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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BroccoCress | Other | BroccoCress® is a brand name for an edible plant, broccoli sprouts. BroccoCress® is a product within the group of vegetable sprouts. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change of endothelial activation. | Change of plasma concentrations of sVCAM (ng/mL) and sICAM (ng/mL) | Day 1, Day 8±3 |
| Measure | Description | Time Frame |
|---|---|---|
| Change of the systemic low-grade inflammation score (SIS) | The systemic low-grade inflammation score (SIS). The SIS score will be constructed from:
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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Campus Venlo, Maastricht University | Venlo | Limburg | 5911 BV | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38089924 | Derived | 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. | |
| 37485383 | Derived |
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| ID | Term |
|---|---|
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C016766 | sulforaphane |
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| Affilla Cress | Other | Pea sprouts commercially available as Affilla Cress® will be used as placebo in this study since these sprouts do not contain Glucoraphanin/Sulforaphane. |
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| 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. | 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 | Day 1, Day 8±3 |
| Change of Urinary 11dhTxB2. | Quantification of urinary 11dhTxB2 (μg) by ELISA | 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. | Day 1, Day 8±3 |
| 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. |