- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07668596
Independent and Combined Effects of Short-term Sulforaphane Supplementation and Exercise on Immunometabolism in Healthy Adults (EXSFN)
19. Juni 2026 aktualisiert von: Hashim Islam, University of British Columbia
Independent and Combined Effects of Short-term Sulforaphane Supplementation and Exercise on Immunometabolism in Healthy Adults: A Randomized Crossover Study
The study consist of 3 interventional periods which will be completed by each consenting participant in a randomized, crossover fashion.
The interventional periods will be separated by a minimum 1 week washout period.
One of the interventions consists of 4 days of daily supplementation with the commercially available broccoli sprout extract capsules (BrocElite).
Another intervention will consist of 4 days of daily supervised treadmill running.
The exercise protocol consists of 4 minutes of high-intensity running running followed by a 3 minute recovery period, repeated for a total of 4 repetitions.
The last intervention combines the above two and consists of 4 days of daily supplementation and daily supervised exercise training.
Before and after each intervention, basic anthropometrics (weight, heart rate, and blood pressure) will be recorded, and a venous blood sample will be collected.
Blood samples will be analyzed for metabolic and inflammatory markers.
Participants will be asked to refrain from structured exercise, alcohol consumption, and broccoli consumption during each of the experimental periods.
Before any testing, willing participants will provide informed consent, and fill out a few demographic, and lifestyle questionnaires.
The study will be conducted at the University of British Columbia in Kelowna, BC, Canada.
Studienübersicht
Status
Rekrutierung
Studientyp
Interventionell
Einschreibung (Geschätzt)
20
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienkontakt
- Name: Hashim Islam Principle Investigator, Ph.D
- Telefonnummer: 250-807-9122
- E-Mail: hashim.islam@ubc.ca
Studienorte
-
-
British Columbia
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Kelowna, British Columbia, Kanada, V1V 1V7
- Rekrutierung
- Reichwald Health Sciences Centre
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Kontakt:
- Sean McIntyre
- Telefonnummer: 2505757528
- E-Mail: smcint04@student.ubc.ca
-
-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
Akzeptiert gesunde Freiwillige
Ja
Beschreibung
Inclusion Criteria:
- aged between 18 and 35 years
- not a current smoker
- physically active based on the Canadian Physical Activity Guidelines (150 minutes of weekly physical activity)
Exclusion Criteria:
- a history of cardiometabolic diseases or respiratory diseases (e.g., chronic obstructive pulmonary disease, asthma, diabetes, coronary artery disease)
- currently following a ketogenic diet
- body mass index (BMI) over 30 kg/m2
- unable to read or communicate in English
- having received a vaccination or experienced an upper respiratory tract infection in the last 4 weeks
- having donated more than 0.5 L of blood within the last 4 weeks
- currently pregnant
- have contraindications to high intensity exercise (assessed using the CSEP Get Active Questionnaire)
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Grundlegende Wissenschaft
- Zuteilung: Zufällig
- Interventionsmodell: Crossover-Aufgabe
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: Sulforaphane Supplementation Only
In this intervention, participants will consume commercially available broccoli sprout extract capsules daily for 4 days (20 mg/day) .
Basic anthropometrics (weight, heart rate, blood pressure) and a venous blood sample (30 mL) will be collected before and after this interventional period.
|
Broc Elite Plus stabilized sulforaphane capsules from Mara Labs
|
|
Aktiver Komparator: Exercise Only
In this intervention, participants will complete supervised exercise sessions daily for 4 days.
The exercise intervention consists of interval running on a treadmill which contains 4 cycles of: 4 minutes of intense running (85-95% HRmax) followed by 3 minutes at a slow, easy pace.
Basic anthropometrics (weight, heart rate, blood pressure) and a venous blood sample (30 mL) will be collected before and after this interventional period.
|
4 cycles of: 4 minutes of intense treadmill running (85-95% HR max) followed by 3 minutes of slow, easy running.
|
|
Experimental: Sulforaphane Supplementation and Exercise
In this intervention, participants will consume commercially available broccoli sprout extract tablets daily for 4 days.
In addition, participants will complete supervised exercise sessions daily for 4 days.
The exercise intervention consists of interval running on a treadmill which contains 4 cycles of: 4 minutes of intense running (85-95% HRmax) followed by 3 minutes at a slow, easy pace.
Basic anthropometrics (weight, heart rate, blood pressure) and a venous blood sample (30 mL) will be collected before and after this interventional period.
|
Broc Elite Plus stabilized sulforaphane capsules from Mara Labs
4 cycles of: 4 minutes of intense treadmill running (85-95% HR max) followed by 3 minutes of slow, easy running.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change in peripheral blood mononuclear cell oxygen consumption rate
Zeitfenster: 0-4 days
|
OCR will be measured using a Seahorse Analyzer before and after each 4-day intervention
|
0-4 days
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
TNF-alpha secretion from LPS-stimulated whole blood
Zeitfenster: 0-4 days
|
TNF-alpha secretion from LPS-stimulated whole blood will be measured via ELISA before and after each 4-day period
|
0-4 days
|
|
Change in % of classical monocytes before and after the 6-week intervention
Zeitfenster: 0-4 days
|
The % of classical monocytes will be measured using flow cytometry at baseline and after the 4-day intervention
|
0-4 days
|
|
Change in % of intermediate monocytes before and after the 4-day intervention
Zeitfenster: 0-4 days
|
The % of intermediate monocytes will be measured using flow cytometry at baseline and after the 4-day intervention
|
0-4 days
|
|
Change in % of non-classical monocytes before and after the 4-day intervention
Zeitfenster: 0-4 days
|
The % of non-classical monocytes will be measured using flow cytometry at baseline and after the 4-day intervention
|
0-4 days
|
|
Change in TLR-4 expression on classical monocytes before and after the 4-day intervention
Zeitfenster: 0-4 days
|
TLR-4 expression on classical monocytes will be measured using flow cytometry at baseline and after the 4-day intervention.
|
0-4 days
|
|
Change in TLR-4 expression on intermediate monocytes before and after the 4-day intervention
Zeitfenster: 0-4 days
|
TLR-4 expression on intermediate monocytes will be measured using flow cytometry at baseline and after the 4-day intervention.
|
0-4 days
|
|
Change in TLR-4 expression on non-classical monocytes before and after the 4-day intervention
Zeitfenster: 0-4 days
|
TLR-4 expression on non-classical monocytes will be measured using flow cytometry at baseline and after the 4-day intervention
|
0-4 days
|
|
Change in white blood cell counts before and after the 4-day intervention
Zeitfenster: 0-4 days
|
White blood cell counts will be measured using a hematology analyzer at baseline and after the 4-day intervention
|
0-4 days
|
|
TNF-alpha secretion from PolyIC-stimulated whole blood
Zeitfenster: 0-4 days
|
TNF-alpha secretion from PolyIC-stimulated whole blood will be measured via ELISA before and after each 4-day period
|
0-4 days
|
|
Change in peripheral blood mononuclear cell extracellular acidification rate before and after the 4-day period
Zeitfenster: 0-4 days
|
PBMC ECAR will be measured using a Seahorse Analyzer at baseline and after the 4-day intervention
|
0-4 days
|
|
Change in PBMC mitotracker green staining before and after the 4-day period
Zeitfenster: 0-4 days
|
PBMC mitotracker green will be measured using flow cytometry before and after the 4-day intervention period
|
0-4 days
|
|
Change in PBMC mitoSOX red staining before and after the 4-day period
Zeitfenster: 0-4 days
|
PBMC mitoSOX red will be measured using flow cytometry before and after the 4-day intervention period
|
0-4 days
|
|
Change in PBMC mitochondrial respiration before and after the 4-day intervention period
Zeitfenster: 0-4 days
|
PBMC mitochondrial respiration will be measured using high-resolution respirometry before and after the 4-day period
|
0-4 days
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
1. März 2026
Primärer Abschluss (Geschätzt)
1. Dezember 2027
Studienabschluss (Geschätzt)
1. Juni 2028
Studienanmeldedaten
Zuerst eingereicht
19. Juni 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
19. Juni 2026
Zuerst gepostet (Tatsächlich)
25. Juni 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
25. Juni 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
19. Juni 2026
Zuletzt verifiziert
1. Juni 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- H25-03273
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
NEIN
Beschreibung des IPD-Plans
IPD will not be shared to ensure the privacy and confidentiality of participants, in accordance with ethical guidelines and data protection regulations.
Additionally, this was not included in the informed consent, which did not cover data sharing or address potential risks of re-identification.
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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