NCT05146804

Brief Summary

Rationale: Most non-communicable diseases are partially affected by low-grade chronic inflammation. Research has shown that sulforaphane, an ingredient found in abundance in broccoli, shows promise as a potent anti-inflammatory substance. However, its potential in the settings of the caloric-induced inflammatory response has not been tested. Objective: In the present study, the investigators aim to assess the efficacy of sulforaphane on biomarkers of inflammation and other markers of phenotypic flexibility in healthy participants subjected to the standardized 'PhenFlex' challenge. Study design: Double-blind, crossover, randomized, placebo-controlled, intervention study. Study population: Healthy human volunteers (18-50 years old) Intervention: Participants will receive 16 grams (intervention) of broccoli sprouts (BroccoCress®) and 16 grams of Affilla Cress® (placebo) on different occasions in randomized order. Main study parameters/endpoints: The main endpoint of the present study is to demonstrate that sulforaphane can influence endothelial activation measured as changes in plasma concentrations of sVCAM and sICAM in a caloric challenge test in healthy participants. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Use of BroccoCress® in human subjects has not been related to adverse effects, except of the individuals who show individual intolerance to cruciferous vegetables. Those individuals will not be permitted into the study. The 'PhenFlex', a high-fat, high-glucose, high-calorie drink, is used for the caloric load. The PhenFlex has been used in three studies before, with no side effects reported after consumption. Sampling of venous blood can potentially cause complications (haematoma formation, fainting, etc). The procedures involved in this study will include an interview, assessment of vital signs, completion of the study related questionnaires and collection of blood and urine samples. Volunteers will receive an unsubstantial financial reward for the participation in this study. The results will provide information on whether the intake of cruciferous vegetables rich in sulforaphane can increase resilience to excessive inflammatory stimuli associated with caloric overload and potentially provide evidence on the role of dietary ingredients in combating chronic low-grade inflammation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 11, 2021

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

November 15, 2021

Completed
22 days until next milestone

First Posted

Study publicly available on registry

December 7, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 3, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 3, 2022

Completed
Last Updated

April 13, 2022

Status Verified

April 1, 2022

Enrollment Period

3 months

First QC Date

November 15, 2021

Last Update Submit

April 12, 2022

Conditions

Inflammation

Keywords

Sulforaphane Inflammation Challenge BroccoCressInflammationChallengeBroccoCress

Outcome Measures

Primary Outcomes (1)

  • Change of endothelial activation.

    Change of plasma concentrations of sVCAM (ng/mL) and sICAM (ng/mL)

    Day 1, Day 8±3

Secondary Outcomes (5)

  • Change of the systemic low-grade inflammation score (SIS)

    Day 1, Day 8±3

  • Change of NF-κB activity and Nrf2 activity.

    Day 1, Day 8±3

  • Change of urinary concentrations (μmol) of SFN and metabolites will be determined; SFN-glutathione, SFN-cysteine-glycine, SFN-cysteine, and SFN-N-acetylcysteine (SFN-NAC).

    Day 1, Day 8±3

  • Change of Urinary 11dhTxB2.

    Day 1, Day 8±3

  • Change of HRV

    Day 1, Day 8±3

Study Arms (2)

BroccoCress/Affilla Cress

OTHER

Potential participants will be screened after showing their interest to participate to the study. When they are considered eligible to participate (after a phone call with the executing researcher), participants will be randomized into one of the two groups in this study: either consuming the broccoli sprouts on day one (visit 1) and the placebo product in the second visit, or the other way around (placebo product on day 1 and the intervention during the second visit). Both days, participants will consume the PhenFlex, the challenge product with the high caloric load. This will allow for analyzing the effectiveness of the intervention on different biomarkers of chronic, low-grade inflammation, with the main objective being on endothelial activation.

Other: BroccoCressOther: Affilla Cress

Affilla Cress/Broccocress

OTHER

Potential participants will be screened after showing their interest to participate to the study. When they are considered eligible to participate (after a phone call with the executing researcher), participants will be randomized into one of the two groups in this study: either consuming the broccoli sprouts on day one (visit 1) and the placebo product in the second visit, or the other way around (placebo product on day 1 and the intervention during the second visit). Both days, participants will consume the PhenFlex, the challenge product with the high caloric load. This will allow for analyzing the effectiveness of the intervention on different biomarkers of chronic, low-grade inflammation, with the main objective being on endothelial activation.

Other: BroccoCressOther: Affilla Cress

Interventions

BroccoCressOTHER

BroccoCress® is a brand name for an edible plant, broccoli sprouts. BroccoCress® is a product within the group of vegetable sprouts.

Also known as: Sulforaphane
Affilla Cress/BroccocressBroccoCress/Affilla Cress
Affilla CressOTHER

Pea sprouts commercially available as Affilla Cress® will be used as placebo in this study since these sprouts do not contain Glucoraphanin/Sulforaphane.

Also known as: Pea sprouts
Affilla Cress/BroccocressBroccoCress/Affilla Cress

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Signed informed consent form (ICF) prior to initiation of any study related procedures
  • Male or female volunteer
  • Age 18-50 years
  • BMI between 18.5-30 kg/m2

You may not qualify if:

  • Having a history of medical or surgical events that may significantly affect the study outcomes and inflammatory response. More specifically, the previous diagnosis of an inflammatory condition or disease or a history of hypothyroidism, chronic kidney or/and liver disorders, coronary artery disease, malignant hypertension, seizures.
  • Involved in intensive sports activities more than 4 times a week or at top sport level (e.g. playing football, tennis, running, race-cycling, swimming)
  • Regular intake of medication. More specific, medication that may affect inflammatory response including NSAIDs such as Ibuprofen, Naproxen, Diclofenac is not allowed from 2 weeks before screening until the end of the study. Participants are allowed to use oral contraceptives before and during the study.
  • Psychotic, addictive or other mental disorders limiting the ability to provide informed consent or to comply with the study requirements
  • Aversion, intolerance or allergy to cruciferous vegetables (e.g. kale consumption; bloating) or ingredients of the PhenFlex drink (palm olein, dextrose, protein supplement, vanilla aroma).
  • Pregnancy and/or breastfeeding
  • Reported slimming or medically prescribed diet
  • Vegetarian or vegan lifestyle

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Campus Venlo, Maastricht University

Venlo, Limburg, 5911 BV, Netherlands

Location

Related Publications (2)

  • van Steenwijk HP, Vinken A, van Osch FHM, Peppelenbos H, Troost FJ, Bast A, Semen KO, de Boer A. Sulforaphane as a potential modifier of calorie-induced inflammation: a double-blind, placebo-controlled, crossover trial. Front Nutr. 2023 Nov 28;10:1245355. doi: 10.3389/fnut.2023.1245355. eCollection 2023.

    PMID: 38089924DERIVED

  • van Steenwijk HP, Winter E, Knaven E, Brouwers JF, van Baardwijk M, van Dalum JB, Luijendijk TJC, van Osch FHM, Troost FJ, Bast A, Semen KO, de Boer A. The beneficial effect of sulforaphane on platelet responsiveness during caloric load: a single-intake, double-blind, placebo-controlled, crossover trial in healthy participants. Front Nutr. 2023 Jul 6;10:1204561. doi: 10.3389/fnut.2023.1204561. eCollection 2023.

    PMID: 37485383DERIVED

MeSH Terms

Conditions

Inflammation

Interventions

sulforaphane

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 15, 2021

First Posted

December 7, 2021

Study Start

November 11, 2021

Primary Completion

February 3, 2022

Study Completion

February 3, 2022

Last Updated

April 13, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)