Metabolic DisturbancePhase 1/2IMHNCT05070585
Isothiocyanates and Metabolic Health
A Phase 1/2 study testing Isothiocyanate rich sprouts in people with Metabolic Disturbance, run by The Swedish School of Sport and Health Sciences at 1 site in Sweden.
Trial summary
Many sprouts, for example broccoli sprouts, contain substances that have shown to have protective effects, both against oxidative stress and against carcinogenic substances. In this study we will investigate the activation of the body's antioxidant defense system and effect on blood lactate and glucose after 1 week of… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Disturbance
- What is being tested?
- Isothiocyanate rich sprouts
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteSweden
- Study dates
- 20 Oct 2021to 5 Dec 2023
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteer
- 18-45 years old
Who cannot join
- Any chronic disease
- Inability to perform cycling exercise
- Allergic to anesthesia
Trial locations and contacts
1 site in 1 country.
About this study
Many sprouts, for example broccoli sprouts, contain substances that have shown to have protective effects, both against oxidative stress and against carcinogenic substances.
In this study we will investigate the activation of the body's antioxidant defense system and effect on blood lactate and glucose after 1 week of isothiocyanate rich sprout supplementation. The subjects will perform maximal and submaximal work test, blood sampling, muscle biopsies and blood pressure monitoring post supplementation. We hypothesize that 1 week of supplementation of isothiocyanate rich sprouts alters blood lactate and glucose metabolism and activates the body's antioxidant defense system.
Read the detailed description
Many sprouts, for example broccoli sprouts, contain high levels of glucosinolates, which can be converted to the bioactive substances isothiocyanates. This conversion is assisted by another plant enzyme, myrosinase, which is released when the plant is mechanically processed. It is believed that this reaction is part of the plant's natural defense against pest insects and other animals that attack the plant in the early developmental stage. In cell and animal studies supplementation with isothiocyanates has been shown to induce the protein Nrf2 which is a so-called "Master regulator" of the body's antioxidant defenses and activates more than 200 genes that together provide a strong protection against oxidative and mutagenic stress.
In this study we will investigate Nrf2 activation in human skeletal muscle and effect on lactate-, glucose metabolism after 1 week of isothiocyanate rich sprout supplementation. The study is a double-blinded, randomized, placebo controlled, cross-over study with 4 weeks wash-out between the interventions. We will perform maximal- and submaximal work test and monitor blood glucose and lactate during the tests. Also, in the post intervention phases we will perform muscle biopsies, glucose tolerance tests and monitor blood pressure.
The hypothesis is that 1 week of isothiocyanate rich sprout supplementation activates Nrf2 in human skeletal muscle and alters blood lactate and glucose metabolism in rest and during exercise.
- Conditions
- Metabolic Disturbance
- Being tested
- Isothiocyanate rich sprouts, Placebo Juice
- Keywords
- Isothiocyanates, Blood lactate, Glucose regulation, Nrf2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isothiocyanate rich sproutsDietary supplement
Isothiocyanate rich sprout juice consumption for 1 week
Placebo JuiceDietary supplement
Sprout juice devoid of isothiocyanates for 1 week
| Study group | Role | What they receive |
|---|---|---|
| Isothiocyanate Rich Juice | Experimental | The juices will contain 37,5g isothiocyanate rich sprouts and be delivered frozen to the subjects. The subjects will be instructed to consume two juices per day. Receives: Dietary Supplement: Isothiocyanate rich sprouts |
| Placebo Juice | Placebo comparator | The juices will contain 37,5g alfalfa sprouts and be delivered frozen to the subjects. The subjects will be instructed to consume two juices per day. Receives: Dietary Supplement: Placebo Juice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood lactate
Changes in blood lactate during exercise
Measured: Acute during sub maximal exercise
Nrf2 activation
Increased Nrf2 protein in human skeletal muscle
Measured: Acute after 1 week of supplementation
Glucose regulation
Improved continuous glucose control
Measured: Throughout 1 week of supplementation
Secondary outcomes (2)
Glucose tolerance test
Improved glucose regulation in rest
Measured: 120 minutes
Clinic blood pressure
Blood pressure regulation
Measured: Acute after 1 week of supplementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2021
- Study start20 Oct 2021
- Primary completion1 Dec 2022
- Study completion5 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic DisturbanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized, placebo controlled, cross-over study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Swedish School of Sport and Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05070585
- Sponsor's protocol ID
- SwedishSchoolSport
- Acronym
- IMH
- Status last verified
- Dec 2022
- First submitted
- 1 Sep 2021
- Last updated
- 6 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Isothiocyanates and Metabolic Health
- ClinicalTrials.gov ID
- NCT05070585
- Acronym / sponsor ID
- IMH / SwedishSchoolSport
- Conditions
- Metabolic Disturbance
- Keywords
- Isothiocyanates, Blood lactate, Glucose regulation, Nrf2
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- The Swedish School of Sport and Health SciencesUniversity, hospital or other
- Study start
- 20 Oct 2021 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 5 Dec 2023 (estimated)
- First posted
- 7 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Many sprouts, for example broccoli sprouts, contain substances that have shown to have protective effects, both against oxidative stress and against carcinogenic substances.
In this study we will investigate the activation of the body's antioxidant defense system and effect on blood lactate and glucose after 1 week of isothiocyanate rich sprout supplementation. The subjects will perform maximal and submaximal work test, blood sampling, muscle biopsies and blood pressure monitoring post supplementation. We hypothesize that 1 week of supplementation of isothiocyanate rich sprouts alters blood lactate and glucose metabolism and activates the body's antioxidant defense system.
Detailed description
Many sprouts, for example broccoli sprouts, contain high levels of glucosinolates, which can be converted to the bioactive substances isothiocyanates. This conversion is assisted by another plant enzyme, myrosinase, which is released when the plant is mechanically processed. It is believed that this reaction is part of the plant's natural defense against pest insects and other animals that attack the plant in the early developmental stage. In cell and animal studies supplementation with isothiocyanates has been shown to induce the protein Nrf2 which is a so-called "Master regulator" of the body's antioxidant defenses and activates more than 200 genes that together provide a strong protection against oxidative and mutagenic stress.
In this study we will investigate Nrf2 activation in human skeletal muscle and effect on lactate-, glucose metabolism after 1 week of isothiocyanate rich sprout supplementation. The study is a double-blinded, randomized, placebo controlled, cross-over study with 4 weeks wash-out between the interventions. We will perform maximal- and submaximal work test and monitor blood glucose and lactate during the tests. Also, in the post intervention phases we will perform muscle biopsies, glucose tolerance tests and monitor blood pressure.
The hypothesis is that 1 week of isothiocyanate rich sprout supplementation activates Nrf2 in human skeletal muscle and alters blood lactate and glucose metabolism in rest and during exercise.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomized, placebo controlled, cross-over study
| Arm | Type | Receives |
|---|---|---|
| Isothiocyanate Rich Juice | Experimental | Dietary Supplement: Isothiocyanate rich sproutsThe juices will contain 37,5g isothiocyanate rich sprouts and be delivered frozen to the subjects. The subjects will be instructed to consume two juices per day. |
| Placebo Juice | Placebo comparator | Dietary Supplement: Placebo JuiceThe juices will contain 37,5g alfalfa sprouts and be delivered frozen to the subjects. The subjects will be instructed to consume two juices per day. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy volunteer
- 18-45 years old
Key exclusion criteria (3 listed)
- Any chronic disease
- Inability to perform cycling exercise
- Allergic to anesthesia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Isothiocyanate rich sproutsIsothiocyanate rich sprout juice consumption for 1 week | Dietary supplement | Isothiocyanate Rich Juice |
| Placebo JuiceSprout juice devoid of isothiocyanates for 1 week | Dietary supplement | Placebo Juice |
Primary outcome
Blood lactate
Time frame: Acute during sub maximal exercise
Changes in blood lactate during exercise
Nrf2 activation
Time frame: Acute after 1 week of supplementation
Increased Nrf2 protein in human skeletal muscle
Glucose regulation
Time frame: Throughout 1 week of supplementation
Improved continuous glucose control
2 secondary outcomes
Glucose tolerance test
Time frame: 120 minutes
Clinic blood pressure
Time frame: Acute after 1 week of supplementation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2022.
- Individual participant dataSharing planned: No
Related trials for Metabolic Disturbance
Enrolling by invitation
SHADES Mechanistic Trial
Insomnia, Insomnia Chronic
Active, not recruiting
Effects of Multi-day Interruptions in Sitting on Type 2 Diabetes-relevant Outcomes in Children
Sedentary Behavior, Affect
RecruitingObservational study
Pro- and Anti-inflammatory Cytokines in PCOS
Reproductive Age, PCOS (Polycystic Ovary Syndrome)
Recruiting
Improved Muscle Metabolism by Combination of Muscle Activation and Protein Substitution ( IMEMPRO )
ICU Acquired Weakness, Muscle Atrophy
Recruiting
Multiple Risk Factor Intervention Trial in Breast Cancer Survivors
Metabolic Disturbance, Sedentary Behavior
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Isothiocyanate rich sprouts in people with Metabolic Disturbance, run by The Swedish School of Sport and Health Sciences at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood lactate (time frame: Acute during sub maximal exercise). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2022; AzTrials last refreshed its copy on 6 Nov 2026.