Impact of Food Structure on Micronutrient Bioavailability in Human

NCT03413267 | Completed

• 2 other identifiers: MicroNut2017-A01996-47
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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).

Conditions

Food Structure Impact on Micronutrient Bioavailability

Keywords

micronutrient; bioavailability; bioaccessibility; food structure; food texture

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (4)

Custard

EXPERIMENTAL

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

Flan

EXPERIMENTAL

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

Sponge cake

EXPERIMENTAL

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

Biscuit

EXPERIMENTAL

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

Interventions

Custard OTHER

Food matrix: custard (liquid emulsion)

Custard

Flan OTHER

Food matrix: flan (soft gel)

Flan

Sponge cake OTHER

Food matrix: sponge cake (porous and spongy)

Sponge cake

Biscuit OTHER

Food matrix: biscuit (thick and crunchy)

Biscuit

Eligibility Criteria

• Age: 20 Years - 30 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Françoise Nau: lead
• Centre de Recherche en Nutrition Humaine d'Auvergne: collaborator
• University Hospital, Clermont-Ferrand: collaborator
• Université d'Auvergne: collaborator

Study Sites (1)

Centre de Recherche en Nutrition HUmaine d'Auvergne

Clermont-Ferrand, 63009, France

Location

MeSH Terms

Interventions

BAG 0177

Study Officials

• Ruddy Richard, Prof

  Centre de Recherche en Nutrition Humaine d'Auvergne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Because the food matrices ingested by the volunteers have different aspects, no masking is really possible. However, blood samples will be analyzed by partners without knowledge of the matrix that has been ingested.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD, Professor

Model Details: 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.

Study Record Dates

• First Submitted: January 22, 2018
• First Posted: January 29, 2018
• Study Start: December 7, 2017
• Primary Completion: April 19, 2018
• Study Completion: April 19, 2018
• Last Updated: August 20, 2019

Record last verified: 2019-08

Locations

FR (1)