The main aim of this study is to assess whether protein supplementation could prevent excessive fat free mass loss during the first year after bariatric surgery.
ID
Source
Brief title
Condition
- Appetite and general nutritional disorders
- Muscle disorders
- Gastrointestinal therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
Secondary parameters are total weight loss, BMI before and after surgery, fat
mass, hand grip strength, physical activity and total protein intake.
Background summary
Protein malnutrition is a severe complication of bariatric surgery and leads to
increased morbidity. Previous studies have shown that protein intake and
physical activity are the most important factors in the preservation of fat
free mass during weight loss. Low protein intake is very common in patients
undergoing bariatric surgery despite dietary counselling. Protein powder
supplements might help patients to achieve the protein intake recommendations
after bariatric surgery and could therefore contribute to preserve fat free
mass.
Study objective
The main aim of this study is to assess whether protein supplementation could
prevent excessive fat free mass loss during the first year after bariatric
surgery.
Study design
a randomized double-blind placebo-controlled trial
Intervention
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 surgery. The intervention group will
receive a clear protein powder shake of 200 ml containing 20 grams of whey
protein which should be taken daily during the first six months after LRYGB.
The control group will receive an isocaloric, clear, placebo shake containing
maltodextrine.
Study burden and risks
No additional outpatient visits will be required for study participants. A
three day food diary and physical activity questionnaire must be filled out by
all study participants at five regular follow-up moments. Body composition and
handgrip strength will be assessed during these visits. All study participants
will be asked to drink a daily shake, either protein or placebo, integrated in
their postoperative diet. Study participants will receive information about the
changes in body composition after surgery which is considered to be a
significant benefit for patients participating in this study.
Maasstadweg 21
rotterdam 3079DZ
NL
Maasstadweg 21
rotterdam 3079DZ
NL
Listed location countries
Age
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL80414.100.22 |