Impact of Food Structure on Micronutrient Biovailability in Human
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Quantitative analysis of vitamin B9 and B12 in the liquid fraction of food boluses and characterization of these boluses
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
盲法说明
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.
入排标准
- 年龄范围
- 20 Years 至 30 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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
干预措施: Flan (Other)
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
干预措施: Custard (Other)
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
干预措施: Sponge cake (Other)
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
干预措施: Biscuit (Other)
结局指标
主要结局
Quantitative analysis of vitamin B9 and B12 in the liquid fraction of food boluses and characterization of these boluses
时间窗: 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
Quantitative analysis of vitamin D, B9, B12 and lutein in blood
时间窗: 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
次要结局
未报告次要终点
研究者
Françoise Nau
PhD, Professor
Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement