Impact of Food Structure on Micronutrient Bioavailability in Human

NCT ID: NCT03413267

Last Updated: 2019-08-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-07
• Study Completion Date: 2018-04-19

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).

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.

Conditions

Food Structure Impact on Micronutrient Bioavailability

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Custard

Intervention Type: OTHER

Food matrix: custard (liquid emulsion)

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

Group Type: EXPERIMENTAL

Flan

Intervention Type: OTHER

Food matrix: flan (soft gel)

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

Group Type: EXPERIMENTAL

Sponge cake

Intervention Type: OTHER

Food matrix: sponge cake (porous and spongy)

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

Group Type: EXPERIMENTAL

Biscuit

Intervention Type: OTHER

Food matrix: biscuit (thick and crunchy)

Interventions

Custard

Food matrix: custard (liquid emulsion)

Intervention Type: OTHER

Flan

Food matrix: flan (soft gel)

Intervention Type: OTHER

Sponge cake

Food matrix: sponge cake (porous and spongy)

Intervention Type: OTHER

Biscuit

Food matrix: biscuit (thick and crunchy)

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Centre de Recherche en Nutrition Humaine d'Auvergne

OTHER_GOV

Sponsor Role: collaborator

University Hospital, Clermont-Ferrand

OTHER

Sponsor Role: collaborator

Université d'Auvergne

OTHER

Sponsor Role: collaborator

Françoise Nau

OTHER

Sponsor Role: lead

Responsible Party

Françoise Nau

PhD, Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Ruddy Richard, Prof

Role: PRINCIPAL_INVESTIGATOR

Centre de Recherche en Nutrition Humaine d'Auvergne

Locations

Centre de Recherche en Nutrition HUmaine d'Auvergne

Clermont-Ferrand, , France

Countries

France

Other Identifiers

2017-A01996-47

Identifier Type: OTHER

Identifier Source: secondary_id

MicroNut

Identifier Type: -

Identifier Source: org_study_id