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Search / Trial NCT05570474

Effect of Protein Supplementation on Fat Free Mass Preservation After Bariatric Surgery

Launched by MAASSTAD HOSPITAL · Oct 5, 2022

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Bariatric Surgery Rygb Roux En Y Gastric Bypass Protein Supplementation Fat Free Mass Muscle Mass

ClinConnect Summary

This clinical trial is looking at how protein supplements can help people who have undergone Roux-en-Y gastric bypass surgery maintain their muscle mass, which is important for overall health. The study is double-blind, meaning neither the participants nor the researchers know who is receiving the protein supplement or a placebo (a non-active substitute). This helps ensure the results are reliable. The trial is currently recruiting participants aged 18 to 65 who are scheduled for this type of surgery and have a body mass index (BMI) of 35 or higher, along with serious health issues related to obesity, such as type 2 diabetes or high blood pressure.

If you are chosen to participate, you will receive either the protein supplement or a placebo to drink daily. The goal is to see if the protein helps you keep more of your muscle mass after surgery, which can be a common challenge. It's important to note that individuals with certain conditions, like muscle diseases or allergies to the ingredients in the shakes, cannot participate. Overall, this study aims to find ways to support patients better during their recovery from bariatric surgery.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • - Scheduled for a laparoscopic Roux-en-Y Gastric Bypass
  • Age 18 - 65 years
  • Body Mass Index ≥ 35 with the presence of severe comorbidity related to morbid obesity (diabetes mellitus type 2, obstructive sleep apnoea syndrome (OSAS), hypertension, etc.) or a BMI ≥ 40 with or without the presence of severe comorbidity related to morbid obesity
  • Written informed consent
  • Exclusion Criteria:
  • - Revisional bariatric surgery
  • A protein-restricted diet for medical reasons
  • Diagnosis of a (neuro-) muscular disease
  • Inability to undergo MF-BIA (i.e. pregnancy, pacemaker)
  • Allergy to any of the ingredients of either the protein or the placebo shake

About Maasstad Hospital

Maasstad Hospital is a leading healthcare institution dedicated to advancing medical research and improving patient care through innovative clinical trials. Situated in Rotterdam, the hospital is renowned for its multidisciplinary approach, fostering collaboration among healthcare professionals to explore cutting-edge treatments and therapies. With a strong commitment to ethical standards and patient safety, Maasstad Hospital prioritizes rigorous methodologies and comprehensive data analysis in its trials. The institution aims to contribute significantly to medical knowledge and enhance therapeutic options for various conditions, ultimately benefiting patients and the broader medical community.

Locations

Rotterdam, Zuid Holland, Netherlands

Patients applied

0 patients applied

Trial Officials

Klaassen, MD

Principal Investigator

Maasstad Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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