Protein Digestion After Bariatric Surgery in Older Adults

Recruiting

• Conditions: Overweight and Obesity; Protein Malabsorption; Bariatric Surgery Candidate; Aging
• Interventions: Other: Dual isotope method

• Registration Number: NCT06076187
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

Brief Summary

The goal of this clinical trial is to investigate protein digestibility after bariatric surgery.

Does protein digestibility decrease after Roux-en-Y-Gastric Bypass? Does protein digestibility decrease after Sleeve Gastrectomy surgery? Does protein digestibility effect the ability to meet protein requirements?

Detailed Description

Purpose of clinical trial is to investigate the digestion of dietary protein in older patients who have undergone Roux-and-Y Bypass (RYGB) or sleeve gastrectomy (SG) surgery. The primary objective is to compare dietary protein digestion during a test meal who have previously undergone a RYGB surgery, SG surgery, or control patients, using a dual stable-isotope method. The secondary objectives are to investigate the relationship between protein intake corrected for protein digestion and skeletal muscle mass, and to investigate the relationship between the rate of free amino acid appearance and protein digestion.

Study Timeline

• Study First Submitted: 2023-04-12
• Study Start: 2023-05-15
• Study First Submitted QC: 2023-10-06
• Study First Posted: 2023-10-10
• Status Verified: 2024-02
• Last Update Submitted: 2025-02-25
• Last Update Posted: 2025-02-28
• Primary Completion: 2026-11-25
• Study Completion: 2026-11-25

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

• Signed informed consent
• Group 1,2,3: Age 65 years or older
• Group 4,5,6: Age 18 to 65 years
• Group 1,2,4,5: Previous bariatric surgery for obesity 1 - 10 years ago
• Group 3,6: No previous weight loss surgery

Exclusion Criteria

• Current diagnosis of cancer
• Advanced organ failure, including chronic kidney disease Stage 5, liver cirrhosis Stage 3, intestinal failure, heart failure stage D, or chronic obstructive pulmonary disease stage 4.
• Immobility
• Neuromuscular degenerative conditions
• Gastrointestinal conditions including coeliac disease, Crohn's disease, previous resection of the small intestine, gastroparesis
• Unable to follow the procedures of the studies due to cognitive impairment such as diagnosed dementia.
• Allergy/intolerance to milk, or soy or spirulina

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1: Patients over 65 years of age who had undergone Roux-en-Y bariatric surgery	Dual isotope method	Group 1: Patients over 65 years of age who had undergone Roux-en-Y bariatric surgery
Group 3: Patients over 65 years of age without previous bariatric surgery	Dual isotope method	Group 3: Patients over 65 years of age without previous bariatric surgery
Group 2: Patients over 65 years of age who had undergone sleeve gastrectomy surgery	Dual isotope method	Group 2: Patients over 65 years of age who had undergone sleeve gastrectomy surgery

Primary Outcome Measures

Name	Time	Method
The proportion of dietary protein digested as measured by the dual-isotope method.	3,5 hours	The proportion of dietary protein digested as measured by the dual-isotope method.

Trial Locations

Locations (2)

Universitaire Ziekenhuizen KU Leuven; 🇧🇪 Leuven, Flemish Brabant, Belgium

UZLeuven; 🇧🇪 Leuven, Vlaams Brabant, Belgium