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Recruiting NCT07156552

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

No phase Interventional Bariatric Surgery Fat Free Mass

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Resistance exercise training and protein supplementation.
Who it may be relevant to
Registry conditions: Bariatric Surgery, Fat Free Mass. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Netherlands
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Effectiveness of Protein SupplementatIon Combined With Resistance Exercise Training to Counteract Disproportional Fat-Free Mass Loss Following Metabolic-Bariatric Surgery: The ENRICHED Study

Overview

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

  • Behavioral Resistance 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

Primary outcome measures

  • Prevalence of Fat-free mass loss/Total weight loss >30% [Time frame: From enrollment to 3 months post-surgery]
Secondary outcome measures (12)
  • 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) [Time frame: From enrollment to 12 months post-surgery]
  • VO2max (L/min) [Time frame: From enrollment to 12 months post-surgery]
  • Incidence of gastrointestinal symptoms [Time frame: From enrollment to 12 months post-surgery]
  • Difference in Health-Related Quality of Life (HRQoL) [Time frame: From enrollment to 12 months post-surgery]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

Netherlands · 2 centers
  • Nederlandse Obesitas Kliniek — Amsterdam
  • Nederlandse Obesitas Kliniek — Nieuwegein

Publications

  • 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 PMID 41469063

Identifiers

NCT: NCT07156552 · NL87367.091.24

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗