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Impact of Food Structure on Micronutrient Bioavailability in Human

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ClinicalTrials.gov Identifier: NCT03413267
Recruitment Status : Recruiting
First Posted : January 29, 2018
Last Update Posted : February 1, 2018
Sponsor:
Collaborators:
Centre de Recherche en Nutrition Humaine d'Auvergne
University Hospital, Clermont-Ferrand
University Clermont Auvergne , Faculté de Chirurgie dentaire
Information provided by (Responsible Party):
Françoise Nau, Institut National de la Recherche Agronomique

Brief Summary:

The nutritional quality of foods strongly depends on the structure / texture of foods, because of the impact on food disintegration, and then on digestion process and nutrient utilization by the human body. However, this relationship between food structure and nutrient bioavailability is still widely unknown.

MicroNut project aims at demonstrating and evaluating in humans the impact of structure / texture changes on micronutrient bioavailability. In order to do this, four complex food matrices, with constant composition but different structures / textures, and as close as possible to real foods have been designed and are evaluated in the present study. A mixture of egg and plant proteins is the basis of these lipoprotein matrices in which four micronutrients will be followed up : two lipophilic (vitamin D and lutein) and 2 hydrophilic (vitamins B9 and B12).


Condition or disease Intervention/treatment Phase
Food Structure Impact on Micronutrient Bioavailability Other: Custard Other: Flan Other: Sponge cake Other: Biscuit Not Applicable

Detailed Description:

The main objective consists in understanding how food structure / texture impacts on micronutrient bioavailability. The second objective consists in studying food disintegration at oral phase (in the mouth) and the consequences on the bioaccessibility of hydrophilic vitamins in saliva.

The clinical study is open, monocentric, controled and randomized, in a cross experimental design.

The included volunteers (n=12) will participate in the whole two protocols. The first protocol is related to the study of vitamins B9, B12, D and lutein bioavailability during 8h kinetics, after ingestion of a food matrix (custard, biscuit, flan or sponge cake). The second protocol is related to the study of hydrophilic vitamin release during mastication of two of these matrices (biscuit and sponge cake).

The study is not performed in a double blind way. However, the measure bias will be limited because of the standardized and objective characteristic of the main criteria. Moreover, biological samples will be analysed by the same partners of the project. Each subject will be his own control, so that confusion factors related to individual variability will be eliminated.

The monocentric characteristic of the study, the low number of subjects and the expertise of the involved staff will enable to limit the number of missing data.

The randomization (latin square) has been established by a bio-statistician of the project before the study started. A document describing the randomization proceeding is confidentially kept.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:

Bioavailability protocol : each volunteer participates in 4 interventions (4 food matrices), during 4 different days (one food matrix per day). At least 3 weeks between each intervention day. An intervention consists in food matrix ingestion (t=0) and blood sampling for 8 h postprandial (10 sampling times).

Mastication protocol : each volunteer participates in 1 session during which 2 solid matrices will be studied. For each matrix, 13 samples are proposed to the volunteer; food bolus are collected just before the volunteer feels the need of swallowing.

Masking: None (Open Label)
Masking Description: Because the food matrices ingested by the volunteers have different aspects, no masking is really possible. However, blood samples will be analyzed by partners without knowledge of the matrix that has been ingested.
Primary Purpose: Basic Science
Official Title: Impact of Food Structure on Micronutrient Biovailability in Human
Actual Study Start Date : December 7, 2017
Estimated Primary Completion Date : August 6, 2018
Estimated Study Completion Date : December 31, 2018

Arm Intervention/treatment
Experimental: Custard
The food matrix ingested (once by each volunteer) is a custard containing 1250µg vitamin D (=50 000 UI), 12µg vitamin B12, 1000µg vitamin B9 and 20 mg lutein
Other: Custard
Food matrix: custard (liquid emulsion)

Experimental: Flan
The food matrix ingested (once by each volunteer) is a flan containing 1250µg vitamin D (=50 000 UI), 12µg vitamin B12, 1000µg vitamin B9 and 20 mg lutein
Other: Flan
Food matrix: flan (soft gel)

Experimental: Sponge cake
The food matrix ingested (once by each volunteer) is a sponge cake containing 1250µg vitamin D (=50 000 UI), 12µg vitamin B12, 1000µg vitamin B9 and 20 mg lutein
Other: Sponge cake
Food matrix: sponge cake (porous and spongy)

Experimental: Biscuit
The food matrix ingested (once by each volunteer) is biscuits containing 1250µg vitamin D (=50 000 UI), 12µg vitamin B12, 1000µg vitamin B9 and 20 mg lutein
Other: Biscuit
Food matrix: biscuit (thick and crunchy)




Primary Outcome Measures :
  1. Quantitative analysis of vitamin D, B9, B12 and lutein in blood [ Time Frame: 8 hours ]
    Blood sampling before (T-30min to determine basal concentrations) and after food matrix ingestion (T0) for 8 h postprandial (10 sampling between 30 and 480min postprandial) for vitamin D, B9, B12 and lutein measurement in plasma; vitamin D and lutein will be quantified by HPLC-DAD in the chylomicron fraction; vitamin B9 and B12 will be quantified by ELISA method

  2. Quantitative analysis of vitamin B9 and B12 in the liquid fraction of food boluses and characterization of these boluses [ Time Frame: one and half hour ]
    Normal mastication of food matrix and splitting out for characterization of food bolus: granulometry, rheology and vitamin B9 and B12 release in the liquid fraction (saliva + food water + rinsing water); each volunteer successively masticates 13 samples of each solid food matrix (biscuit and sponge cake); vitamin B9 and B12 will be quantified by ELISA method



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 30 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • no smoking since 6 months at least
  • no pathology and no medical treatment
  • no history of calcium lithiasis
  • BMI >=20 and <=30 kg/m²
  • normal biological status
  • no dislike for the food tested
  • good dental health, no pain, no treatment in progress, no orthodontics since 3 years

Exclusion Criteria:

  • hypercalcemia (>2.52 mmol/L), hyperphosphoremia (>1.58 mmol/L)
  • known pathology
  • allergy or intolerance to one of the food matrix components (egg, vitamins B12, B9, D, lutein, pea, gluten)
  • intake of food supplements and/or UVdose for the 3 months before the study, except enriched foods
  • exposure to UV during the 2 weeks before the study and all along the study
  • vitamin D < 80µg/L

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03413267


Contacts
Contact: Françoise Nau, PhD +33 2 23 48 55 80 francoise.nau@agrocampus-ouest.fr
Contact: Ruddy Richard, Prof +33 4 73 60 82 50 ruddy.richard@udamail.fr

Locations
France
Centre de Recherche en Nutrition HUmaine d'Auvergne Recruiting
Clermont-Ferrand, France, 63009
Contact: Ruddy Richard, Prof    +33 4 73 60 82 50    ruddy.richard@udamail.fr   
Contact: Nathalie Meunier, PhD    +33 4 73 60 82 53    meunier@chu-clermontferrand.fr   
Principal Investigator: Ruddy Richard, Prof         
Sub-Investigator: Amandine Prulière         
Sub-Investigator: Françoise Laporte         
Sponsors and Collaborators
Françoise Nau
Centre de Recherche en Nutrition Humaine d'Auvergne
University Hospital, Clermont-Ferrand
University Clermont Auvergne , Faculté de Chirurgie dentaire
Investigators
Principal Investigator: Ruddy Richard, Prof Centre de Recherche en Nutrition Humaine d'Auvergne

Responsible Party: Françoise Nau, PhD, Professor, Institut National de la Recherche Agronomique
ClinicalTrials.gov Identifier: NCT03413267     History of Changes
Other Study ID Numbers: MicroNut
2017-A01996-47 ( Other Identifier: French Health Agency )
First Posted: January 29, 2018    Key Record Dates
Last Update Posted: February 1, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: De-identified individual participant data for all outcome measures will be made available, only after joined consent of promotor and investigator. Data use and transfer to a third party will be performed according to the agreement signed as part of the grant funded by Qualiment

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Françoise Nau, Institut National de la Recherche Agronomique:
micronutrient
bioavailability
bioaccessibility
food structure
food texture

Additional relevant MeSH terms:
Micronutrients
Trace Elements
Growth Substances
Physiological Effects of Drugs