NCT05070585

Brief 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 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Oct 2021

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 1, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 7, 2021

Completed
13 days until next milestone

Study Start

First participant enrolled

October 20, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 5, 2023

Completed
Last Updated

December 6, 2022

Status Verified

December 1, 2022

Enrollment Period

1.1 years

First QC Date

September 1, 2021

Last Update Submit

December 5, 2022

Conditions

Keywords

IsothiocyanatesBlood lactateGlucose regulationNrf2

Outcome Measures

Primary Outcomes (3)

  • Blood lactate

    Changes in blood lactate during exercise

    Acute during sub maximal exercise

  • Nrf2 activation

    Increased Nrf2 protein in human skeletal muscle

    Acute after 1 week of supplementation

  • Glucose regulation

    Improved continuous glucose control

    Throughout 1 week of supplementation

Secondary Outcomes (2)

  • Glucose tolerance test

    120 minutes

  • Clinic blood pressure

    Acute after 1 week of supplementation

Study Arms (2)

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.

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.

Dietary Supplement: Placebo Juice

Interventions

Isothiocyanate rich sproutsDIETARY_SUPPLEMENT

Isothiocyanate rich sprout juice consumption for 1 week

Isothiocyanate Rich Juice
Placebo JuiceDIETARY_SUPPLEMENT

Sprout juice devoid of isothiocyanates for 1 week

Placebo Juice

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy volunteer
  • years old

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Swedish School of Sports and Health Sciences

Stockholm, 114 86, Sweden

Location

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
The subjects will receive a sprout juice or a placebo juice made of alfalfa sprouts.
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: Randomized, placebo controlled, cross-over study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 1, 2021

First Posted

October 7, 2021

Study Start

October 20, 2021

Primary Completion

December 1, 2022

Study Completion

December 5, 2023

Last Updated

December 6, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations