Impact of Food Structure on Micronutrient Bioavailability in Human
Condition: Food Structure Impact on Micronutrient Bioavailability
Study type: Interventional

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).
    

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.
    

Intervention name(s): Custard; Flan; Sponge cake; Biscuit
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Food matrix: custard (liquid emulsion); Food matrix: flan (soft gel); Food matrix: sponge cake (porous and spongy); Food matrix: biscuit (thick and crunchy)
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)
Primary purpose: Basic Science
Keywords: micronutrient; bioavailability; bioaccessibility; food structure; food texture