The PROtective Effect of SulforAphaNe on Chronic Low-grade Inflammation in Healthy Participants

NCT ID: NCT05146804

Last Updated: 2022-04-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-11
• Study Completion Date: 2022-02-03

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.

Conditions

Inflammation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

BroccoCress/Affilla Cress

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.

Group Type: OTHER

BroccoCress

Intervention Type: OTHER

BroccoCress® is a brand name for an edible plant, broccoli sprouts. BroccoCress® is a product within the group of vegetable sprouts.

Affilla Cress

Intervention Type: OTHER

Pea sprouts commercially available as Affilla Cress® will be used as placebo in this study since these sprouts do not contain Glucoraphanin/Sulforaphane.

Affilla Cress/Broccocress

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.

Group Type: OTHER

BroccoCress

Intervention Type: OTHER

BroccoCress® is a brand name for an edible plant, broccoli sprouts. BroccoCress® is a product within the group of vegetable sprouts.

Affilla Cress

Intervention Type: OTHER

Pea sprouts commercially available as Affilla Cress® will be used as placebo in this study since these sprouts do not contain Glucoraphanin/Sulforaphane.

Interventions

BroccoCress

BroccoCress® is a brand name for an edible plant, broccoli sprouts. BroccoCress® is a product within the group of vegetable sprouts.

Intervention Type: OTHER

Affilla Cress

Pea sprouts commercially available as Affilla Cress® will be used as placebo in this study since these sprouts do not contain Glucoraphanin/Sulforaphane.

Intervention Type: OTHER

Other Intervention Names

Sulforaphane; Pea sprouts

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Maastricht University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Campus Venlo, Maastricht University

Venlo, Limburg, Netherlands

Countries

Netherlands

References

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.

Reference Type: DERIVED

PMID: 38089924 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 37485383 (View on PubMed)

Other Identifiers

PRO SANI NL77272.068.21

Identifier Type: -

Identifier Source: org_study_id