InflammationPRO SANINCT05146804
The PROtective Effect of SulforAphaNe on Chronic Low-grade Inflammation in Healthy Participants
A study testing BroccoCress and Affilla Cress in people with Inflammation, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflammation
- What is being tested?
- BroccoCress and Affilla Cress
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteNetherlands
- Study dates
- 11 Nov 2021to 3 Feb 2022
- Phase
- Interventional
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
- Stable weight and no intention to lose weight until completion of the study; no reported weight loss or weight gain of ≥ 5 kg 3 months prior to inclusion into this study
- Constant eating habits during at least 3 months prior to inclusion into the study
Who cannot join
- 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).
- Use of dietary supplements with potential effects on antioxidant or inflammatory status within 4 weeks prior to inclusion into this study. Examples of dietary supplements not allowed in the study include supplements containing flavonoids, glucosinolates, carotenoids, ergothioneine, polyacetylenes and polysaccharides. - Excessive alcohol consumption (≥ 28 consumptions approx. 250 g alcohol per week)
Show all 10Show fewer
- Viral or bacterial infection requiring use of antibiotics, laxatives and anti-diarrheal drugs within 4 weeks prior to inclusion into this study
- Pregnancy and/or breastfeeding
- Reported slimming or medically prescribed diet
- Vegetarian or vegan lifestyle
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Campus Venlo, Maastricht University
Venlo, Limburg, 5911 BV
About this study
Official title: ''The PROtective Effect of SulforAphaNe on Chronic Low-grade Inflammation in Healthy Participants'': The PRO SANI Study
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.
Read more
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.
- Conditions
- Inflammation
- Being tested
- BroccoCress, Affilla Cress
- Keywords
- Sulforaphane Inflammation Challenge BroccoCress, Inflammation, Challenge, BroccoCress
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BroccoCressOther
Also called Sulforaphane
BroccoCress® is a brand name for an edible plant, broccoli sprouts. BroccoCress® is a product within the group of vegetable sprouts.
Affilla CressOther
Also called Pea sprouts
Pea sprouts commercially available as Affilla Cress® will be used as placebo in this study since these sprouts do not contain Glucoraphanin/Sulforaphane.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: BroccoCress; Other: 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. Receives: Other: BroccoCress; Other: Affilla Cress |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of endothelial activation.
Change of plasma concentrations of sVCAM (ng/mL) and sICAM (ng/mL)
Measured: Day 1, Day 8±3
Secondary outcomes (5)
Change of the systemic low-grade inflammation score (SIS)
The systemic low-grade inflammation score (SIS). The SIS score will be constructed from:
- Biomarkers that represent metabolic tissue inflammation (IL-1b,IL-6,and tumor necrosis factor alpha [TNF-a])
- Biomarkers of immune cell recruitment (C-C motif ligand-2[CCL-2]),IL-8, soluble intercellular adhesion molecule-1 [sICAM-1], soluble vascular cell adhesion molecule-1 [sVCAM-1])
- Biomarkers of inflammation resolution(IL-10, adiponectin)
- Biomarkers of overall inflammation (CRPandIL-12p70).
A SIS will be generated summing the z-score log-transformed inflammatory biomarkers plasma concentration (CRP, IL-1 b, IL-6, IL-8, IL-12 p70, TNF-a, CCL-2, sICAM-1, and sVCAM-1). The Z-score log-transformed plasma adiponectin and IL-10 levels will be subtracted from SIS because of their well-known anti-inflammatory functions.
Measured: Day 1, Day 8±3
Change of NF-κB activity and Nrf2 activity.
NF-KB activity and Nrf2 activity will be measured by ELISA to assess pathway activation.
Detection principle of Human Nuclear Factor Kappa B ( NF-κB)ELISA kit This experiment use double-sandwich elisa technique and the ELISA Kit provided is typical.
The Human NRF2 ELISA Kit is a solid-phase sandwich Enzyme-Linked Immunosorbent Assay (ELISA) designed to detect and quantify the level of human NRF2 in cell culture supernatants, plasma, and serum.
Measured: 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).
Estimation of bioavailability
Measured: Day 1, Day 8±3
Change of Urinary 11dhTxB2.
Quantification of urinary 11dhTxB2 (μg) by ELISA
Measured: Day 1, Day 8±3
Change of HRV
HRV will be assessed in short term (5 min) ECG recording obtained in supine position and analysed as recommended by current standards (ESC / NASPE, 1996). Total power (TP), high-frequency power (HF), low frequency power (LF), and very low- frequency power (VLF) will be derived from the spectral analysis. Also, the following time domain indices will be assessed: standard deviation of normal RR intervals (SDNN); square root of the mean squared differences of successive RR interval, (RMSSD); percentage of differences between adjacent normal RR intervals exceeding 50 milliseconds (pNN50). The recordings of ECG will be performed 4 times: (i) before administration of investigational product; (ii) before administration of PhenFlex; (iii) 30 min after administration of PhenFlex; (iv) 2 hours administration of PhenFlex.
Measured: Day 1, Day 8±3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2021
- Study start11 Nov 2021
- Primary completion3 Feb 2022
- Study completion3 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for InflammationStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05146804
- Sponsor's protocol ID
- PRO SANI NL77272.068.21
- Acronym
- PRO SANI
- Status last verified
- Apr 2022
- First submitted
- 15 Nov 2021
- Last updated
- 13 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38089924van 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.
PubMed 37485383
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ''The PROtective Effect of SulforAphaNe on Chronic Low-grade Inflammation in Healthy Participants'': The PRO SANI Study
- ClinicalTrials.gov ID
- NCT05146804
- Acronym / sponsor ID
- PRO SANI / PRO SANI NL77272.068.21
- Conditions
- Inflammation
- Keywords
- Sulforaphane Inflammation Challenge BroccoCress, Inflammation, Challenge, BroccoCress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- 11 Nov 2021 (actual)
- Primary completion
- 3 Feb 2022 (actual)
- Study completion
- 3 Feb 2022 (actual)
- First posted
- 7 Dec 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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BroccoCress/Affilla Cress | Other | Other: BroccoCress, Other: Affilla CressPotential 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. |
| Affilla Cress/Broccocress | Other | Other: BroccoCress, Other: Affilla CressPotential 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
- Stable weight and no intention to lose weight until completion of the study; no reported weight loss or weight gain of ≥ 5 kg 3 months prior to inclusion into this study
Key exclusion criteria (10 listed)
- 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).
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 |
|---|---|---|
| BroccoCressAlso: SulforaphaneBroccoCress® is a brand name for an edible plant, broccoli sprouts. BroccoCress® is a product within the group of vegetable sprouts. | Other | Affilla Cress/Broccocress, BroccoCress/Affilla Cress |
| Affilla CressAlso: Pea sproutsPea sprouts commercially available as Affilla Cress® will be used as placebo in this study since these sprouts do not contain Glucoraphanin/Sulforaphane. | Other | Affilla Cress/Broccocress, BroccoCress/Affilla Cress |
Primary outcome
Change of endothelial activation.
Time frame: Day 1, Day 8±3
Change of plasma concentrations of sVCAM (ng/mL) and sICAM (ng/mL)
5 secondary outcomes
Change of the systemic low-grade inflammation score (SIS)
Time frame: Day 1, Day 8±3
Change of NF-κB activity and Nrf2 activity.
Time frame: 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).
Time frame: Day 1, Day 8±3
Change of Urinary 11dhTxB2.
Time frame: Day 1, Day 8±3
Change of HRV
Time frame: Day 1, Day 8±3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2022.
- Derived from this study: PubMed 38089924van 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.
- Derived from this study: PubMed 37485383van 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.
- Individual participant dataSharing planned: No
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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 study testing BroccoCress and Affilla Cress in people with Inflammation, run by Maastricht University Medical Center at 1 site in Netherlands.
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 6 inclusion and 10 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: finished, as of the sponsor's last update on 13 Apr 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 Netherlands. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change of endothelial activation. (time frame: Day 1, Day 8±3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05146804, which also lists 2 linked publications.
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 13 Apr 2022.