Effect of Protein Supplementation on Fat Free Mass Preservation After Bariatric Surgery (PROMISE)
Primary Purpose
Bariatric Surgery Candidate, Protein Deficiency, Muscle Loss
Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Protein drink supplementation
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Bariatric Surgery Candidate focused on measuring bariatric surgery, RYGB, Roux-en-Y gastric bypass, protein supplementation, fat free mass, muscle mass
Eligibility 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
Sites / Locations
- Maasstad HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Protein
Control
Arm Description
Daily protein shake during 6 months after surgery
Daily placebo shake during 6 months after surgery
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
percentage of fat free mass loss,
measured by BIA
total weight loss,
measured by BIA
fat mass loss,
measured by BIA
BMI
measured by BIA
hand grip strength,
measured by hand grip strength device
total protein intake
measured by 3 day food diary
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05570474
Brief Title
Effect of Protein Supplementation on Fat Free Mass Preservation After Bariatric Surgery
Acronym
PROMISE
Official Title
Effect of Protein Supplementation on Fat Free Mass Preservation After Bariatric Surgery, a Randomized Double-blind Placebo-controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
April 1, 2024 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maasstad Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
Rationale: 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.
Objective: The main aim of this study is to assess the effect of a daily consumed clear protein powder shake during the first six months after bariatric surgery on fat free mass loss in the first twelve months after laparoscopic Roux-en-Y gastric bypass (LRYGB).
Study design: Double-blind randomized placebo-controlled intervention study
Study population: Patients undergoing LRYGB at the bariatric expertise center for obesity of the Maasstad Hospital Rotterdam.
Intervention and procedure: Inclusion will take place at the outpatient clinic of the bariatric expertise center for obesity 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.
Main study parameters/endpoints: 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 weight loss (kg) x 100%. Fat free mass will be assessed by multi-frequency bioelectrical impedance analysis (MF-BIA). Secondary parameters are percentage fat free mass loss, total weight loss, fat mass loss, BMI, hand grip strength, total protein intake and its progression over time, measured at baseline, 3, 6 and 12 months of follow-up.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: 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. The risk of participation is considered low. The risk consists of a possible allergic reaction to either the protein shake or the placebo.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bariatric Surgery Candidate, Protein Deficiency, Muscle Loss
Keywords
bariatric surgery, RYGB, Roux-en-Y gastric bypass, protein supplementation, fat free mass, muscle mass
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants are randomly allocated to either protein group or placebo group.
Masking
ParticipantCare ProviderInvestigator
Masking Description
Study products (protein or placebo drinks) are provided to study participants. Study product is marked by a unique batch number, corresponding to protein or placebo in the ingredients list.
Allocation
Randomized
Enrollment
266 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Protein
Arm Type
Experimental
Arm Description
Daily protein shake during 6 months after surgery
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Daily placebo shake during 6 months after surgery
Intervention Type
Dietary Supplement
Intervention Name(s)
Protein drink supplementation
Intervention Description
Daily drink containing 20 grams of whey protein, dissolved in 200mL water.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Daily placebo drink
Primary Outcome Measure Information:
Title
Fat Free mass loss
Description
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.
Time Frame
Change of fat free mass at 6 months post surgery compared to pre surgery
Secondary Outcome Measure Information:
Title
percentage of fat free mass loss,
Description
measured by BIA
Time Frame
Change of percentage fat free mass at 6 months post surgery compared to pre surgery
Title
total weight loss,
Description
measured by BIA
Time Frame
pre surgery, 1 month after surgery, 3 months after surgery, 6 months after surgery, 12 months after surgery
Title
fat mass loss,
Description
measured by BIA
Time Frame
Change of fat mass at 6 months post surgery compared to pre surgery
Title
BMI
Description
measured by BIA
Time Frame
Change of BMI at 6 months post surgery compared to pre surgery
Title
hand grip strength,
Description
measured by hand grip strength device
Time Frame
Change of hand grip strength at 6 months post surgery compared to pre surgery
Title
total protein intake
Description
measured by 3 day food diary
Time Frame
Change of total protein intake at 6 months post surgery compared to pre surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Taselaar, MD
Phone
0102912246
Ext
0031
Email
secretariaatbariatrie@maasstadziekenhuis.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Klaassen, MD
Organizational Affiliation
Maasstad Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maasstad Hospital
City
Rotterdam
State/Province
Zuid Holland
ZIP/Postal Code
3079DZ
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Taselaar, MD
First Name & Middle Initial & Last Name & Degree
Rene Klaassen, MD
12. IPD Sharing Statement
Learn more about this trial
Effect of Protein Supplementation on Fat Free Mass Preservation After Bariatric Surgery
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