NCT02709837

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2013

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

February 25, 2016

Completed
20 days until next milestone

First Posted

Study publicly available on registry

March 16, 2016

Completed
Last Updated

March 16, 2016

Status Verified

March 1, 2016

Enrollment Period

1 month

First QC Date

February 25, 2016

Last Update Submit

March 15, 2016

Conditions

Nutrition

Keywords

bioavailabilityamino acidcarnosinelycopenemasticationmeat

Outcome Measures

Primary Outcomes (3)

  • Postprandial plasma carnosine concentrations (µmole/L)

    effect of chewing efficiency and food processing

    7h

  • Postprandial plasma amino acid concentrations (µmol/L)

    effect of chewing efficiency and food processing

    7h

  • Postprandial plasma lycopene concentrations (µmol/L)

    effect of calcium addition

    7h

Secondary Outcomes (8)

  • Bolus particle size distribution (%)

    <1min

  • Bolus hardness (N)

    <1min

  • Bolus cohesiveness (dimensionless)

    <1min

  • Bolus elasticity (dimensionless)

    <1min

  • Bolus stickiness (N.s)

    <1min

  • +3 more secondary outcomes

Study Arms (4)

Poorly cooked meat-Good chewing

ACTIVE COMPARATOR

Meat cooked 10min at 75°C, chewing without appliance

Other: Nutritional

Highly cooked meat-Good chewing

ACTIVE COMPARATOR

Meat cooked 45min at 90°C, chewing without appliance

Other: Nutritional

Poorly cooked meat-Bad chewing

ACTIVE COMPARATOR

Meat cooked 10min at 75°C, chewing with appliance

Other: Nutritional

Highly cooked meat-Bad chewing

ACTIVE COMPARATOR

Meat cooked 45min at 90°C, chewing with appliance

Other: Nutritional

Interventions

NutritionalOTHER
Highly cooked meat-Bad chewingHighly cooked meat-Good chewingPoorly cooked meat-Bad chewingPoorly cooked meat-Good chewing

Eligibility Criteria

Age20 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Men or women
  • Women with contraception considered reliable by the investigator
  • ≤ age ≤ 30 years
  • Weight: ≥ 50kg
  • Good general health
  • Normal biological balance
  • 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

You may not qualify if:

  • 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)
  • 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
  • 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 ) .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 25, 2016

First Posted

March 16, 2016

Study Start

June 1, 2013

Primary Completion

July 1, 2013

Study Completion

January 1, 2014

Last Updated

March 16, 2016

Record last verified: 2016-03