The PROtective Effect of SulforAphaNe on Chronic Low-grade Inflammation in Healthy Participants
Condition: Inflammation
MeSH terms: Inflammation
Study type: Interventional

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.
    


Intervention name(s): BroccoCress; Affilla Cress
Intervention type(s): Other; Other
Intervention description(s): BroccoCress® is a brand name for an edible plant, broccoli sprouts. BroccoCress® is a product within the group of vegetable sprouts.; Pea sprouts commercially available as Affilla Cress® will be used as placebo in this study since these sprouts do not contain Glucoraphanin/Sulforaphane.
Other intervention name(s): Sulforaphane; Pea sprouts
Intervention MeSH terms: Sulforaphane
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Sulforaphane Inflammation Challenge BroccoCress; Inflammation; Challenge; BroccoCress