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ENRICHED

Effectiveness of protein supplementatIon combined with resistance exercise training to counteract disproportional fat-free mass loss following metabolic-bariatric surgery: the ENRICHED study. - ENRICHED

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON57119
Enrollment
400
Registered
2024-07-09
Start date
2025-06-20
Completion date
Unknown
Last updated
2025-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Disproportional fat-free mass loss, metabolic bariatric surgery, protein supplementation, resistance excercise Muscle loss, weight-loss surgery, protein supplementation, strenght training

Interventions

During the 6-month intervention period, the control group follows standard care protocols, while standard care is complemented by additional protein intake, resistance training and counseling sessions
protein-rich food products into the daily&nbsp
intake pattern is made. Counseling sessions with dieticians are offered during the intervention periode to support participants with the dietary adjustments.&nbsp
Furthermore, participants in the intervention group will be invited to join supervised group sessions of resistance exercise at their NOK center once a week. Next to these sessions, patients are instr
&nbsp
Given the gastrointestinal and physical limitations postoperatively, the protein and resistance training interventions will commence three weeks after the surgical procedure. After the intervention pe
Measurements are performed before MBS, and 3-, 6-, and 12-months after MBS.

Sponsors

Radboud Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - A scheduled metabolic bariatric surgery procedure (i.e., a RYGB or sleeve gastrectomy) - Participation in the NOK care program - Able to understand and perform the study procedures

Exclusion criteria

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, Crohn's disease) - Inability to perform any resistance training exercises (e.g., severe physical  limitations) - Inability to comprehend scheduled procedures (e.g., language barriers)

Design outcomes

Primary

MeasureTime frame
Our primary outcome is the prevalence of disproportional FFM loss, defined as FFML/WL>30%. Changes in body composition, such as FFM loss and weight loss (WL) are determined by bioelectrical impedance analysis (BIA) in the total population (N=400); and by Dual Energy X-ray Absorptiometry (DXA) in a subgroup (n=100).

Secondary

MeasureTime frame
Secondary outcomes are body composition, (cardio)metabolic health, muscle strength, muscle function, cardiorespiratory fitness and health-related quality of life, and healthcare consumption.

Countries

Netherlands

Contacts

Public ContactJ.H.M. Karregat

Radboud Universitair Medisch Centrum

enriched@obesitaskliniek.nl024 3614468

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Feb 2, 2026