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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
400
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.
Nederlandse Obesitas Kliniek
Amsterdam, Netherlands
NOT_YET_RECRUITINGNederlandse Obesitas Kliniek
Nieuwegein, Netherlands
RECRUITINGPrevalence of Fat-free mass loss/Total weight loss >30%
Time frame: From enrollment to 3 months post-surgery
Weight (kg)
Time frame: From enrollment to 12 months post-surgery
Body Mass Index (kg/m2)
Time frame: From enrollment to 12 months post-surgery
Body composition (fat-mass/fat-free mass) (kg)
Time frame: From enrollment to 12 months post-surgery
Waist circumference (cm)
Time frame: From enrollment to 12 months post-surgery
Blood pressure (mmHg)
Time frame: From enrollment to 12 months post-surgery
Quadriceps isometric strength (kg)
Time frame: From enrollment to 12 months post-surgery
Quadriceps isometric power (Watt)
Time frame: From enrollment to 12 months post-surgery
Handgrip strength (kg)
Time frame: 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)
Time frame: From enrollment to 12 months post-surgery
VO2max (L/min)
Assessment using the Astrand-Rhyming six minute cycle ergometer test
Time frame: From enrollment to 12 months post-surgery
Incidence of gastrointestinal symptoms
Assessment using the Gastrointestinal Symptom Rating Scale (GSRS) questionnaire
Time frame: From enrollment to 12 months post-surgery
Difference in Health-Related Quality of Life (HRQoL)
Assessment using the BODY-Q questionnaire
Time frame: From enrollment to 12 months post-surgery
Healthcare consumption (costs)
Time frame: From enrollment to 12 months post-surgery
Blood marker HOMA-IR
Based on fasted insulin (microU/mL) and glucose (mmol/L) levels
Time frame: From enrollment to 12 months post-surgery
Blood marker high-sensitivity C-Reactive Protein (hs-CRP) (mg/L)
Time frame: 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)
Time frame: From enrollment to 12 months post-surgery
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