Beneficial effects of caloric and protein restriction on markers of the stress response and postoperative recovery

Beneficial effects of caloric and protein restriction on markers of the stress response and postoperative recovery - PROTECT - the Protein and Caloric restriction Trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON41323

Enrollment

315

Registered

2012-07-31

Start date

2013-02-18

Completion date

Unknown

Last updated

2025-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

nierdonatie bij leven bariatric surgery healthy kidney donors

Interventions

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

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
- 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.	—

Measure

Time frame

- 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

Measure	Time frame
- 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.	—

Measure

Time frame

- 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.

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)