Impact of Food Process and Mastication on Nutrient Bioavailability (DREAM)

March 15, 2016 updated by: Yves Boirie, Institut National de la Recherche Agronomique

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

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

20 years to 30 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Men or women
  2. Women with contraception considered reliable by the investigator
  3. 20 ≤ age ≤ 30 years
  4. Weight: ≥ 50kg
  5. Good general health
  6. Normal biological balance
  7. Body mass index : 20 ≤ BMI ≤ 30
  8. Good oral and dental health
  9. 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
  10. Subject whose dentition makes possible a stable Class I occlusion Angle to the molar level
  11. Subject considered healthy on clinical examination and medical examination
  12. Person who signed the information sheet and consent
  13. Person subject to a social security scheme

Exclusion Criteria:

  1. HCV or HIV positive Serology
  2. Biological assessment considered abnormal and not compatible with the study by the investigator.
  3. Pregnant or lactating
  4. medical or surgical history (judged by the investigator as not compatible with the study )
  5. People with neurological problems making atypical or dysfunctional swallowing (dysphagia ...)
  6. Medication may interfere with the results of the study ( muscle relaxants or psychotropic)
  7. Blood donation within 8 weeks prior to the start of the study
  8. Oral surgery in the previous 12 months
  9. Subjects in dental care or having undergone orthodontic treatment in the previous 3 years
  10. Subject suffering or having suffered in the last month of the teeth , gums or mouth in general
  11. People with pain during chewing, pain in the face , mouth , jaw muscles, or loud creaking joints
  12. person under guardianship or not subject to a social security scheme
  13. Refusal to sign the information sheet and consent
  14. Refusal to be registered with the National Volunteer File
  15. Person in exclusion period another study , or who have received more than €4,500 in the year following his participation in clinical trials
  16. 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 ) .

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Poorly cooked meat-Good chewing
Meat cooked 10min at 75°C, chewing without appliance
Active Comparator: Highly cooked meat-Good chewing
Meat cooked 45min at 90°C, chewing without appliance
Active Comparator: Poorly cooked meat-Bad chewing
Meat cooked 10min at 75°C, chewing with appliance
Active Comparator: Highly cooked meat-Bad chewing
Meat cooked 45min at 90°C, chewing with appliance

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postprandial plasma carnosine concentrations (µmole/L)
Time Frame: 7h
effect of chewing efficiency and food processing
7h
Postprandial plasma amino acid concentrations (µmol/L)
Time Frame: 7h
effect of chewing efficiency and food processing
7h
Postprandial plasma lycopene concentrations (µmol/L)
Time Frame: 7h
effect of calcium addition
7h

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bolus particle size distribution (%)
Time Frame: <1min
effect of chewing efficiency and food processing
<1min
Bolus hardness (N)
Time Frame: <1min
effect of chewing efficiency and food processing
<1min
Bolus cohesiveness (dimensionless)
Time Frame: <1min
effect of chewing efficiency and food processing
<1min
Bolus elasticity (dimensionless)
Time Frame: <1min
effect of chewing efficiency and food processing
<1min
Bolus stickiness (N.s)
Time Frame: <1min
effect of chewing efficiency and food processing
<1min
Bolus shear resistance (N/mm)
Time Frame: <1min
effect of chewing efficiency and food processing
<1min
Carnosine concentration in food bolus (µmole/L)
Time Frame: <1min
effect of chewing efficiency and food processing
<1min
Amino acid concentration in food bolus (µmol/L)
Time Frame: <1min
effect of chewing efficiency and food processing
<1min

Collaborators and Investigators

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

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

June 1, 2013

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

February 25, 2016

First Submitted That Met QC Criteria

March 15, 2016

First Posted (Estimate)

March 16, 2016

Study Record Updates

Last Update Posted (Estimate)

March 16, 2016

Last Update Submitted That Met QC Criteria

March 15, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • AU 1030
  • 2013-A00096-39 (Other Identifier: Comité de Protection des Personnes Sud-Est 6)

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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