奶制胆碱生物利用度
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
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Kevin Shih
- 电话号码:919-338-9453
- 邮箱:sshih22@wisc.edu
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:
- Kevin Shih
- 邮箱:sshih22@wisc.edu
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
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
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
调查人员
- 首席研究员:Bradley Bolling, PhD、University of Wisconsin, Madison
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
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)?
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
研究美国 FDA 监管的设备产品
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