Bariatric Surgery, Fat Free Mass
Conditions
Keywords
Metabolic-Bariatric Surgery, Bariatric Surgery, Sleeve Gastrectomy, Roux-en Y Gastric Bypass, Protein Supplementation, Resistance Training
Brief summary
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.
Interventions
BEHAVIORALResistance exercise training and protein supplementation
The intervention consists of two components: 1. Resistance Exercise Training Participants will engage in a 24-week resistance training program. This program includes one supervised session per week supervised by a qualified kinesiologist, complemented by two to three additional unsupervised sessions per week performed at home. 2. Protein Supplementation Participants will receive daily protein supplements for a total duration of 12 weeks. The dosage will be progressively increased: * 20 grams per day during weeks 1-4 * 40 grams per day during weeks 5-8 * 60 grams per day during weeks 9-12 After the 12-week supplementation period, participants will receive additional dietary counseling sessions with a dietitian. These sessions aim to support the maintenance of adequate protein intake through dietary intake.
Sponsors
Radboud University Medical Center
Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)
ZonMw: The Netherlands Organisation for Health Research and Development
Nederlandse Obesitas Kliniek
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* A scheduled metabolic-bariatric surgery (i.e. RYGB or Sleeve Gastrectomy) * Participation in the NOK care program * Able to understand and perform the study procedures
Exclusion criteria
* Allergic or sensitive for milk proteins, or lactose intolerant * Diagnosed renal insufficiency * Diagnosed intestinal diseases influencing the uptake of protein (i.e. active inflammatory bowel disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Prevalence of Fat-free mass loss/Total weight loss >30% | From enrollment to 3 months post-surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | 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) | From enrollment to 12 months post-surgery | Based on a balance test (0-4 points), a gait speed test (0-4 points), and a repeated chair stand (0-4 points) |
| VO2max (L/min) | From enrollment to 12 months post-surgery | Assessment using the Astrand-Rhyming six minute cycle ergometer test |
| Incidence of gastrointestinal symptoms | From enrollment to 12 months post-surgery | Assessment using the Gastrointestinal Symptom Rating Scale (GSRS) questionnaire |
| Difference in Health-Related Quality of Life (HRQoL) | From enrollment to 12 months post-surgery | Assessment using the BODY-Q questionnaire |
| Healthcare consumption (costs) | From enrollment to 12 months post-surgery | — |
| Blood marker HOMA-IR | From enrollment to 12 months post-surgery | Based on fasted insulin (microU/mL) and glucose (mmol/L) levels |
| Blood marker high-sensitivity C-Reactive Protein (hs-CRP) (mg/L) | From enrollment to 12 months post-surgery | — |
| Blood marker lipid profile | From enrollment to 12 months post-surgery | Based on HDL-cholesterol (mg/dL), LDL-cholesterol (mg/dL), and triglycerides (mg/dL) |
Countries
Netherlands
Contacts
CONTACTJ. H.M. Karregat, Dr.
CONTACTB. M. de Roos, Drs.
PRINCIPAL_INVESTIGATORM. T.E. Hopman, Prof. Dr.
Radboud University Medical Center
Outcome results
None listed