We are interested to see whether a sulforaphane enriched diet will improve post-operative recovery in healthy patients who donate a kidney for the purpose of a kidney transplantation.
ID
Source
Brief title
Condition
- Other condition
- Renal and urinary tract therapeutic procedures
Synonym
Health condition
dieet interventies
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary:
- Serum: leukocytes, crp and pro-inflammatory cytokines (IL-6, TNF-a, IFN-g,
IL-10)
Secondary outcome
Secondary:
- Serum: sICAM, sVCM
- Biopsies: oxidative stress markers (Ho-1, SOD, GST)
- Questionnaires (VAS, euroqol, SF-36, MFI-20, werk en zorg)
Background summary
This research deals with the physical stress of surgery and recovery
thereafter. Previous research has shown that broccoli contains sulforaphane.
This substance is a well-known antioxidant and appears to reduce the level of
oxidative stress. Oxidative stress occurs in situations that could be harmful
to the body such as heat, UV light and smoking. This oxidative stress also
occurs during surgery. With this study we would like to assess whether a
broccoli enriched diet provides better resistance to oxidative stress and thus
to the outcome of the operation. Patients who are going to donate their kidney
for the purpose of transplantation (healthy) will be included in this study. 40
patients will be included en will be asked to consume standarized foodboxes the
five days before surgery. The foodboxes have no sulforphane containing
products. In the intervention group (n=20) an additonal sulforaphane rich
(broccoli cress shake) is added. Patients will have to visit the outpatient
department one extra time before surgery for a vena punction and to hear which
group they are randomized to. During surgery, after removal of the kidney, 3
biopsies will be taken. During admittance an additional blood tube will be
collected during the standard blood withdrawal. Furthermore, participants will
receive questionnaires about quality of life, pain, nausea and well-being (VAS
EuroQol SF-36, MFI 20, work and care) preoperatively, during hospitalization, 1
week, 2 weeks and 3 months after surgery. The serum will be tested on
leukocytes, CRP, pro-inflammatory cytokines (IL-6, TNF-a, IFN-g, IL-10),
intercellular cell adhesion molecules (ICAM), and vascular cell adhesion
molecule (VCAM) . The biopsies will be examined for markers of oxidative stress
(HO-1, SOD, GST).
Study objective
We are interested to see whether a sulforaphane enriched diet will improve
post-operative recovery in healthy patients who donate a kidney for the purpose
of a kidney transplantation.
Study design
This is a pilot study in which 50 healthy patients will be included who are
listed to donate a kidney for the purpose of a kidney transplantation.
- 25 patients will receive standarized foodboxes with an additional
sulforphane enriched shake (broccoli sprouts)
- 25 patients will only receive the standarized foodboxen
The foodboxes are the same in both groups and will not contain product with
sulforphane.
Intervention
Standarized food boxen with or without an additional sulforaphane enriched
broccoli sprouts shake.
Study burden and risks
Participant will undergo:
- 1 additional outpatient department visit including one extra vein puncture
(30min)
- 5 days preoperatively a standarized diet with or without the broccoli
sprouts diet
- Daily after surgery one extra tube of blood, besides the standard blood
withdrawal
- 3 kidney biopsies, after the kidney is removed from the participant
- Questionnaires: pre-operatively, daily for during admittance and 1 week, 2
weeks and 3 months after surgery. Filling out these questionnaire will take
about 10min
We expect no risks of this diet
's-Gravendijkwal 230
Rotterdam 3015 CE
NL
's-Gravendijkwal 230
Rotterdam 3015 CE
NL
Listed location countries
Age
Inclusion criteria
Healthy people who are listed to donate a kidney for the purpose of kidney transplantation
Exclusion criteria
- Age <18 years
- Standard use of corticosteroid or non-steroidal anti-inflammatory drugs (NSAIDs) medication that might influence inflammatory response
- multiple arteries of the kidney that will be donated (kidney recipients will then receive heparin postoperative, which increases the risk on post-operative bleeding from the biopsy sides)
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 | NL53890.078.15 |