|- candidate number||13435|
|- NTR Number||NTR3663|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||12-okt-2012|
|- Secondary IDs||NL 39461.078.12 / S/340005; CCMO / Monitoring Human Ageing|
|- Public Title||Postoperative effects of preoperative caloric and protein restriction.|
|- Scientific Title||Beneficial effects of caloric and protein restriction on markers of the stress response and postoperative recovery following surgery.|
|- hypothesis||A protein and caloric restricted diet is feasible and safe and induces a protective stress response in patients undergoing live kidney nephrectomy or bariatric surgery.|
|- Healt Condition(s) or Problem(s) studied||Live kidney donors, Bariatric surgery, Obesity-induced inflammation, Dietary restriction|
|- Inclusion criteria||Group 1: |
1. Live laparoscopic donor nephrectomy;
2. 18-55 years old;
3. BMI > 19.
1. Laparoscopic bariatric surgery;
2. 18-55 years old;
3. BMI > 40.
|- Exclusion criteria||Group 1: Allergic to the ingredients of the diet, bilateral abnormalities of the renal arteries, previous operations of the kidney(s) or adrenals gland(s), an open surgical approach.|
Group 2: Allergic to the ingredients of the diet, other operations methods than the Roux-en-Y gastric bypass, previous operations of the stomach or duodenum, an open surgical approach, co-morbidity as in diabetes mellitus, morbid obesity caused by genetic defects/syndromes, another preoperative nutritional intervention necessary because of liver abnormalities.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-nov-2012|
|- planned closingdate||1-mei-2014|
|- Target number of participants||150|
|- Interventions||1. A synthetic diet containing an estimate of 30% caloric restriction and 70% protein restriction that is based on the daily energy requirements;|
2. Synthetic diet that is isocaloric to the daily energy requirements;
3. A control diet without any intervention with measurement of the nutritional intake via a dietary diary.
|- Primary outcome||1. Safety and feasibility of a caloric and protein restricted diet measured by side-effects and metabolic parameters;|
2. Induction of the protective stress response via a caloric and protein restricted diet, measured by markers of the stress response in tissue (biopsies) and blood.
|- Secondary outcome||1. Effect on subjective wellbeing and postoperative recovery after a caloric and protein restricted diet via questionnaires;|
2. Acute phase response via blood samples.
|- Timepoints||Day -6, -1, +1, +2, +3, week 1, 2, month 1, 3, 6.|
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||MD. F. Jongbloed|
|- CONTACT for SCIENTIFIC QUERIES||Prof. dr. J.N.M. IJzermans|
|- Sponsor/Initiator ||Rijksinstituut voor Volksgezondheid en Milieu (RIVM), Erasmus Medical Center|
(Source(s) of Monetary or Material Support)
|Rijksinstituut voor Volksgezondheid en Milieu (RIVM)|
|- Brief 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. |
|- Main changes (audit trail)|
|- RECORD||12-okt-2012 - 21-feb-2013|