Impact of Food Structure on Micronutrient Bioavailability in Human

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).

Study Overview

• Status: Completed
• Conditions: Food Structure Impact on Micronutrient Bioavailability
• Intervention / Treatment: Other: Custard; Other: Flan; Other: Sponge cake; Other: Biscuit

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
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France, 63009
    • Centre de Récherche en Nutrition Humaine d'Auvergne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 30 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

4

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quantitative analysis of vitamin D, B9, B12 and lutein in blood	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	8 hours
Quantitative analysis of vitamin B9 and B12 in the liquid fraction of food boluses and characterization of these boluses	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	one and half hour

Collaborators and Investigators

• Sponsor: Françoise Nau
• Collaborators: University Hospital, Clermont-Ferrand; Université d'Auvergne; Centre de Recherche en Nutrition Humaine d'Auvergne
• Investigators: Principal Investigator: Ruddy Richard, Prof, Centre de Récherche en Nutrition Humaine d'Auvergne

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 7, 2017
• Primary Completion (ACTUAL): April 19, 2018
• Study Completion (ACTUAL): April 19, 2018

Study Registration Dates

• First Submitted: January 22, 2018
• First Submitted That Met QC Criteria: January 26, 2018
• First Posted (ACTUAL): January 29, 2018

Study Record Updates

• Last Update Posted (ACTUAL): August 20, 2019
• Last Update Submitted That Met QC Criteria: August 19, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: bioavailability; food texture; micronutrient; food structure; bioaccessibility
• Other Study ID Numbers: MicroNut; 2017-A01996-47 (OTHER: French Health Agency)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD 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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No