- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07668596
Independent and Combined Effects of Short-term Sulforaphane Supplementation and Exercise on Immunometabolism in Healthy Adults (EXSFN)
15 juli 2026 uppdaterad av: 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.
Studieöversikt
Status
Rekrytering
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Beräknad)
20
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Hashim Islam Principle Investigator, Ph.D
- Telefonnummer: 250-807-9122
- E-post: hashim.islam@ubc.ca
Studieorter
-
-
British Columbia
-
Kelowna, British Columbia, Kanada, V1V 1V7
- Rekrytering
- Reichwald Health Sciences Centre
-
Kontakt:
- Sean McIntyre
- Telefonnummer: 2505757528
- E-post: smcint04@student.ubc.ca
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
Tar emot friska volontärer
Ja
Beskrivning
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)
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Grundläggande vetenskap
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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
|
|
Aktiv 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.
|
|
Experimentell: 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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in peripheral blood mononuclear cell oxygen consumption rate
Tidsram: 0-4 days
|
OCR will be measured using a Seahorse Analyzer before and after each 4-day intervention
|
0-4 days
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
TNF-alpha secretion from LPS-stimulated whole blood
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 mars 2026
Primärt slutförande (Beräknad)
1 december 2027
Avslutad studie (Beräknad)
1 juni 2028
Studieregistreringsdatum
Först inskickad
19 juni 2026
Först inskickad som uppfyllde QC-kriterierna
19 juni 2026
Första postat (Faktisk)
25 juni 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
17 juli 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
15 juli 2026
Senast verifierad
1 juli 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- H25-03273
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
IPD-planbeskrivning
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.
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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