Clinical trial NCT05146804: The PROtective Effect of SulforAphaNe on Chronic Low-grade Inflammation in Healthy Participants
Official title: ''The PROtective Effect of SulforAphaNe on Chronic Low-grade Inflammation in Healthy Participants'': The PRO SANI Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inflammation
Keywords: Sulforaphane Inflammation Challenge BroccoCress
Inflammation
Challenge
BroccoCress
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2021-12-07
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)
* 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

Primary outcomes:
measure: Change of endothelial activation.
timeFrame: Day 1, Day 8±3
Secondary outcomes:
measure: Change of the systemic low-grade inflammation score (SIS)
timeFrame: Day 1, Day 8±3
measure: Change of NF-κB activity and Nrf2 activity.
timeFrame: Day 1, Day 8±3
measure: 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).
timeFrame: Day 1, Day 8±3
measure: Change of Urinary 11dhTxB2.
timeFrame: Day 1, Day 8±3
measure: Change of HRV
timeFrame: Day 1, Day 8±3
Other outcomes:
Locations:
city: Venlo
country: Netherlands
facility: Campus Venlo, Maastricht University
state: Limburg
Study officials:
References: