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

NCT05570474 | Recruiting

• 1 other identifier: L2022059
• Study Type: interventional
• Target: 266
• Locations: 1 country
• Sites: 1

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.

Conditions

Bariatric Surgery Candidate; Protein Deficiency; Muscle Loss

Keywords

bariatric surgery; RYGB; Roux-en-Y gastric bypass; protein supplementation; fat free mass; muscle mass

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• percentage of fat free mass loss,

  Change of percentage fat free mass at 6 months post surgery compared to pre surgery

• total weight loss,

  pre surgery, 1 month after surgery, 3 months after surgery, 6 months after surgery, 12 months after surgery

• fat mass loss,

  Change of fat mass at 6 months post surgery compared to pre surgery

• BMI

  Change of BMI at 6 months post surgery compared to pre surgery

• hand grip strength,

  Change of hand grip strength at 6 months post surgery compared to pre surgery

Study Arms (2)

Protein

EXPERIMENTAL

Daily protein shake during 6 months after surgery

Dietary Supplement: Protein drink supplementation

Control

PLACEBO COMPARATOR

Daily placebo shake during 6 months after surgery

Dietary Supplement: Placebo

Interventions

Protein drink supplementation DIETARY_SUPPLEMENT

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

Protein

Placebo DIETARY_SUPPLEMENT

Daily placebo drink

Control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Maasstad Hospital: lead

Study Sites (1)

Maasstad Hospital

Rotterdam, South Holland, 3079DZ, Netherlands

RECRUITING

Related Publications (1)

• 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.

  PMID: 37946272 DERIVED

MeSH Terms

Conditions

Protein Deficiency; Muscular Atrophy

Condition Hierarchy (Ancestors)

Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Klaassen, MD

  Maasstad Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Taselaar, MD

CONTACT

0102912246; secretariaatbariatrie@maasstadziekenhuis.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are randomly allocated to either protein group or placebo group.

Study Record Dates

• First Submitted: September 26, 2022
• First Posted: October 6, 2022
• Study Start: September 1, 2022
• Primary Completion: April 1, 2024
• Study Completion: December 1, 2024
• Last Updated: March 13, 2024

Record last verified: 2024-03

Locations

NL (1)