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

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

Interventional

Enrollment (Anticipated)

12

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Stockholm, Sweden, 114 86
        • Swedish School of Sports and Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy volunteer
  • 18-45 years old

Exclusion Criteria:

  • Any chronic disease
  • Inability to perform cycling exercise
  • Allergic to anesthesia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
Isothiocyanate rich sprout juice consumption for 1 week
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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 20, 2021

Primary Completion (Actual)

December 1, 2022

Study Completion (Anticipated)

December 5, 2023

Study Registration Dates

First Submitted

September 1, 2021

First Submitted That Met QC Criteria

October 5, 2021

First Posted (Actual)

October 7, 2021

Study Record Updates

Last Update Posted (Estimate)

December 6, 2022

Last Update Submitted That Met QC Criteria

December 5, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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