Investigating the Bioavailability of Broccoli Extract Supplements

Обзор

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)

Подробное описание

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).

Вмешательства

• Пищевая добавка Avmacol Extra Strength with coating - 1 tablet
  Participants will swallow by mouth 1 tablet Avamacol Extra Strength with coating (35 mg glucoraphanin per tablet)
• Пищевая добавка Avmacol chewable wafer - 2 tablets
  Participants will chew and swallow by mouth 2 wafers Avmacol chewable wafers (30 mg glucoraphanin per wafer)
• Пищевая добавка Avmacol Extra Strength with coating - 2 tablets
  Participants will swallow by mouth 2 tablets Avamacol Extra Strength with coating (35 mg glucoraphanin per tablet)

Первичные конечные точки

• Urine sulforaphane [Срок оценки: 0, 2, 4, 8, and 24 hours]
• Urine sulforaphane metabolites [Срок оценки: 0, 2, 4, 8, and 24 hours]
• Plasma glucoraphanin [Срок оценки: 0, 1, 2, 4, 8, and 24 hours]
• Plasma sulforaphane [Срок оценки: 0, 1, 2, 4, 8, and 24 hours]
• Plasma sulforaphane metabolites [Срок оценки: 0, 1, 2, 4, 8, and 24 hours]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Двойное слепое

Основная цель

Фундаментальное исследование

Центры проведения

США · 1 центр

• Oregon State University — Corvallis

Идентификаторы

NCT: NCT07564674 · LPI-2026-2211

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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