Investigating the Bioavailability of Broccoli Extract Supplements
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Urine sulforaphane
研究概览
简要总结
The goal of this clinical trial is to compare how much glucoraphanin and sulforaphane from 3 different versions of broccoli extract supplements is absorbed into the body and excreted in urine. This study involves generally healthy adults age 18-60 years. The supplements contain glucoraphanin and myrosinase enzyme, both naturally occurring in cruciferous vegetables. Once ingested, glucoraphanin is converted to the bioactive compound sulforaphane, which is thought to have numerous health benefits, including cancer prevention.
Participants will:
- consume 3 different versions of broccoli extract supplements (glucoraphanin will range from 35-70 mg)
- complete 3 separate 24 hour study cycles
- submit blood and urine samples for 24 hours
- follow diet restrictions (no cruciferous vegetables or condiments or phytochemical/herbal supplements for 1 week prior to and during each study cycle)
详细描述
This study aims to compare the bioavailability of 3 different versions of a broccoli extract supplement in generally healthy adults age 18-60 years who do not smoke or are not pregnant/lactating. The supplements contain glucoraphanin and myrosinase enzyme, both naturally occurring in cruciferous vegetables. Once ingested, glucoraphanin is converted to the bioactive compound sulforaphane, which is thought to have numerous health benefits, including cancer prevention. The amount of glucoraphanin that subjects will take will range from 35-70 mg. Glucoraphanin, sulforaphane, and sulforaphane metabolites will be measured in plasma and urine for 24 hours (plasma: 0, 0.5, 1, 2, 4, 8, and 24 hours after supplement consumption; urine: 0-2, 2-4, 4-8, and 8-24 hour after supplement consumption).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Participants will be blinded to the dose of glucoraphanin in each arm. Study staff analyzing samples will be blinded to treatment group.
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 adults, 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 each study cycle
- •Willing to stop cruciferous vegetable intake 1 week prior to and during each study cycle
- •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)
- •Allergic to broccoli, moringa, mustard, or maitake mushrooms
- •Weighs less than 110 pounds
- •Diagnosis of sickle cell disease
研究组 & 干预措施
35 mg glucoraphanin
Participants will swallow by mouth 1 tablet of Avmacol Extra Strength with coating.
干预措施: Avmacol Extra Strength with coating - 1 tablet (Dietary Supplement)
60 mg glucoraphanin
Participants will chew and swallow by mouth 2 tablets of Avmacol chewable wafers (30 mg glucoraphanin each)
干预措施: Avmacol chewable wafer - 2 tablets (Dietary Supplement)
70 mg glucoraphanin
Participants will swallow by mouth 2 tablets of Avmacol Extra Strength with coating (35 mg glucoraphanin each)
干预措施: Avmacol Extra Strength with coating - 2 tablets (Dietary Supplement)
结局指标
主要结局
Urine sulforaphane
时间窗: 0, 2, 4, 8, and 24 hours
Change from baseline levels of sulforaphane in urine
Urine sulforaphane metabolites
时间窗: 0, 2, 4, 8, and 24 hours
Change from baseline levels of sulforaphane in urine
Plasma glucoraphanin
时间窗: 0, 1, 2, 4, 8, and 24 hours
Change from baseline levels of plasma glucoraphanin
Plasma sulforaphane
时间窗: 0, 1, 2, 4, 8, and 24 hours
Change from baseline levels of plasma sulforaphane
Plasma sulforaphane metabolites
时间窗: 0, 1, 2, 4, 8, and 24 hours
Change from baseline levels of plasma sulforaphane metabolites
次要结局
未报告次要终点
研究者
Emily Ho
Endowed Chair and Director, Linus Pauling Institute; Professor, College of Health
Oregon State University