- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07461194
Timing of Broccoli Sprout Intake to Improve Exercise Performance
Effects of Acute and Subacute Intake of Broccoli Sprouts Intake on Exercise Performance and Recovery
Study Overview
Status
Intervention / Treatment
Detailed Description
This is a randomized, double-blind, placebo-controlled cross-over study conducted at the Swedish School of Sport and Health Sciences (GIH), Stockholm, designed to isolate the effect of timing of isothiocyanate (ITC) intake from broccoli sprouts on exercise responses, recovery, and cycling performance. Each participant completes four laboratory visits: one screening/physiology visit and three intervention visits. The screening visit includes a health check and an incremental cycle test to determine maximal oxygen uptake and to individualize exercise intensities for subsequent visits; oxygen uptake is assessed by indirect calorimetry, and capillary fingertip samples are used to measure blood lactate and glucose during the test. A venous blood sample is collected at the screening visit.
Intervention visits (three separate occasions) follow the same standardized test-day structure with different drink assignments according to randomization. The active drink consists of 50 g broccoli sprouts (ITC source) and the placebo drink consists of 50 g alfalfa sprouts. Drinks are administered to compare "subacute" intake (approximately 16 hours before exercise, the evening prior) versus "acute" intake (approximately 3 hours before exercise, the morning of the test day). The three intervention conditions are: (1) placebo at ~16 h plus placebo at ~3 h before the cycling protocol (control), (2) active at ~16 h plus placebo at ~3 h (subacute condition), and (3) placebo at ~16 h plus active at ~3 h (acute condition). Participants and investigators/test staff are blinded to drink identity at each visit.
On each intervention test day, participants arrive to the laboratory (approximately 08:30) and compliance with pre-visit instructions is checked. Baseline samples are collected, including a muscle biopsy from vastus lateralis, venous blood, and saliva. Participants then complete a standardized, strenuous cycling protocol on an ergometer with individualized intensity based on the screening test (approximately 80% of VO2max). An example structure is repeated intervals around lactate threshold (e.g., 8 × 5 min work with short recovery), with physiological monitoring throughout. Heart rate is recorded continuously (smartwatch), and capillary blood lactate and glucose are measured at predefined time points during exercise. Oxygen uptake/energy metabolism may be monitored during portions of the protocol using indirect calorimetry.
The exercise protocol includes a 10 km cycling performance test on the ergometer. In addition, approximately 4 hours after completion of the initial cycling bout (and following the relevant sampling time point), participants perform a second 10 km ergometer time trial in which they are instructed to perform as well as possible. Perceived exertion is recorded during exercise, and perceived recovery is assessed during the recovery period (e.g., Perceived Recovery Status Scale).
Biological sampling is extensive to characterize acute and post-exercise recovery processes. At each intervention visit, venous blood is collected at 10 time points: pre-exercise, immediately post-exercise, and then once per hour during the subsequent 8-hour laboratory recovery period (approximately 4 mL per draw; ~40 mL per intervention visit). Muscle biopsies from vastus lateralis are collected at four time points per intervention visit: pre-exercise, immediately post-exercise, approximately 4 hours post-exercise, and approximately 24 hours post-exercise (separate incision sites; predetermined/randomized leg). Saliva sampling is also performed (including at baseline and at the end of the ~8-hour laboratory recovery period). During the 0-8 hour recovery period in the laboratory, standardized meals are provided.
After approximately 8 hours in the laboratory, participants leave and return the next day (~24 hours after exercise) for final sampling, including the last muscle biopsy. For the 24-hour visit, participants fast for at least 10 hours. A glucose tolerance test is performed at the 24-hour follow-up to assess post-exercise glucose regulation.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Filip J Larsen, PhD
- Phone Number: 08-120 53 700
- Email: filip.larsen@gih.se
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Healthy, endurance-trained adults aged 18-64 years.
Regular endurance training (e.g., cycling/running) and ability to complete a standardized 2-hour high-intensity cycling session on an ergometer.
Approved health declaration and screening assessment by study staff (including that ergometer testing can be performed safely).
Willing and able to follow the study protocol (diet/fasting instructions, standardized training before visits, attendance at all four laboratory visits).
No known allergy/hypersensitivity to ingredients in the broccoli sprout drink or placebo drink.
Exclusion Criteria:
Does not meet inclusion criteria at screening (e.g., abnormal health declaration or medical findings making intense endurance exercise or muscle biopsy inappropriate).
Known allergy/hypersensitivity to ingredients in the intervention or placebo drink (broccoli/cruciferous vegetables or alfalfa) or other relevant food allergy.
Ongoing illness, fever, or infection at any test occasion, or other acute medical event judged to affect safety or data quality.
Ongoing treatment with medications/supplements judged to affect primary outcomes or increase risk (e.g., anti-inflammatory medication close to test days per study instructions).
Pregnancy (if women are included) or breastfeeding.
Inability to comply with the study protocol (e.g., failure to standardize diet/fasting, deviating training/alcohol intake despite instructions, or repeated missed visits).
Participant withdraws consent or investigator judges continued participation to pose risk.
-
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: placebo
Participants ingest placebo drink prepared from alfalfa sprouts (50 g) ~16 hours before exercise (evening prior) and placebo drink (50 g) ~3 hours before exercise (test day morning).
Exercise protocol and sampling are identical to other conditions.
|
The placebo intervention is a drink prepared from alfalfa sprouts (50g per dose) as a placebo.
Participants ingest the drink at both ~16 hours before the exercise session (evening prior) and ~3 hours before the exercise session (test day morning).
The study compares the timing of ITC intake versus placebo, with identical procedures across conditions.
|
|
Experimental: active, ~16 hours pre exercise
Participants ingest broccoli sprout drink (isothiocyanate-rich; 50 g sprouts) ~16 hours before exercise and placebo alfalfa sprout drink (50 g) ~3 hours before exercise.
Exercise protocol and sampling are identical to other conditions.
|
Active intervention is a drink prepared from broccoli sprouts (50 g per dose) as a natural source of glucosinolates/isothiocyanates (ITCs).
Participants ingest the drink either ~16 hours before the exercise session (evening prior) or ~3 hours before the exercise session (test day morning), depending on randomized condition.
The study compares the timing of ITC intake versus placebo, with identical procedures across conditions.
|
|
Experimental: active, ~3 hours pre exercise
Participants ingest placebo alfalfa sprout drink (50 g) ~16 hours before exercise and broccoli sprout drink (isothiocyanate-rich; 50 g sprouts) ~3 hours before exercise.
Exercise protocol and sampling are identical to other conditions.
|
Active intervention is a drink prepared from broccoli sprouts (50 g per dose) as a natural source of glucosinolates/isothiocyanates (ITCs).
Participants ingest the drink either ~16 hours before the exercise session (evening prior) or ~3 hours before the exercise session (test day morning), depending on randomized condition.
The study compares the timing of ITC intake versus placebo, with identical procedures across conditions.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Lactate
Time Frame: During exercise and across the 0 to 8 hours recovery period (hourly venous samples), and at the follow-up, approximately 24 hours post-exercise.
|
blood lactate (mmol/L) at predefined time points during exercise; venous sampling schedule as per protocol.
|
During exercise and across the 0 to 8 hours recovery period (hourly venous samples), and at the follow-up, approximately 24 hours post-exercise.
|
|
Glucose
Time Frame: During exercise and across the 0 to 8 hours recovery period (hourly venous samples), and at the follow-up, approximately 24 hours post-exercise.
|
Blood glucose (mmol/L) at predefined time points during exercise; venous sampling schedule as per protocol.
|
During exercise and across the 0 to 8 hours recovery period (hourly venous samples), and at the follow-up, approximately 24 hours post-exercise.
|
|
Glycogen
Time Frame: Before exercise, immediately post-exercise, 8 hours post-exercise, and 24 hours post-exercise
|
Muscle glycogen content in the vastus lateralis obtained from biopsies at pre-exercise, immediately post-exercise, 8 hours post-exercise, and 24 hours post-exercise to quantify glycogen depletion during exercise and repletion during recovery
|
Before exercise, immediately post-exercise, 8 hours post-exercise, and 24 hours post-exercise
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Physical performance
Time Frame: Twice per visit. First, immediately following the standardized cycling protocol, and second, 4 hours post-exercise during the same intervention visit.
|
Time to complete the approximately 10-kilometer cycling time trial on an ergometer
|
Twice per visit. First, immediately following the standardized cycling protocol, and second, 4 hours post-exercise during the same intervention visit.
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ITC-2026-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Glycogen Metabolism
-
Duke UniversityKriya TherapeuticsRecruitingGlycogen Storage Disease VI | GLYCOGEN STORAGE DISEASE IXa1 | GLYCOGEN STORAGE DISEASE IXa2 | Glycogen Storage Disease IXB | Glycogen Storage Disease IXC | GSD 9 (All Subtypes) | GSD 6United States
-
Ultragenyx Pharmaceutical IncCompletedGlycogen Storage Disease Type IAUnited States, Brazil, Japan, Spain, Germany, Italy, Netherlands, Canada, Denmark
-
Ultragenyx Pharmaceutical IncCompletedGlycogen Storage Disease Type IANetherlands, United States
-
Manchester Metropolitan UniversityCargill; The University of BathNot yet recruitingHealthy Adult Male | Carbohydrate Metabolism | Hepatic Glycogen Storage
-
University Medical Center GroningenUltragenyx Pharmaceutical IncCompletedGlycogen Storage Disease Type IANetherlands
-
Ultragenyx Pharmaceutical IncRecruitingGlycogen Storage Disease Type IaUnited States, Japan, Germany, Netherlands, Spain, Canada, Denmark, Italy, Brazil
-
University of ManitobaCo-Investigator - Dr. Cheryl Rockman-GreenbergCompletedHypoglycemia | Glycogen Storage Disorder Type 1 | Cornstarch | GlycosadeCanada
-
Ultragenyx Pharmaceutical IncCompletedGlycogen Storage Disease Type IA | Von Gierke's Disease (GSD Type Ia)Netherlands, Spain, United States, Canada
-
Connecticut Children's Medical CenterGlobal Center for Glycogen Storage Disease held at the Jewish Community FoundationRecruiting
-
Beam Therapeutics Inc.RecruitingGlycogen Storage Disease Type IaUnited States
Clinical Trials on Placebo drink
-
Wageningen UniversityMaastricht University Medical Center; Top Institute Food and NutritionCompleted
-
Mayo ClinicCompletedCardiovascular System | Hemodynamics | Energy DrinksUnited States
-
Virginia Polytechnic Institute and State UniversityCompletedCardiovascular Risk FactorUnited States
-
University of California, RiversideA1CantusNot yet recruiting
-
University of the PacificCompletedCardiovascular DiseasesUnited States
-
Maastricht University Medical CenterTop Institute Food and NutritionCompletedMuscle Loss in ElderlyNetherlands
-
University of LimerickCompleted
-
University of LeedsArla FoodsCompletedCognitive Performance (Focus)United Kingdom