- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05070585
Isothiocyanates and Metabolic Health (IMH)
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
-
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Stockholm, Sweden, 114 86
- Swedish School of Sports and Health Sciences
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Healthy volunteer
- 18-45 years old
Exclusion Criteria:
- Any chronic disease
- Inability to perform cycling exercise
- Allergic to anesthesia
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Isothiocyanate Rich Juice
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.
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Isothiocyanate rich sprout juice consumption for 1 week
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Placebo Comparator: Placebo Juice
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.
|
Sprout juice devoid of isothiocyanates for 1 week
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Blood lactate
Time Frame: Acute during sub maximal exercise
|
Changes in blood lactate during exercise
|
Acute during sub maximal exercise
|
Nrf2 activation
Time Frame: Acute after 1 week of supplementation
|
Increased Nrf2 protein in human skeletal muscle
|
Acute after 1 week of supplementation
|
Glucose regulation
Time Frame: Throughout 1 week of supplementation
|
Improved continuous glucose control
|
Throughout 1 week of supplementation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Glucose tolerance test
Time Frame: 120 minutes
|
Improved glucose regulation in rest
|
120 minutes
|
Clinic blood pressure
Time Frame: Acute after 1 week of supplementation
|
Blood pressure regulation
|
Acute after 1 week of supplementation
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SwedishSchoolSport
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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.
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