Effect of Protein Supplementation on Fat Free Mass Preservation After Bariatric Surgery (PROMISE)

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.

Study Overview

• Status: Recruiting
• Conditions: Bariatric Surgery Candidate; Muscle Loss; Protein Deficiency
• Intervention / Treatment: Dietary supplement: Protein drink supplementation; Dietary supplement: Placebo

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.

• Study Type: Interventional
• Enrollment (Estimated): 266
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Taselaar, MD; Phone Number: 0031 0102912246; Email: secretariaatbariatrie@maasstadziekenhuis.nl

Study Locations

• Netherlands
  • Zuid Holland
    • Rotterdam, Zuid Holland, Netherlands, 3079DZ
      • Recruiting
      • Maasstad Hospital
      • Contact: Taselaar, MD
      • Principal Investigator: Rene Klaassen, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Protein; Daily protein shake during 6 months after surgery	Dietary supplement: Protein drink supplementation; Daily drink containing 20 grams of whey protein, dissolved in 200mL water.
Placebo Comparator: Control; Daily placebo shake during 6 months after surgery	Dietary supplement: Placebo; Daily placebo drink

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
percentage of fat free mass loss,	measured by BIA	Change of percentage fat free mass at 6 months post surgery compared to pre surgery
total weight loss,	measured by BIA	pre surgery, 1 month after surgery, 3 months after surgery, 6 months after surgery, 12 months after surgery
fat mass loss,	measured by BIA	Change of fat mass at 6 months post surgery compared to pre surgery
BMI	measured by BIA	Change of BMI at 6 months post surgery compared to pre surgery
hand grip strength,	measured by hand grip strength device	Change of hand grip strength at 6 months post surgery compared to pre surgery
total protein intake	measured by 3 day food diary	Change of total protein intake at 6 months post surgery compared to pre surgery

Collaborators and Investigators

• Sponsor: Maasstad Hospital
• Investigators: Principal Investigator: Klaassen, MD, Maasstad Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: September 26, 2022
• First Submitted That Met QC Criteria: October 5, 2022
• First Posted (Actual): October 6, 2022

Study Record Updates

• Last Update Posted (Actual): March 13, 2024
• Last Update Submitted That Met QC Criteria: March 12, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: bariatric surgery; muscle mass; fat free mass; protein supplementation; Roux-en-Y gastric bypass; RYGB
• Additional Relevant MeSH Terms: Nutrition Disorders; Deficiency Diseases; Malnutrition; Protein Deficiency
• Other Study ID Numbers: L2022059

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No