- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07564674
Investigating the Bioavailability of Broccoli Extract Supplements
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
Status
Betingelser
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Emily Ho, PhD
- Telefonnummer: 541-737-9559
- E-mail: emily.ho@oregonstate.edu
Undersøgelse Kontakt Backup
- Navn: Sandra Uesugi, RN, BSN, MS
- Telefonnummer: 541-737-3594
- E-mail: sandra.uesugi@oregonstate.edu
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
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
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
Sponsor
Efterforskere
- Ledende efterforsker: Emily Ho, PhD, Oregon State University
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
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)?
IPD-planbeskrivelse
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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