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临床试验/NCT04287816
NCT04287816已完成不适用

Achieving Nutritional Adequacy Of Vitamin E With An Egg/Plant-Based Food Pairing

Ohio State University1 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2021年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
8
试验地点
1
主要终点
Vitamin E Cmax

研究概览

简要总结

Malnutrition of the fat-soluble nutrient vitamin E (α-tocopherol; αT) is problematic. Since αT is rich in plant foods (e.g. spinach) that are mostly absent of accessible lipid, dietary patterns that can potentiate αT bioavailability by pairing vegetables with lipid-rich foods have been emphasized. The purpose of this study is to use deuterium-labeled spinach (containing stable isotopes of αT) to validate eggs as a dietary tool to improve αT bioavailability directly from a model plant food, and hence achieve nutrient adequacy. It is expected that compared with deuterium-labeled spinach alone, co-ingestion of eggs will dose- and time-dependently increase plasma bioavailability of spinach-derived deuterium-labeled αT without affecting time to maximal concentrations or half-lives. Further, phospholipid-rich egg yolk lipid will enhance nutrient bioavailability compared with vegetable oil. The outcome will therefore support an egg-based food pairing that can enhance the health benefits of plant-centric dietary patterns.

详细描述

In the US, 92-96% of men and women do not meet recommended intakes for αT. Dietary recommendations strongly encourage a diet rich in fruits and vegetables to meet dietary αT requirements. However, αT bioavailability from most plant foods is quite poor, thereby emphasizing a need for effective food pairings that can enhance the absorption and promote adequate status of these health-promoting nutrients. The objective of this application is to use deuterium-labeled spinach (containing stable isotopes of αT) to validate eggs as a dietary tool to improve αT bioavailability directly from a model plant food, and hence achieve nutrient adequacy. Our hypothesis is that the bioavailability of αT from deuterium-labeled spinach will be potentiated by egg intake in a dose-dependent manner by increasing their secretion in intestinal-derived chylomicrons. Furthermore, phospholipid-rich whole eggs will enhance spinach-derived αT bioavailability compared with vegetable oil, and will be most functionally responsible for the benefits of eggs to enhance nutrient absorption. Additionally, egg whites will more greatly promote nutrient bioaccessibility compared with spinach alone.

To test this, our specific aim is to assess egg-mediated improvements in αT bioavailability by conducting a cross-over pharmacokinetic study in healthy men and women. In Study Arms 1-4, participants will ingest deuterium-labeled spinach (containing 5 mg αT) with 0, 1, 2, or 3 hardboiled eggs (containing 0, 4.8, 9.6, or 14.4 g total fat, respectively). In Study Arm 5, participants will ingest spinach with two egg whites. In Study Arm 6, participants will ingest spinach with 9.6 grams of vegetable oil. In Study Arm 5, participants will ingest spinach alone followed by 1 egg 3-hours later. In Study Arm 7, participants will ingest spinach with 1 egg followed by another egg 3-hours later. In Study Arm 8, participants will ingest spinach with 1 egg followed by another egg 3-hours later. Thus, Study Arms 1-6 will test the dose-dependent and food matrix effects of eggs on αT bioavailability, and study Arms 7-8 will test the meal timing effects of eggs on αT bioavailability. Eucaloric diets will be controlled for αT intakes for 3 d prior to and during the initial 24 h of each trial to minimize heterogeneity of pharmacokinetic responses. Spinach-derived deuterium-labeled αT will be measured in plasma and isolated chylomicrons collected at timed intervals from 0-72 h post-meal ingestion, and biomarkers of antioxidant status and oxidative distress will be assessed at baseline (0 h) of each trial. Outcomes from this study are expected to demonstrate a dose- and time-dependent function of eggs to increase deuterium-labeled αT bioavailability (based on area under the curve (AUC) 0-72 h, Cmax, and % estimated absorption).

The rationale for this study is that, by establishing the efficacy of eggs to potentiate plant-derived fat-soluble nutrient bioavailability, a strong framework will exist for an easily implementable health-promoting food pairing strategy to overcome malnutrition of αT.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Crossover
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Body Mass Index (BMI) = 19-25 kg/m2
  • •Normolipidemic (total cholesterol <240 mg/dL; triglyceride <150 mg/dL)
  • •Fasting glucose <100 mg/dL
  • •Normal hematocrit level (41%-50% for men and 36%-48% for women)
  • •Normal hemoglobin level (13.5-17.5 g/dL for men and 12.0-15.5 g/dL for women)
  • •No use of dietary supplements for >1 month
  • •No use of medications that affect lipid or glucose metabolism
  • •Non-smoker
  • •No history of gastrointestinal disorders

排除标准

  • •Egg allergy
  • •Alcohol intake > 2 drinks per day
  • •Aerobic activity >7 h/wk
  • •Body mass change >2 kg in the past 1 month
  • •Women who are pregnant, lactating, or initiated or changed birth control in the past 3 month
  • •Vegetarian

研究组 & 干预措施

Zero hard-boiled egg at 0 h

Experimental

No eggs will be consumed on the test day. Deuterium-labeled spinach containing 5 mg αT will be ingested alone prior to the 72-h pharmacokinetics trial.

干预措施: Zero hard-boiled egg at 0 h (Other)

One hard-boiled egg at 0 h

Experimental

Deuterium-labeled spinach containing 5 mg αT will be ingested along with 1 hard-boiled egg prior to the 72-h pharmacokinetics trial.

干预措施: One hard-boiled egg at 0 h (Other)

Two hard-boiled eggs at 0 h

Experimental

Deuterium-labeled spinach containing 5mg αT will be ingested along with 2 hard-boiled eggs prior to the 72-h pharmacokinetics trial.

干预措施: Two hard-boiled eggs at 0 h (Other)

Three hard-boiled eggs at 0 h

Experimental

Deuterium-labeled spinach containing 5 mg αT will be ingested along with 3 hard-boiled eggs prior to the 72-h pharmacokinetics trial.

干预措施: Three hard-boiled eggs at 0 h (Other)

One hard-boiled egg at 3 h

Experimental

Deuterium-labeled spinach containing 5 mg αT will be ingested alone at 0 h prior to the 72-h pharmacokinetics trial followed by 1 hard-boiled egg 3 hours after spinach consumption.

干预措施: One hard-boiled egg at 3 h (Other)

One hard-boiled egg at 0 h + One hard-boiled egg at 3 h

Experimental

Deuterium-labeled spinach containing 5 mg αT will be ingested along with 1 hard-boiled egg at 0 h prior to the 72-h pharmacokinetics trial followed by 1 egg 3 hours after spinach consumption.

干预措施: One hard-boiled egg at 0 h + One hard-boiled egg at 3 h (Other)

Two egg whites at 0 h

Experimental

Deuterium-labeled spinach containing 5 mg αT will be ingested along with two egg whites prior to the 72-h pharmacokinetics trial.

干预措施: Two egg whites at 0 h (Other)

Vegetable oil at 0 h

Experimental

Deuterium-labeled spinach containing 5 mg αT will be ingested along with 9.6 grams of vegetable oil prior to the 72-h pharmacokinetics trial.

干预措施: Vegetable oil at 0 h (Other)

结局指标

主要结局

Vitamin E Cmax

时间窗: 0-72 hours post-ingestion of spinach

Maximum plasma concentration of deuterium-labeled alpha-tocopherol

Vitamin E Area Under the Curve (0-72 h)

时间窗: 0, 3, 4.5, 6, 7.5, 9, 12, 24, 36, 48, 72 hours post-ingestion of spinach

Area under the concentration-time curve of plasma deuterium-labeled alpha-tocopherol over 72 hours post ingestion.

次要结局

  • Chylomicron Vitamin E(0, 3, 4.5, 6, 7.5, 9, 12 hours post-ingestion of spinach)
  • Estimated Absorption (%Dose) of Vitamin E(0-72 hours post-ingestion of spinach)
  • Chylomicron Vitamin E(0, 3, 4.5, 6, 7.5, 9, 12 hours post-ingestion of spinach)
  • Vitamin E Tmax (hr)(0-72 hours post-ingestion of spinach)
  • Half-Life (hr)(0-72 hours post-ingestion of spinach)
  • Estimated Absorption (%Dose) of Vitamin E(0-72 hours post-ingestion of spinach)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Richard Bruno

Professor and Principal Investigator

Ohio State University

研究点 (1)

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