Effect of protein supplementation on fat free mass preservation after bariatric surgery, a randomized double-blind placebo-controlled trial.

Effect of protein supplementation on fat free mass preservation after bariatric surgery, a randomized double-blind placebo-controlled trial. - PROMISE-study

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON51327

Enrollment

200

Registered

2022-05-09

Start date

2022-09-16

Completion date

Unknown

Last updated

2024-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

gastric bypass stomach reduction

Interventions

Inclusion will take place at the outpatient clinic of the bariatric expertise center of the Maasstad Hospital. Patients will be randomly assigned to either the intervention or control group before s

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: Patients who undergo bariatric surgery.

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
The main study parameter is the percentage fat free mass loss six months after surgery, calculated as fat free mass loss (kg) divided by total fat free mass (kg) before surgery. Fat free mass will be assessed by multi-frequency bioelectrical impedance analysis (MF-BIA).	—

Secondary

Measure	Time frame
Secondary parameters are total weight loss, BMI before and after surgery, fat mass, hand grip strength, physical activity and total protein intake.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)