NutritionDREAMNCT02709837
Impact of Food Process and Mastication on Nutrient Bioavailability
A study testing Nutritional in people with Nutrition, run by Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement.
Trial summary
This project aims at assessing the impact of heat treatment on the bioavailability of meat carnosine and amino acids, the interaction between masticatory efficiency and heat treatment of meat on the bioavailability of carnosine and amino acids the effect of dietary calcium on tomato lycopene bioavailability. Read more about this study
- Who is it for?
- Ages 20 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Nutrition
- What is being tested?
- Nutritional
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Jun 2013to Jan 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 20 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men or women
- Women with contraception considered reliable by the investigator
- 20 ≤ age ≤ 30 years
- Weight: ≥ 50kg
- Good general health
- Normal biological balance
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- Body mass index : 20 ≤ BMI ≤ 30
- Good oral and dental health
- Subjects having at least 28 teeth, tolerance for missing teeth if the number of functional units remains higher than or equal to 11, or if the number of metal rings does not exceed 4
- Subject whose dentition makes possible a stable Class I occlusion Angle to the molar level
- Subject considered healthy on clinical examination and medical examination
- Person who signed the information sheet and consent
- Person subject to a social security scheme
Who cannot join
- HCV or HIV positive Serology
- Biological assessment considered abnormal and not compatible with the study by the investigator.
- Pregnant or lactating
- medical or surgical history (judged by the investigator as not compatible with the study )
- People with neurological problems making atypical or dysfunctional swallowing (dysphagia ...)
- Medication may interfere with the results of the study ( muscle relaxants or psychotropic)
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- Blood donation within 8 weeks prior to the start of the study
- Oral surgery in the previous 12 months
- Subjects in dental care or having undergone orthodontic treatment in the previous 3 years
- Subject suffering or having suffered in the last month of the teeth , gums or mouth in general
- People with pain during chewing, pain in the face , mouth , jaw muscles, or loud creaking joints
- person under guardianship or not subject to a social security scheme
- Refusal to sign the information sheet and consent
- Refusal to be registered with the National Volunteer File
- Person in exclusion period another study , or who have received more than €4,500 in the year following his participation in clinical trials
- vegetarian or vegan or person not liking meat, tomato puree or pasta 17 diet without pork 18 important alcohol ( > 2 drinks / day or 20 g alcohol / day for women and > 3 drinks / day for men ) .
About this study
This project aims at assessing
- the impact of heat treatment on the bioavailability of meat carnosine and amino acids,
- the interaction between masticatory efficiency and heat treatment of meat on the bioavailability of carnosine and amino acids
- the effect of dietary calcium on tomato lycopene bioavailability.
Read the detailed description
This cross-over study (double 5x5 latin square design) includes 10 young healthy subjects (5 males, 5 females).These subjects are studied in two different situations: a situation of good chewing efficiency, and a situation of disturbed chewing. This second situation is simulated by the wearing an occlusal appliance interfering with chewing and experimentally leading to poor masticatory efficiency. The overall study is conducted in two distinct protocols. The first protocol "Food bolus" is dedicated to the study of the rheological properties of the food bolus including analysis of the release of amino acids and bioactive peptides (secondary objective). The second protocol "Bioavailability" is the study of the bioavailability of bioactive compounds target (main objective). Each volunteer participates in both protocols. The sessions, with or without occlusal appliance, are randomized individually for each subject. Each subject is his own control and confounding factors related to individual variability of mastication and the general functioning of the digestive tract are therefore minimized.
Meat model was pork (Longissimus dorsi). Meat was sliced 2 cm thick, and two types of cooking were applied: 10 min cooking at 75 ° C and 45 min cooking at 90 °C. Meat was presented to volunteers in the form of pre-calibrated cubes (2x2x2 cm) of about 7 g.
Protocol 1: Sampling for "food bolus" study This part of the study allowed a complete description of the physical / rheological properties of bolus after good or poor mastication of the pork meat cooked according to the 2 previously described conditions. The analysis of these properties is followed all along the chewing sequence, until bolus swallowing. For that, boli are collected at different moments during the sequence of mastication. Subjects stopped chewing when indicated by the experimenter, and spat out the entire bolus with the saliva. This protocol also allows the release of carnosine and amino acids from the meat matrix during mastication to be studied.
Protocol 2: Sampling for 'bioavailability' study The volunteers participated in five sampling days. The determination of the kinetics of appearance in peripheral blood of targeted bioactive compounds (carnosine, lycopene) as well as the release of all amino acids, is done after ingestion of a mixed meal (meat, tomato, pasta), under conditions of normal or poor chewing. Meal is prepared from 100 g of cooked meat (low cooking or high cooking meat), 40 g of tomato puree, 10 ml of olive oil, and 80 g of raw pasta. An additional meal containing calcium is tested in normal chewing condition with low cooking meat. Meals are tested on different days. These days are spaced by at least 7 days.
- Conditions
- Nutrition
- Being tested
- Nutritional
- Keywords
- bioavailability, amino acid, carnosine, lycopene, mastication, meat
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NutritionalOther
| Study group | Role | What they receive |
|---|---|---|
| Poorly cooked meat-Good chewing | Active comparator | Meat cooked 10min at 75°C, chewing without appliance Receives: Other: Nutritional |
| Highly cooked meat-Good chewing | Active comparator | Meat cooked 45min at 90°C, chewing without appliance Receives: Other: Nutritional |
| Poorly cooked meat-Bad chewing | Active comparator | Meat cooked 10min at 75°C, chewing with appliance Receives: Other: Nutritional |
| Highly cooked meat-Bad chewing | Active comparator | Meat cooked 45min at 90°C, chewing with appliance Receives: Other: Nutritional |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postprandial plasma carnosine concentrations (µmole/L)
effect of chewing efficiency and food processing
Measured: 7h
Postprandial plasma amino acid concentrations (µmol/L)
effect of chewing efficiency and food processing
Measured: 7h
Postprandial plasma lycopene concentrations (µmol/L)
effect of calcium addition
Measured: 7h
Secondary outcomes (8)
Bolus particle size distribution (%)
effect of chewing efficiency and food processing
Measured: <1min
Bolus hardness (N)
effect of chewing efficiency and food processing
Measured: <1min
Bolus cohesiveness (dimensionless)
effect of chewing efficiency and food processing
Measured: <1min
Bolus elasticity (dimensionless)
effect of chewing efficiency and food processing
Measured: <1min
Bolus stickiness (N.s)
effect of chewing efficiency and food processing
Measured: <1min
Bolus shear resistance (N/mm)
effect of chewing efficiency and food processing
Measured: <1min
Carnosine concentration in food bolus (µmole/L)
effect of chewing efficiency and food processing
Measured: <1min
Amino acid concentration in food bolus (µmol/L)
effect of chewing efficiency and food processing
Measured: <1min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2016 (estimated)
- Study startJun 2013
- Primary completionJul 2013
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NutritionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 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, Yves Boirie, Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02709837
- Sponsor's protocol ID
- AU 1030
- Other IDs
- 2013-A00096-39
- Acronym
- DREAM
- Status last verified
- Mar 2016
- First submitted
- 25 Feb 2016
- Last updated
- 16 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Food Process and Mastication on Nutrient Bioavailability
- ClinicalTrials.gov ID
- NCT02709837
- Acronym / sponsor ID
- DREAM / AU 1030
- Conditions
- Nutrition
- Keywords
- bioavailability, amino acid, carnosine, lycopene, mastication, meat
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 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
- Jun 2013
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 16 Mar 2016 (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.
This project aims at assessing
- the impact of heat treatment on the bioavailability of meat carnosine and amino acids,
- the interaction between masticatory efficiency and heat treatment of meat on the bioavailability of carnosine and amino acids
- the effect of dietary calcium on tomato lycopene bioavailability.
Detailed description
This cross-over study (double 5x5 latin square design) includes 10 young healthy subjects (5 males, 5 females).These subjects are studied in two different situations: a situation of good chewing efficiency, and a situation of disturbed chewing. This second situation is simulated by the wearing an occlusal appliance interfering with chewing and experimentally leading to poor masticatory efficiency. The overall study is conducted in two distinct protocols. The first protocol "Food bolus" is dedicated to the study of the rheological properties of the food bolus including analysis of the release of amino acids and bioactive peptides (secondary objective). The second protocol "Bioavailability" is the study of the bioavailability of bioactive compounds target (main objective). Each volunteer participates in both protocols. The sessions, with or without occlusal appliance, are randomized individually for each subject. Each subject is his own control and confounding factors related to individual variability of mastication and the general functioning of the digestive tract are therefore minimized.
Meat model was pork (Longissimus dorsi). Meat was sliced 2 cm thick, and two types of cooking were applied: 10 min cooking at 75 ° C and 45 min cooking at 90 °C. Meat was presented to volunteers in the form of pre-calibrated cubes (2x2x2 cm) of about 7 g.
Protocol 1: Sampling for "food bolus" study This part of the study allowed a complete description of the physical / rheological properties of bolus after good or poor mastication of the pork meat cooked according to the 2 previously described conditions. The analysis of these properties is followed all along the chewing sequence, until bolus swallowing. For that, boli are collected at different moments during the sequence of mastication. Subjects stopped chewing when indicated by the experimenter, and spat out the entire bolus with the saliva. This protocol also allows the release of carnosine and amino acids from the meat matrix during mastication to be studied.
Protocol 2: Sampling for 'bioavailability' study The volunteers participated in five sampling days. The determination of the kinetics of appearance in peripheral blood of targeted bioactive compounds (carnosine, lycopene) as well as the release of all amino acids, is done after ingestion of a mixed meal (meat, tomato, pasta), under conditions of normal or poor chewing. Meal is prepared from 100 g of cooked meat (low cooking or high cooking meat), 40 g of tomato puree, 10 ml of olive oil, and 80 g of raw pasta. An additional meal containing calcium is tested in normal chewing condition with low cooking meat. Meals are tested on different days. These days are spaced by at least 7 days.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Poorly cooked meat-Good chewing | Active comparator | Other: NutritionalMeat cooked 10min at 75°C, chewing without appliance |
| Highly cooked meat-Good chewing | Active comparator | Other: NutritionalMeat cooked 45min at 90°C, chewing without appliance |
| Poorly cooked meat-Bad chewing | Active comparator | Other: NutritionalMeat cooked 10min at 75°C, chewing with appliance |
| Highly cooked meat-Bad chewing | Active comparator | Other: NutritionalMeat cooked 45min at 90°C, chewing with appliance |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Men or women
- Women with contraception considered reliable by the investigator
- 20 ≤ age ≤ 30 years
- Weight: ≥ 50kg
- Good general health
Key exclusion criteria (16 listed)
- HCV or HIV positive Serology
- Biological assessment considered abnormal and not compatible with the study by the investigator.
- Pregnant or lactating
- medical or surgical history (judged by the investigator as not compatible with the study )
- People with neurological problems making atypical or dysfunctional swallowing (dysphagia ...)
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 |
|---|---|---|
| Nutritional | Other | Highly cooked meat-Bad chewing, Highly cooked meat-Good chewing, Poorly cooked meat-Bad chewing, Poorly cooked meat-Good chewing |
Primary outcome
Postprandial plasma carnosine concentrations (µmole/L)
Time frame: 7h
effect of chewing efficiency and food processing
Postprandial plasma amino acid concentrations (µmol/L)
Time frame: 7h
effect of chewing efficiency and food processing
Postprandial plasma lycopene concentrations (µmol/L)
Time frame: 7h
effect of calcium addition
8 secondary outcomes
Bolus particle size distribution (%)
Time frame: <1min
Bolus hardness (N)
Time frame: <1min
Bolus cohesiveness (dimensionless)
Time frame: <1min
Bolus elasticity (dimensionless)
Time frame: <1min
Bolus stickiness (N.s)
Time frame: <1min
Bolus shear resistance (N/mm)
Time frame: <1min
Carnosine concentration in food bolus (µmole/L)
Time frame: <1min
Amino acid concentration in food bolus (µmol/L)
Time frame: <1min
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 Mar 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Nutritional in people with Nutrition, run by Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement.
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 13 inclusion and 16 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 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Postprandial plasma carnosine concentrations (µmole/L) (time frame: 7h). The study lists 3 primary outcomes in all. 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 Mar 2016.