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Completed

NCT Number: NCT03413267

Impact of Food Structure on Micronutrient Bioavailability 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).

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Key information

Conditions

Food Structure Impact on Micronutrient Bioavailability

Age range

20 year–30 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Centre de Recherche en Nutrition HUmaine d'Auvergne

Clermont-Ferrand, 63009, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Custard

Other

Food matrix: custard (liquid emulsion)

Flan

Other

Food matrix: flan (soft gel)

Sponge cake

Other

Food matrix: sponge cake (porous and spongy)

Biscuit

Other

Food matrix: biscuit (thick and crunchy)

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Françoise Nau

Other

Collaborators

  • Centre de Recherche en Nutrition Humaine d'Auvergne
  • University Hospital, Clermont-Ferrand
  • Université d'Auvergne

Registry information

Official study title

Impact of Food Structure on Micronutrient Biovailability in Human

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jan 29, 2018
Registry last updated
Aug 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.