Effect of Co-consuming Different Dietary Protein Sources With Salad on the Bioavailability of Carotenoids
2026年8月30日 更新者:Jung Eun Kim、National University of Singapore
The goal of this clinical trial is to learn if different protein types will affect carotenoid responses in humans when co-consumed with salad. The main questions it aims to answer are:
- What are the effect of dietary protein co-consumption with salad on postprandial carotenoid levels in Singapore adults?
- Do different whole-food protein sources enhance the bioavailability of carotenoids in Singapore adults?
Participants will:
Consume salad with a form of protein (chicken, tuna, egg, soybean) Have their postprandial plasma carotenoid and triglyceride outcomes evaluated
研究概览
地位
尚未招聘
详细说明
This study will be a single-blind, randomized, crossover acute trial, and all participants will complete an approximately 3-month study period.
A total of 19 participants will be recruited and go through all 5 arms (4 intervention and 1 control), with the order randomized.
The study will comprise 1 screening visit and 5 test visits, with another 5 compliance visits.
研究类型
介入性
注册 (估计的)
19
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
- 姓名:Wei Xi Khu, B.Sc.
- 电话号码:+65 9359 8952
- 邮箱:E0773498@u.nus.edu
学习地点
-
-
-
Singapore、新加坡、117542
- NUS, Department of Food Science and Technology, 1 Science Drive 3, Block S13, #03-07, Singapore, 117542
-
首席研究员:
- Jung Eun Kim, Ph.D., R.D.
-
接触:
- Wei Xi Khu, B.Sc.
- 电话号码:+65 93598952
- 邮箱:E0773498@u.nus.edu
-
-
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
- 成人
接受健康志愿者
是的
描述
Inclusion Criteria:
- English-literate and able to give informed consent
- Singaporean Adults aged 21 to 45 (inclusive)
- Body mass index of 18.5 to 23.0 kg/m2 (inclusive)
- At least 50 kg
- Healthy (based on screening results)
Exclusion Criteria:
- Currently participating in another clinical study that involves altering regular diet and/or involves consuming a dietary supplement or investigated food product as an intervention
- High blood pressure (≥ 140/90 mmHg)
- Underlying health conditions that may affect metabolic functions
- Consuming carotenoid supplements regularly (i.e., more than three times a week) for the past 3 months, and not willing to discontinue consumption 3 months before and during the study duration
- Weight change > 3 kg in the past 3 months
- Exercising vigorously over the past 3 months (i.e., engaging in high-intensity exercises for more than 3 hours a week, where high-intensity exercises leave one out of breath and unable to talk or sing during the workout)
- Current smokers or have quit smoking for less than 5 years
- Drinking > 2 alcoholic drinks per day (i.e., one drink is defined as either 150 ml of wine, 340 ml of beer/cider or 45 ml of distilled spirit)
- If drinking ≤ 2 alcoholic drinks per day, not willing to stop consumption of alcoholic beverages two days before and on the day of the test visits
- Not willing to stop consumption of caffeinated beverages 10 to 12 hours before and on the day of the test visits
- Currently on a specialised diet (e.g., vegetarian, vegan, weight loss diet)
- Had serious food allergies in the past, or having intolerance, sensitivities or allergies to any of the following: soy/soy-derived products, eggs, fish and crustaceans, starch/starch-derived products (e.g., rice, corn, wheat, potato), gluten
- Disease or impairment of the liver
- Currently diagnosed with diabetes, gastrointestinal issues (e.g., lactose intolerance, irritable bowel syndrome), gout and/or G6PD deficiency
- Taking antibiotics 2 weeks prior to study participation
- Taking anti-hypertensive or cholesterol-lowering drugs for less than 3 years unless medically declared by an official doctor to be in stable condition
- Poor peripheral venous access based on past experiences with blood drawing
- Individuals with pacemaker or related electrical medical devices
- Pregnant, lactating, or planning pregnancy in the next 6 months
- Have donated blood (whole blood or apheresis) or participated in any other clinical study or trial requiring blood draws within the last 3 months
- Clinical anemia (hemoglobin <12.0 g/dL in women and <13.0 g/dL in men)
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:预防
- 分配:随机化
- 介入模型:交叉作业
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
安慰剂比较:Salad only
Salad only (no protein)
|
Control group, consumption of only salad
|
|
实验性的:Salad + Chicken
Salad with chicken
|
Consumption of salad with chicken
|
|
实验性的:Salad + Tuna
Salad with tuna
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Consumption of salad with tuna
|
|
实验性的:Salad + Egg
Salad with egg
|
Consumption of salad with egg
|
|
实验性的:Salad + Soybean
Salad with soybeans
|
Consumption of salad with soybean
|
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 |
|---|---|---|
|
Concentration of plasma carotenoids
大体时间:From start of salad consumption to the end of acute period (8 hours)
|
Concentration of plasma carotenoids hourly
|
From start of salad consumption to the end of acute period (8 hours)
|
|
Concentration of blood triglycerides
大体时间:From start of salad consumption to the end of acute period (8 hours)
|
Postprandial triglyceride response
|
From start of salad consumption to the end of acute period (8 hours)
|
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:Jung Eun Kim, Ph.D., R.D.、National University of Singapore, Department of Food Science and Technology
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 (估计的)
2026年9月1日
初级完成 (估计的)
2027年2月1日
研究完成 (估计的)
2027年2月1日
研究注册日期
首次提交
2026年8月26日
首先提交符合 QC 标准的
2026年8月26日
首次发布 (实际的)
2026年8月31日
研究记录更新
最后更新发布 (实际的)
2026年9月2日
上次提交的符合 QC 标准的更新
2026年8月30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
- S37
- NUS-IRB-2026-590 (其他标识符:National University of Singapore Institutional Review Board (NUS IRB))
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
不
IPD 计划说明
Electronic copies of the data with identifiable participant information will be kept on NUS OneDrive with access limited only to Dr Kim Jung Eun and her research staff.
All data will be de-identified prior to statistical analyses.
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.