---
title: Protein Supplementation and Resistance Training to Prevent Fat-Free Mass Loss Following Metabolic-Bariatric Surgery
nct_id: NCT07156552
overall_status: RECRUITING
phase: NA
sponsor: Radboud University Medical Center
study_type: INTERVENTIONAL
primary_condition: Bariatric Surgery
countries: Netherlands
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT07156552.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT07156552"
ct_last_update_post_date: 2025-09-05
last_seen_at: "2026-05-12T06:42:46.185Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Protein Supplementation and Resistance Training to Prevent Fat-Free Mass Loss Following Metabolic-Bariatric Surgery

**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

**NCT ID:** [NCT07156552](https://clinicaltrials.gov/study/NCT07156552)

## Key Facts

- **Status:** RECRUITING
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 400
- **Lead Sponsor:** Radboud University Medical Center
- **Collaborators:** Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC), ZonMw: The Netherlands Organisation for Health Research and Development, Nederlandse Obesitas Kliniek
- **Conditions:** Bariatric Surgery, Fat Free Mass
- **Start Date:** 2025-06-20
- **Completion Date:** 2027-06-30
- **CT.gov Last Update:** 2025-09-05

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **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
```

## Arms

- **Control group - Standard care** (NO_INTERVENTION)
- **Intervention group - Enriched care** (EXPERIMENTAL)

## Interventions

- **Resistance exercise training and protein supplementation** (BEHAVIORAL) — 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.

## Primary Outcomes

- **Prevalence of Fat-free mass loss/Total weight loss >30%** _(time frame: From enrollment to 3 months post-surgery)_

## Secondary Outcomes

- **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)_
- **Healthcare consumption (costs)** _(time frame: From enrollment to 12 months post-surgery)_
- **Blood marker HOMA-IR** _(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** _(time frame: From enrollment to 12 months post-surgery)_

## Locations (2)

- Nederlandse Obesitas Kliniek, Amsterdam, Netherlands — _NOT_YET_RECRUITING_
- Nederlandse Obesitas Kliniek, Nieuwegein, Netherlands — _RECRUITING_

## Recent Field Changes (last 30 days)

- `outcomes.primary` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.nederlandse obesitas kliniek|amsterdam||netherlands` — added _(2026-05-12)_
- `locations.nederlandse obesitas kliniek|nieuwegein||netherlands` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT07156552.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT07156552*  
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