Food Structure Impact on Micronutrient Bioavailability Clinical Trial
Official title:
Impact of Food Structure on Micronutrient Biovailability in Human
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).
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.
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