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

NCT ID: NCT05570474

Last Updated: 2024-03-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 266 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-01
• Study Completion Date: 2024-12-01

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.

Conditions

Bariatric Surgery Candidate; Protein Deficiency; Muscle Loss

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Protein

Daily protein shake during 6 months after surgery

Group Type: EXPERIMENTAL

Protein drink supplementation

Intervention Type: DIETARY_SUPPLEMENT

Daily drink containing 20 grams of whey protein, dissolved in 200mL water.

Control

Daily placebo shake during 6 months after surgery

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Daily placebo drink

Interventions

Protein drink supplementation

Daily drink containing 20 grams of whey protein, dissolved in 200mL water.

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Daily placebo drink

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Maasstad Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Klaassen, MD

Role: PRINCIPAL_INVESTIGATOR

Maasstad Hospital

Locations

Maasstad Hospital

Rotterdam, South Holland, Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Taselaar, MD

Role: CONTACT

secretariaatbariatrie@maasstadziekenhuis.nl

0102912246 ext. 0031

Facility Contacts

Taselaar, MD

Role: primary

References

Taselaar AE, Boes AJ, de Bruin RWF, Kuijper TM, Van Lancker K, van der Harst E, Klaassen RA. PROMISE: effect of protein supplementation on fat-free mass preservation after bariatric surgery, a randomized double-blind placebo-controlled trial. Trials. 2023 Nov 9;24(1):717. doi: 10.1186/s13063-023-07654-w.

Reference Type: DERIVED

PMID: 37946272 (View on PubMed)

Other Identifiers

L2022059

Identifier Type: -

Identifier Source: org_study_id