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Recruiting NCT07156552

NCT07156552 Protein Supplementation and Resistance Training to Prevent Fat-Free Mass Loss Following Metabolic-Bariatric Surgery

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Clinical Trial Summary
NCT ID NCT07156552
Status Recruiting
Phase
Sponsor Radboud University Medical Center
Condition Bariatric Surgery
Study Type INTERVENTIONAL
Enrollment 400 participants
Start Date 2025-06-20
Primary Completion 2027-05-30

Eligibility & Interventions

Sex All sexes
Min Age 18 Years
Max Age N/A
Study Type INTERVENTIONAL
Interventions
Resistance exercise training and protein supplementation

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 400 participants in total. It began in 2025-06-20 with a primary completion date of 2027-05-30.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

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 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

Contact & Investigator

Central Contact

J. H.M. Karregat, Dr.

✉ jan.karregat@radboudumc.nl

📞 +31653461919

Principal Investigator

M. T.E. Hopman, Prof. Dr.

PRINCIPAL INVESTIGATOR

Radboud University Medical Center

Frequently Asked Questions

Who can join the NCT07156552 clinical trial?

This trial is open to participants of all sexes, aged 18 Years or older, studying Bariatric Surgery. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT07156552 currently recruiting?

Yes, NCT07156552 is actively recruiting participants. Contact the research team at jan.karregat@radboudumc.nl for enrollment information.

Where is the NCT07156552 trial being conducted?

This trial is being conducted at Amsterdam, Netherlands, Nieuwegein, Netherlands.

Who is sponsoring the NCT07156552 clinical trial?

NCT07156552 is sponsored by Radboud University Medical Center. The principal investigator is M. T.E. Hopman, Prof. Dr. at Radboud University Medical Center. The trial plans to enroll 400 participants.

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