Bariatric Surgery Candidate Clinical Trial
— PROMISEOfficial title:
Effect of Protein Supplementation on Fat Free Mass Preservation After Bariatric Surgery, a Randomized Double-blind Placebo-controlled Trial.
This double blind randomized placebo controlled trial investigates the effect of protein supplementation on fat free mass loss in patients who underwent a Roux-en-Y gastric bypass.
Status | Recruiting |
Enrollment | 266 |
Est. completion date | December 1, 2024 |
Est. primary completion date | April 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Netherlands | Maasstad Hospital | Rotterdam | Zuid Holland |
Lead Sponsor | Collaborator |
---|---|
Maasstad Hospital |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Fat Free mass loss | Main study endpoint is percentage fat free mass loss at 6 months defined as fat free mass loss (kg) divided by total weight loss (kg) x 100%. Fat free mass will be assessed using the Seca® MBCA 515, which is a multi-frequency bio-electrical impedance analysis (MF-BIA). MF-BIA is an easy and non-invasive measurement tool and has been validated in morbid obese patients (13, 14). BIA measurements will be conducted under standardized circumstances. Patients can wear light clothes, have to empty their pockets and have to have an empty bladder. Patients will be asked to have no intensive physical activity and to have no food and fluid intake two hours prior to the measurements to minimalize bias. | Change of fat free mass at 6 months post surgery compared to pre surgery | |
Secondary | percentage of fat free mass loss, | measured by BIA | Change of percentage fat free mass at 6 months post surgery compared to pre surgery | |
Secondary | total weight loss, | measured by BIA | pre surgery, 1 month after surgery, 3 months after surgery, 6 months after surgery, 12 months after surgery | |
Secondary | fat mass loss, | measured by BIA | Change of fat mass at 6 months post surgery compared to pre surgery | |
Secondary | BMI | measured by BIA | Change of BMI at 6 months post surgery compared to pre surgery | |
Secondary | hand grip strength, | measured by hand grip strength device | Change of hand grip strength at 6 months post surgery compared to pre surgery | |
Secondary | total protein intake | measured by 3 day food diary | Change of total protein intake at 6 months post surgery compared to pre surgery |
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