- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07668596
Independent and Combined Effects of Short-term Sulforaphane Supplementation and Exercise on Immunometabolism in Healthy Adults (EXSFN)
15 juillet 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Recrutement
Les conditions
Type d'étude
Interventionnel
Inscription (Estimé)
20
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Hashim Islam Principle Investigator, Ph.D
- Numéro de téléphone: 250-807-9122
- E-mail: hashim.islam@ubc.ca
Lieux d'étude
-
-
British Columbia
-
Kelowna, British Columbia, Canada, V1V 1V7
- Recrutement
- Reichwald Health Sciences Centre
-
Contact:
- Sean McIntyre
- Numéro de téléphone: 2505757528
- E-mail: smcint04@student.ubc.ca
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
Accepte les volontaires sains
Oui
La description
Inclusion Criteria:
- aged between 19 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)
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Science basique
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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
|
|
Comparateur actif: 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.
|
|
Expérimental: 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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in peripheral blood mononuclear cell oxygen consumption rate
Délai: 0-4 days
|
OCR will be measured using a Seahorse Analyzer before and after each 4-day intervention
|
0-4 days
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
TNF-alpha secretion from LPS-stimulated whole blood
Délai: 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 TLR-4 expression on classical monocytes before and after the 4-day intervention
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 0-4 days
|
PBMC mitochondrial respiration will be measured using high-resolution respirometry before and after the 4-day period
|
0-4 days
|
|
Change in percentage of classical monocytes before and after the 6-week intervention
Délai: 0-4 days
|
The percentage of classical monocytes will be measured using flow cytometry at baseline and after the 4-day intervention
|
0-4 days
|
|
Change in percentage of intermediate monocytes before and after the 4-day intervention
Délai: 0-4 days
|
The percentage of intermediate monocytes will be measured using flow cytometry at baseline and after the 4-day intervention
|
0-4 days
|
|
Change in percentage of non-classical monocytes before and after the 4-day intervention
Délai: 0-4 days
|
The percentage of non-classical monocytes will be measured using flow cytometry at baseline and after the 4-day intervention
|
0-4 days
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
1 mars 2026
Achèvement primaire (Estimé)
1 décembre 2027
Achèvement de l'étude (Estimé)
1 juin 2028
Dates d'inscription aux études
Première soumission
19 juin 2026
Première soumission répondant aux critères de contrôle qualité
19 juin 2026
Première publication (Réel)
25 juin 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
17 juillet 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
15 juillet 2026
Dernière vérification
1 juillet 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- H25-03273
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Description du régime IPD
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.
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .