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| Name | Class |
|---|---|
| Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC) | OTHER |
| ZonMw: The Netherlands Organisation for Health Research and Development | OTHER |
| Nederlandse Obesitas Kliniek | OTHER |
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The goal of this clinical trial is to investigate the effects of daily protein supplementation and participation in a weekly supervised resistance training program on the prevention of excessive muscle mass loss following bariatric surgery. Patients treated at one of the participating centers will be invited to participate and will be randomly assigned to one of two groups.
Participants in group 1 will receive standard postoperative care as currently provided. Participants in group 2 will also receive standard care, but in addition, they will be asked to consume extra protein daily and take part in a supervised resistance training session once a week.
Previous research has shown that approximately one in five patients undergoing bariatric surgery experiences excessive muscle loss after the surgery. It is known that resistance training and protein intake can help maintain and even improve muscle mass. However, limited research has been conducted on the combined effects of protein supplementation and resistance training in patients after bariatric surgery. Therefore, the aim of this trial is to determine whether participants receiving the additional intervention experience less muscle mass loss compared to those receiving standard care alone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group - Standard care | No Intervention | ||
| Intervention group - Enriched care | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Resistance exercise training and protein supplementation | Behavioral | The intervention consists of two components:
Participants will receive daily protein supplements for a total duration of 12 weeks. The dosage will be progressively increased:
|
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of Fat-free mass loss/Total weight loss >30% | From enrollment to 3 months post-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Weight (kg) | From enrollment to 12 months post-surgery | |
| Body Mass Index (kg/m2) | From enrollment to 12 months post-surgery | |
| Body composition (fat-mass/fat-free mass) (kg) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| J. H.M. Karregat, Dr. | Contact | +31653461919 | jan.karregat@radboudumc.nl | |
| B. M. de Roos, Drs. | Contact | +31681363125 | bente.deroos@radboudumc.nl |
| Name | Affiliation | Role |
|---|---|---|
| M. T.E. Hopman, Prof. Dr. | Radboud University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nederlandse Obesitas Kliniek | Not yet recruiting | Amsterdam | 1043 DS | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41469063 | Derived | de Roos BM, Yeh LY, van den Hooff PS, Nuijten MAH, Twisk JWR, Liem RSL, van Acker GJD, Severens JL, Kambic T, Serlie MJM, Monpellier VM, Eijsvogels TMH, Hopman MTE, Karregat JHM. Effectiveness of protein supplementation combined with resistance training to counteract disproportional fat-free mass loss following metabolic bariatric surgery: rationale and design of the ENRICHED randomised controlled trial. BMJ Open. 2025 Dec 29;15(12):e108346. doi: 10.1136/bmjopen-2025-108346. |
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|
| From enrollment to 12 months post-surgery |
| Waist circumference (cm) | From enrollment to 12 months post-surgery |
| Blood pressure (mmHg) | From enrollment to 12 months post-surgery |
| Quadriceps isometric strength (kg) | From enrollment to 12 months post-surgery |
| Quadriceps isometric power (Watt) | From enrollment to 12 months post-surgery |
| Handgrip strength (kg) | From enrollment to 12 months post-surgery |
| Short Physical Performance Battery (SPPB) score (scale 1-12 points) | Based on a balance test (0-4 points), a gait speed test (0-4 points), and a repeated chair stand (0-4 points) | From enrollment to 12 months post-surgery |
| VO2max (L/min) | Assessment using the Astrand-Rhyming six minute cycle ergometer test | From enrollment to 12 months post-surgery |
| Incidence of gastrointestinal symptoms | Assessment using the Gastrointestinal Symptom Rating Scale (GSRS) questionnaire | From enrollment to 12 months post-surgery |
| Difference in Health-Related Quality of Life (HRQoL) | Assessment using the BODY-Q questionnaire | From enrollment to 12 months post-surgery |
| Healthcare consumption (costs) | From enrollment to 12 months post-surgery |
| Blood marker HOMA-IR | Based on fasted insulin (microU/mL) and glucose (mmol/L) levels | From enrollment to 12 months post-surgery |
| Blood marker high-sensitivity C-Reactive Protein (hs-CRP) (mg/L) | From enrollment to 12 months post-surgery |
| Blood marker lipid profile | Based on HDL-cholesterol (mg/dL), LDL-cholesterol (mg/dL), and triglycerides (mg/dL) | From enrollment to 12 months post-surgery |
| Nederlandse Obesitas Kliniek | Recruiting | Nieuwegein | 3431 | Netherlands |
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