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*The PROtective effect of SulforAphaNe on chronic low-grade Inflammation in healthy participants**: The PRO SANI study

*The PROtective effect of SulforAphaNe on chronic low-grade Inflammation in healthy participants**: The PRO SANI study - The effects of sulforaphane on diet-induced inflammation

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON51215
Enrollment
12
Registered
2021-10-05
Start date
2022-11-24
Completion date
Unknown
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Laaggradige chronische ontstekingen chronic inflammation Low-grade inflammation

Interventions

The participants will be randomized into two groups and receive either approximately 16 grams of BroccoCress® or placebo (Affilla Cress®, 16 grams) 90 minutes prior to the oral challenge test at the

Sponsors

Universiteit Maastricht
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: 1. Signed informed consent form (ICF) prior to initiation of any study related procedures 2. Male or female volunteer 3. Age 18-50 years 4. BMI between 18.5-30 kg/m2 5. 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 6. Constant eating habits during at least 3 months prior to inclusion into the study

Exclusion criteria

Exclusion criteria: 1. Having a history of medical or surgical events that may significantly affect the study outcomes and inflammatory response 2. 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) 3. Regular intake of medication that may affect inflammatory response from 2 weeks before screening until the end of the study, including NSAIDs such as Ibuprofen, Naproxen, Diclofenac. Participants are allowed to use oral contraceptives before and during the study. 4. Psychotic, addictive or other mental disorders limiting the ability to provide informed consent or to comply with the study requirements 5. 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). 6. 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 certain polysaccharides. 7. Excessive alcohol consumption (>= 28 consumptions approx. 250 g alcohol per week) 8. Viral or bacterial infection requiring use of antibiotics, laxatives and anti-diarrheal drugs within 4 weeks prior to inclusion into this study 9. Pregnancy and/or breastfeeding 10. Reported slimming or medically prescribed diet 11. Vegetarian or vegan lifestyle

Design outcomes

Primary

MeasureTime frame
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.

Secondary

MeasureTime frame
The secondary objectives of the study are to evaluate the effects of sulforaphane in healthy participants subjected to the *PhenFlex* challenge on: - The systemic low-grade inflammation score (SIS). The SIS score will be constructed from: o Biomarkers that represent metabolic tissue inflammation (IL-1 b, IL-6, and tumor necrosis factor alpha [TNF-a]) o 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]) o Biomarkers of inflammation resolution (IL-10, adiponectin) o Biomarkers of overall inflammation (CRP and IL-12 p70). The SIS will be generated by 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. - To assess the bioavailability of glucoraphanin and sulforaphane from broccoli sprouts, urine concentrations of SFN and metabolites will be determined; SFN-glutathione, SFN-cysteine-glycine, SFN-cysteine, and SFN-N-acetylcysteine (SFN-NAC). - NF-*B activity and Nrf2 activity. - Urinary 11dhTxB2 (AspirinWorks®). - Heart Rate Variability; to examine if the PhenFlex challenge and intervention can induce changes in heart rate variability and to explore their relationship with changes in inflammatory biomarkers.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)