Impact of protein shakes on muscle preservation after weight loss surgery
Effect of Protein Supplementation on Fat Free Mass Preservation After Bariatric Surgery, a Randomized Double-blind Placebo-controlled Trial.
This study is testing if drinking a daily protein shake after weight loss surgery can help people keep their muscle mass during the first year after the surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 266 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Maasstad Hospital Academic / other |
| Locations | 1 site (Rotterdam, Zuid Holland) |
| Trial ID | NCT05570474 on ClinicalTrials.gov |
What this trial studies
This double-blind randomized placebo-controlled trial examines how daily protein supplementation affects fat free mass loss in patients who have undergone Roux-en-Y gastric bypass surgery. The study aims to determine if a clear protein powder shake, consumed daily for six months post-surgery, can help maintain muscle mass during the first year after the procedure. Participants will be randomly assigned to receive either the protein shake or a placebo, allowing for a direct comparison of outcomes related to muscle preservation.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-65 scheduled for laparoscopic Roux-en-Y gastric bypass with a BMI of 35 or higher and related severe comorbidities.
Not a fit: Patients who have had revisional bariatric surgery, are on a protein-restricted diet for medical reasons, or have certain muscular diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help bariatric surgery patients maintain muscle mass, reducing complications associated with protein deficiency.
How similar studies have performed: Previous studies have indicated that protein intake is crucial for preserving muscle mass during weight loss, suggesting that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Rotterdam, Zuid Holland
- Maasstad Hospital — Rotterdam, Zuid Holland, Netherlands (Recruiting)
Study contacts
- Principal investigator: Klaassen, MD — Maasstad Hospital
- Study coordinator: Taselaar, MD
- Email: secretariaatbariatrie@maasstadziekenhuis.nl
- Phone: 0102912246
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.