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奶制胆碱生物利用度

2026年9月28日 更新者:University of Wisconsin, Madison

评估新乳制品成分的胆碱生物利用度和新陈代谢的新代谢

The goal of this clinical trial is to find out if dairy is a good source of choline compared to eggs. The main questions it aims to answer are:

  • How the body uses choline; and,
  • What effect WPPC has on choline metabolism.

Researchers will compare Whey Protein Phospholipid Concentrate (WPPC) to whole egg powder to see if WPPC is as effective as eggs.

Participants will drink a chocolate-flavored smoothie mixed with either WPPC or whole egg powder.

研究概览

详细说明

This study is intended to evaluate the bioavailability and metabolism of choline in WPPC compared to the most commonly -used food for bioavailable choline, whole egg. The intent of the evaluation is to improve the knowledge of how WPPC contributes to the nutritional needs and health of postmenopausal women.

研究类型

介入性

注册 (估计的)

24

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

    • Wisconsin
      • Madison、Wisconsin、美国、53705
        • 招聘中
        • University of Wisconsin - Madison
        • 首席研究员:
          • Bradley Bolling, PhD
        • 接触:

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

51年 至 70年 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

女性

描述

Inclusion Criteria:

  • Ages between 51 and 70
  • Is currently post-menopausal (Post-menopausal is a term used to describe the time in a woman's life after she has gone through menopause. This usually happens between the ages of 45 and 55. Menopause is when a woman's menstrual periods stop permanently (at least 12 months))
  • Not allergic to the intervention foods and allergens that are related to the production of intervention foods (e.g. dairy products, egg, fish, peanut, shellfish, soy, tree nuts, wheat, crustaceans, gluten, mollusks, mustard, sesame seeds.)
  • Had stable body weight (± 5%) for the past 6 months
  • Free from cancer
  • Did not have weight loss surgery, colon surgery
  • Do not have chronic kidney diseases
  • Do not have malabsorption towards fat and dairy products
  • Willing to complete health surveys
  • Willing to complete two 4-day food diaries
  • Willing to consume the intervention smoothies
  • Willing to provide blood, urine, fecal samples at baseline and after 10 days of intervention

Exclusion Criteria:

  • On weight loss/weight gain diets
  • Diagnosed with fat malabsorption
  • Undergoing weight loss surgery
  • Diagnosed with chronic kidney diseases
  • Allergic to the intervention foods and allergens that are related to the production of intervention foods (e.g. dairy products, egg, chocolate, fish, peanut, shellfish, soy, tree nuts, wheat, crustaceans, gluten, mollusks, mustard, sesame seeds, banana, strawberry, raspberry, blackberry, blueberry.)
  • Regularly using antibiotics or probiotics or prebiotics
  • Regularly using weight-loss drugs (GLP-1, Orlistat, Cetilistat, etc.)
  • Regularly using laxatives
  • Unable to avoid strenuous exercise during the study (>4 h vigorous exercise per day)

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:其他
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的:Whey Protein Phospholipid Concentrate (WPPC)

Participants will drink a chocolate-flavored smoothie with WPPC added

A chocolate-flavored smoothie with WPPC added

实验性的:Pasteurized whole egg powder

Participants will drink a chocolate-flavored smoothie with egg powder added

A chocolate-flavored smoothie with whole egg powder added

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Change in circulating choline
大体时间:Baseline to 10 days

Circulating choline will be measured by UHPLC-HRMS/MS

Baseline to 10 days

次要结果测量

结果测量
措施说明
大体时间
Change in co-factors in circulating choline
大体时间:Baseline to 10 days

Co-factors in the circulation will be measured by ultrahigh performance liquid chromatography coupled with high resolution tandem mass spectrometry (UHPLC-HRMS/MS).

Baseline to 10 days
Change in high-sensitivity C-reactive protein (hs-CRP)
大体时间:Baseline to 10 days

Safety biomarker Hs-CRP will be measured using immunoturbidimetry.

Baseline to 10 days
Change in circulating choline metabolites
大体时间:Baseline to 10 days

Metabolites will be measured by UHPLC-HRMS/MS.

Baseline to 10 days
Change in 8-hydroxydeoxyguanosine
大体时间:Baseline to 10 days

The safety biomarker 8-hydroxydeoxyguanosine (8-OHDG) will be measured using enzyme-linked immunosorbent assay (ELISA).

Baseline to 10 days
Change in aspartate transaminase
大体时间:Baseline to 10 days

Aspartate transaminase (AST) will be measured using kinetic methods.

Baseline to 10 days
Change in alanine transaminase (ALT)
大体时间:Baseline to 10 days

Alanine transaminase will be measured using kinetic methods.

Baseline to 10 days
Change in creatinine
大体时间:Baseline to 10 days

Creatinine will be measured using kinetic methods

Baseline to 10 days

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Bradley Bolling, PhD、University of Wisconsin, Madison

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年9月18日

初级完成 (估计的)

2027年12月1日

研究完成 (估计的)

2027年12月1日

研究注册日期

首次提交

2025年3月24日

首先提交符合 QC 标准的

2025年3月24日

首次发布 (实际的)

2025年3月30日

研究记录更新

最后更新发布 (实际的)

2026年9月29日

上次提交的符合 QC 标准的更新

2026年9月28日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

其他研究编号

  • 2024-1661
  • A074000 (其他标识符:UW Madison)
  • CALS/FOOD SCIENCE (其他标识符:UW Madison)
  • Protocol Version 4/24/2026 (其他标识符:UW Madison)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

是的

IPD 计划说明

The research team will share the individual participant data collected during the trial after deidentification. Deidentified data will be stored and shared with DryAd and in accordance with all applicable regulations.

IPD 共享时间框架

Anticipated data availability will be immediately following publication. No end date.

IPD 共享访问标准

Data will be shared with DryAd. The data generated in this study will be housed in DryAd.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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