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Investigating the Bioavailability of Broccoli Extract Supplements

1. maj 2026 opdateret af: Emily Ho, Oregon State University

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)

Studieoversigt

Detaljeret beskrivelse

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).

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

12

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen

Tager imod sunde frivillige

Ja

Beskrivelse

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Grundvidenskab
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: 35 mg glucoraphanin
Participants will swallow by mouth 1 tablet of Avmacol Extra Strength with coating.
Participants will swallow by mouth 1 tablet Avamacol Extra Strength with coating (35 mg glucoraphanin per tablet)
Aktiv komparator: 60 mg glucoraphanin
Participants will chew and swallow by mouth 2 tablets of Avmacol chewable wafers (30 mg glucoraphanin each)
Participants will chew and swallow by mouth 2 wafers Avmacol chewable wafers (30 mg glucoraphanin per wafer)
Aktiv komparator: 70 mg glucoraphanin
Participants will swallow by mouth 2 tablets of Avmacol Extra Strength with coating (35 mg glucoraphanin each)
Participants will swallow by mouth 2 tablets Avamacol Extra Strength with coating (35 mg glucoraphanin per tablet)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Urine sulforaphane
Tidsramme: 0, 2, 4, 8, and 24 hours
Change from baseline levels of sulforaphane in urine
0, 2, 4, 8, and 24 hours
Urine sulforaphane metabolites
Tidsramme: 0, 2, 4, 8, and 24 hours
Change from baseline levels of sulforaphane in urine
0, 2, 4, 8, and 24 hours
Plasma glucoraphanin
Tidsramme: 0, 1, 2, 4, 8, and 24 hours
Change from baseline levels of plasma glucoraphanin
0, 1, 2, 4, 8, and 24 hours
Plasma sulforaphane
Tidsramme: 0, 1, 2, 4, 8, and 24 hours
Change from baseline levels of plasma sulforaphane
0, 1, 2, 4, 8, and 24 hours
Plasma sulforaphane metabolites
Tidsramme: 0, 1, 2, 4, 8, and 24 hours
Change from baseline levels of plasma sulforaphane metabolites
0, 1, 2, 4, 8, and 24 hours

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Emily Ho, PhD, Oregon State University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. september 2026

Primær færdiggørelse (Anslået)

1. september 2027

Studieafslutning (Anslået)

1. september 2028

Datoer for studieregistrering

Først indsendt

27. april 2026

Først indsendt, der opfyldte QC-kriterier

27. april 2026

Først opslået (Faktiske)

4. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

7. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. maj 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • LPI-2026-2211

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

We will not share IPD.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Kost, sund

Kliniske forsøg med Avmacol Extra Strength with coating - 1 tablet

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