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临床试验/NCT04641026
NCT04641026进行中(未招募)不适用

Discovery of Biological Signatures for Cruciferous Vegetable Intake: Integration of the Broccoli- and Host-derived Metabolome and the Microbiome

Oregon State University1 个研究点 分布在 1 个国家目标入组 83 人开始时间: 2021年2月22日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
83
试验地点
1
主要终点
Urine sulforaphane

研究概览

简要总结

The purpose of this project is to study the molecular and metabolic profiles in human plasma, urine and microbiome composition following the consumption of broccoli sprouts.

详细描述

The investigators wish to examine metabolic and molecular markers found in blood and in urine after a single dose of sprouts, and evaluate the importance of the gut microbiome on these parameters. Some subjects will receive broccoli sprouts that are grown in deuterium oxide, a commonly used non-toxic, non-radioactive label for vegetables (Tang, Qin et al. 2005), so researchers can identify metabolites in blood and urine that are directly from consumed sprouts. The investigators plan to feed subjects a standardized breakfast and either broccoli sprouts or alfalfa sprouts (control) and look at the presence of metabolites and activity in the blood and urine 3, 6, 24, 48 and 72 hours following intake as well as changes in microbiome composition.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Single (Participant)

盲法说明

participant is blinded to the presence or absence of deuterium label

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Healthy men and women, 18-60 years of age
  • •Willing to stop taking herbal and phytochemical (plant-based extract or phytochemical) supplements for 1 week prior to and during the study
  • •Willing to stop cruciferous vegetable and probiotic supplement, food and beverage intake 1 week prior to and during the study
  • •Willing to complete a 10-day food diary during the study
  • •Must be able to give written informed consent

排除标准

  • •Body Mass Index (BMI) <18.5 or >30.0 kg/m2
  • •Tobacco use, including e-cigarettes, or smoking of any substance (e.g. cannabis) in the past three months
  • •Pregnancy, breastfeeding, or planning to become pregnant before completing the study
  • •Engaging in vigorous exercise more than 7 hours per week
  • •Have a significant acute or chronic illness such as cardiovascular disease, kidney or liver disease, diabetes, thyroid disorder, or radiation or chemotherapy treatment for cancer within the past five years.
  • •Use of medications to control cholesterol (e.g. statins, cholestyramine) or fat absorption (e.g. orlistat)
  • •Have had bariatric surgery (e.g. gastric bypass, gastric banding, sleeve gastrectomy, etc.), other gastrointestinal procedure (e.g. cholecystectomy) or disorders (e.g. Crohn's disease, celiac disease, ulcerative colitis)
  • •Use of oral antibiotic medication within the 6 months

研究组 & 干预措施

Broccoli sprouts

Active Comparator

Subjects will consume one serving (about 1 cup) of broccoli sprouts with breakfast (bagel, cream cheese, and orange juice).

干预措施: Broccoli sprouts (Other)

Deuterium oxide-labeled broccoli sprouts

Active Comparator

Subjects will consume one serving (about 1 cup) of deuterium oxide-labeled broccoli sprouts with breakfast (bagel, cream cheese, and orange juice).

干预措施: Deuterium oxide-labelled broccoli sprouts (Other)

Alfalfa sprouts

Placebo Comparator

Subjects will consume one serving (about 1 cup) of alfalfa sprouts with breakfast (bagel, cream cheese, and orange juice).

干预措施: Alfalfa sprouts (Other)

Deuterium oxide-labeled alfalfa sprouts

Placebo Comparator

Subjects will consume one serving (about 1 cup) of deuterium oxide-labeled alfalfa sprouts with breakfast (bagel, cream cheese, and orange juice).

干预措施: Deuterium oxide-labelled alfalfa sprouts (Other)

结局指标

主要结局

Urine sulforaphane

时间窗: Baseline, 3, 6, 24, 48 and 72 hours after consuming a single serving of sprouts

Change in levels of sulforaphane metabolites in urine

Plasma sulforaphane metabolites

时间窗: Baseline, 3, 6, 24, 48 and 72 hours after consuming a single serving of sprouts

Change in levels of sulforaphane metabolites in plasma

Urine sulforaphane metabolites

时间窗: Baseline, 3, 6, 24, 48 and 72 hours after consuming a single serving of sprouts

Change in levels of sulforaphane metabolites in urine

Plasma sulforaphane

时间窗: Baseline, 3, 6, 24, 48 and 72 hours after consuming a single serving of sprouts

Change in levels of sulforaphane in plasma

Stool sample based gut microbiome composition using 16S rRNA gene sequencing

时间窗: Baseline, 3, 6, 24, 48 and 72 hours after consuming a single serving of sprouts

Change in stool sample based gut microbiome composition using 16S rRNA gene sequencing

次要结局

未报告次要终点

研究者

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

Emily Ho

Endowed Chair and Director, Linus Pauling Institute Professor, College of Public Health and Human Sciences

Oregon State University

研究点 (1)

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