Protein Supplementation and Resistance Training to Prevent Fat-Free Mass Loss Following Metabolic-Bariatric Surgery

Not Applicable

Recruiting

• Conditions: Bariatric Surgery; Fat Free Mass

• Registration Number: NCT07156552
• Lead Sponsor: Radboud University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-06
• Study Start: 2025-06-20
• Study First Submitted: 2025-07-22
• Study First Submitted QC: 2025-08-27
• Last Update Submitted: 2025-08-27
• Study First Posted: 2025-09-05
• Last Update Posted: 2025-09-05
• Primary Completion: 2026-09-30
• Study Completion: 2027-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Prevalence of Fat-free mass loss/Total weight loss >30%	From enrollment to 3 months post-surgery

Secondary Outcome Measures

Name	Time	Method
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
Difference in Health-Related Quality of Life (HRQoL)	From enrollment to 12 months post-surgery	Assessment using the BODY-Q questionnaire
Incidence of gastrointestinal symptoms	From enrollment to 12 months post-surgery	Assessment using the Gastrointestinal Symptom Rating Scale (GSRS) questionnaire
Blood marker high-sensitivity C-Reactive Protein (hs-CRP) (mg/L)	From enrollment to 12 months post-surgery
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 lipid profile	From enrollment to 12 months post-surgery	Based on HDL-cholesterol (mg/dL), LDL-cholesterol (mg/dL), and triglycerides (mg/dL)

Trial Locations

Locations (1)

Nederlandse Obesitas Kliniek; 🇳🇱 Nieuwegein, Netherlands