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

Recruiting
Conditions
gastric bypass
stomach reduction
10003018
10028302
10017998
Registration Number
NL-OMON51327
Lead Sponsor
Maasstadziekenhuis
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Not specified
Target Recruitment
200
Inclusion Criteria

Patients who undergo bariatric surgery.

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

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>The main study parameter is the percentage fat free mass loss six months after<br /><br>surgery, calculated as fat free mass loss (kg) divided by total fat free mass<br /><br>(kg) before surgery. Fat free mass will be assessed by multi-frequency<br /><br>bioelectrical impedance analysis (MF-BIA). </p><br>
Secondary Outcome Measures
NameTimeMethod
<p>Secondary parameters are total weight loss, BMI before and after surgery, fat<br /><br>mass, hand grip strength, physical activity and total protein intake. </p><br>
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