal impairments
- Dislike ham or red meat
- Heavy consumer of alcohol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ham160g per day during 4 days | Other | ham |
| ham + pomegranate extract160g per day during 4 days | Other | ham + pomegranate extract |
| ham + tocopherol160g per day during 4 days | Other | ham + tocopherol |
| rare sirloin steak110g per day during 4 days | Other | rare sirloin steak |
| marinated rare sirloin steak110g per day during 4 days | Other | marinated rare sirloin steak |
| marinated cooked sirloin steak110g per day during 4 days | Other | marinated cooked sirloin steak |
Primary outcome
Fecal marker
Time frame: 12 weeks
TBARS Fecal for red meat pane and NOCs Fecal for ham
6 secondary outcomes
NOC
Time frame: 12 weeks
cytotoxic activity of fecal water
Time frame: 12 weeks
DHN-MA
Time frame: 12 weeks
TBARs
Time frame: 12 weeks
cytotoxic activity of fecal water
Time frame: 12 weeks
DHN-MA
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fabrice PIERRE, Phd study chair
Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
Noel CANO, Md, Phd principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ham, ham + pomegranate extract and ham + tocopherol in people with Colorectal Cancer, run by Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fecal marker (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2015.