To investigate the feasibility and safety of a diet containing 30% caloric and 70% protein restriction given during five days in healthy kidney donors planned to undergo a live kidney donation as well as persons awaiting bariatric surgery.…
ID
Source
Brief title
Condition
- Other condition
- Appetite and general nutritional disorders
- Gastrointestinal therapeutic procedures
Synonym
Health condition
nierdonatie bij leven
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Primary outcome measure in phase 1 is the objective feasibility measured as
the percentage of patients completing the diet, reasons for not adhering to the
diet (if applicable) and the levels of metabolic parameters.
- Primary parameter in phase 1c is the effect of morbid obesity on different
ages on telomere length in leukocytes.
- Primary parameter in phase 1d/ phase 1e (validation of telomere length
measurement and measurement telomerase activity) is the effect of morbid
obesity, the metabole syndrome and bariatric surgery on telomere length and
telomerase activity in leukocytes.
- Main study parameters in phase 2 are markers of the adaptive stress response
at mRNA and protein level measured in tissue biopsies obtained perioperatively.
Secondary outcome
- Phase 1: subjective feasibility of a diet containing caloric and protein
restriction.
- Phase 1d/ phase 1e (measurement of telomere length): the role of bariatric
surgery on the telomere attrition induced by morbid obesity via measurement of
telomere lengths before and at timepoints 3, 6, 12 and 24 months after
bariatric surgery.
- Phase 2: the effects of a diet consisting of caloric and protein restriction
on the subjective postoperative recovery, the acute phase response and
metabolic parameters.
Background summary
Animal studies over the past years have shown that caloric restriction (CR),
the reduction of the amount of calories in our diet without causing
malnutrition, has many positive effects like the extension of the lifespan.
This response is collectively called the adaptive stress response. The precise
etiology underlying this response is still unknown. One of the factors playing
an important role is the better resistance against oxidative stress. Recently
discovered is the role of protein restriction in this process. Previously to
this research, a clinical study is performed in live healthy kidney donors
given a diet of 3 days of 30% caloric restriction and 24 hours of fasting. This
study showed the feasibility of such a diet in patients. With the present
study, we first like to investigate the safety and feasibility of a caloric and
protein restricted diet in a clinical setting. In the second phase we aim to
study the mRNA and protein levels of markers of the adaptive stress response at
a tissue level as well as the postoperative recovery.
Study objective
To investigate the feasibility and safety of a diet containing 30% caloric and
70% protein restriction given during five days in healthy kidney donors planned
to undergo a live kidney donation as well as persons awaiting bariatric
surgery. Subsequently, the effects of the diet on the mRNA and protein
expression levels of markers of the adaptive stress response will be
determined. This is done in patients undergoing live kidney donation or
bariatric surgery. In addition, the postoperative subjective recovery and the
perioperative cytokine response after a caloric and protein restricted diet
will be measured.
Study design
A randomised controlled study, divided into two phases. Phase 1 is a pilot
study and investigates the feasibility and safety of a diet containing caloric
and protein restriction. The diet is given while patients are awaiting surgery.
Phase 2 investigates the effects of the diet when given before surgery on
markers of the stress response, the acute phase response and postoperative
recovery. Pre- and postoperatively, several extra blood samples are taken. In
phase 2, at the beginning of the surgery biopsies of the liver, the muscle
(musculus rectus abdominis) and the abdominal fat (visceral and subcutaneous
fat) are taken. In phase 2a, biopsies of the kidney will be taken in the live
kidney donors at three different time points during surgery. Pre- and
postoperatively, patients are asked to fill in questionnaires about their
quality of life, pain scores, nausea and fatigue.
Intervention
The nutritional interventional consists of a synthetic diet consisting of 30%
caloric and 70% protein restriction, calculated by means of the daily energy
requirements via de Harris-Benedict formula. Groups receiving a synthetic diet
isocaloric to a normal diet or a normal diet measured via a dietary diary are
used as controls. In phase 1, the diet will be given while the patients are
awaiting surgery without inclusion of the surgery. In phase 2, the diet will be
given preoperatively. In phase 2, no more patients will be randomized in the
group receiving the synthetic isocaloric diet.
Study burden and risks
- In the intervention group, feelings of hunger and light-headedness may occur
during the diet.
- The control group without intervention is asked to keep up a dietary diary.
- Several questionnaires are asked to be filled in pre- and postoperatively.
- Biopsies of liver, muscle and fat are taken perioperatively (only in phase 2).
- In phase 2a, in live kidney donors biopsies of the kidney will be taken
perioperatively at three different time points.
- Several extra blood samples are taken pre- and postoperatively.
- Phase 1c (measurement of telomere length): one extra blood sample is taken
during the outpatient clinic.
- Phase 1d/ phase 1e (validation of measurement of telomere length and
measurement telomerase activity): five times two extra blood samples taken
before and after bariatric surgery during visits at the outpatient clinic.
Antonie van Leeuwenhoeklaan 9
Bilthoven 3721 MA
NL
Antonie van Leeuwenhoeklaan 9
Bilthoven 3721 MA
NL
Listed location countries
Age
Inclusion criteria
- scheduled for (phase 1a) or undergoing (phase 2a) laparoscopic live kidney nephrectomy
- scheduled for (phase 1b, phase 1c, phase 1d, phase 1e) and/or undergoing (phase 2b, phase 1d, phase 1e) laparoscopic bariatric surgery
Exclusion criteria
Phase 1a (awaiting live kidney donation):
- Allergic to any of the ingredients of the diet
- Participation in another clinical trial within the last 30 days
Phase 1b (awaiting bariatric surgery):
- Allergic to any of the ingredients of the diet
- Participation in another clinical trial within the last 30 days
- BMI < 40
- Co-morbidities as in diabetes mellitus
- Morbid obesity caused by genetic defects or syndromes
Phase 1c (telomere length measurement):
- BMI < 40
- Co-morbidities as in diabetes mellitus
- Morbid obesity caused by genetic defects/syndromes
Phase 1d/Phase 1e (validation of telomere lenght measurement and measurement telomerase activity):
- BMI < 35
- Morbid obesity caused by genetic defects/syndromes
Phase 2a (undergoing live kidney donation):
- Allergic to any of the ingredients of the diet
- Bilateral abnormalities of the renal arteries (origin stenosis)
- Previous operations of the kidney(s) or adrenals gland(s)
- Radiological abnormalities necessitating an open approach
- Perioperative conversion to an open approach
- Participation in another clinical trial within the last 30 days
- Usage of therapeutic anti-clotting medication
Phase 2b (undergoing bariatric surgery):
- Allergic to any of the ingredients of the diet
- Previous operations of the stomach or duodenum
- Any abnormalities necessitating an open approach
- Perioperative conversion to an open approach
- Participation in another clinical trial within the last 30 days
- Liver abnormalities found perioperatively necessitating postponing of surgery
- Preoperative risk assessment necessitating nutritional intervention
- BMI < 40
- Co-morbidity as in diabetes mellitus
- Morbid obesity caused by genetic defects or syndromes
- Usage of therapeutic anti-clotting medication
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL39461.078.12 |
| OMON | NL-OMON28311 |