The aim of this research is to find out whether eating Broccocress®, a sprout vegetable rich in the substance sulforaphane, can counteract inflammation caused by, among other things, unhealthy food. More precisely, we are investigating whether…
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Source
Brief title
Condition
- Other condition
- Lifestyle issues
Synonym
Health condition
Laaggradige chronische ontstekingen
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
The concept of health has changed in recent years: in addition to medicine and
pharmacology, there is an increasing interest in lifestyle, in which nutrition
plays a central role. Fruits and vegetables seem to have a particularly
positive effect on nutritional status and in reducing the risk of lifestyle
diseases, such as type II diabetes and cardiovascular disease. Research has
shown that the onset and progression of these diseases is in part related to or
influenced by inflammation. From the concept that health is defined by the
ability to adapt adequately to everyday challenges, so-called "challenges" have
recently been designed to better understand people's health status. The work
resulted in the standardized so-called "PhenFlex" oral challenge test, composed
of 75 g glucose, 60 g palm olein (36.6% monounsaturated fatty acids, 48.8%
saturated fatty acids, 9.1% polyunsaturated fatty acids) and 20 g protein,
which is drunk to better map the health status of 'healthy' people.
With this research we want to investigate which substances in fruit and
vegetables can reduce inflammation and thus have a health-promoting effect.
Cruciferous vegetables such as broccoli, Brussels sprouts and cabbage are rich
sources of sulforaphane, a compound that appears to have health-promoting
effects. Because sulforaphane has recently gained a lot of interest due to its
potential health effects, companies are investing in the development of
vegetables with high sulforaphane concentrations.
Broccocress® is a brand name of an edible sprout vegetable that contains a high
sulforaphane concentration compared to broccoli, for example. Studies have
shown that broccoli sprouts improved "biomarkers" of type 2 diabetes, including
reductions in fasting blood glucose levels and stabilization of the insulin
response in type 2 diabetic patients, especially obese patients.
Study objective
The aim of this research is to find out whether eating Broccocress®, a sprout
vegetable rich in the substance sulforaphane, can counteract inflammation
caused by, among other things, unhealthy food. More precisely, we are
investigating whether sulforaphane can reduce the formation of inflammation in
the body in healthy subjects who consume a simulated "vigorous" unhealthy meal,
in the form of PhenFlex "challenge". By consuming the PhenFlex within five
minutes, the body responds to this challenge by increasing the content of
substances that indicate inflammation. We are investigating whether
sulforaphane can reduce the elevation of these substances, which indirectly
indicates a protective effect against inflammation. We compare the effect of
BroccoCress with the effect of Affilla Cress, a sprout vegetable without
sulforaphane. Affilla Cress is used in this study as a non-active substance or
placebo.
Study design
Double-blind, crossover, randomized, placebo-controlled study
Intervention
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 first visit. At the second
visit, participants consume the intervention or placebo serving prior to the
oral challenge test, or vice versa, depending on randomization.
Study burden and risks
The risk associated with participation in this study will be related to intake
of BroccoCress®, Affilla Cress®, the *PhenFlex* challenge and possible
complications during blood collection. Oral consumption of BroccoCress® and
Affilla Cress® is generally well tolerated and has not been associated with
significant side effects, other than allergic reactions to Brassicacea species.
Allergies to Brassicacea species are rare, and cruciferous plants are
considered safe for human consumption. At the same time, cruciferous plants may
increase resilience to excessive inflammatory stimuli associated with poor
nutrition due to its anti-inflammatory effects. The *PhenFlex* challenge test,
a high-fat, high-glucose, high-caloric drink, has been applied in three
studies. No side effects were reported after consumption of the PhenFlex
challenge in a total of 131 participants. Venipuncture is the most common
procedure performed in health care settings. However, possible complications
during blood collection can occur. Complications that can arise from
venipuncture include haematoma formation, nerve damage, pain,
haemaconcentration, extravasation, iatrogenic anaemia, arterial puncture,
petechiae, allergies, fear and phobia, infection, syncope and fainting,
excessive bleeding, edema and thrombus. For the safety of the participants, we
choose to only draw blood at times when we know from the literature that the
PhenFlex challenge has an effect on inflammatory biomarkers.
Nassaustraat 36
Venlo 5911 BV
NL
Nassaustraat 36
Venlo 5911 BV
NL
Listed location countries
Age
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
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL77272.068.21 |