Protein Digestion After Bariatric Surgery in Older Adults (ProDigBO)

Universitaire Ziekenhuizen KU Leuven

Status: Enrolling

Conditions: Aging; Bariatric Surgery Candidate; Overweight and Obesity; Protein Malabsorption

Treatments: Other: Dual isotope protein digestibility method

Study type: Observational

Funder types: Other

Identifiers

NCT06076187

S67116

Details and patient eligibility

About

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?

Full 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.

Enrollment: 72 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

72 participants in 6 patient groups

Group 1: Patients over 65 years of age who had undergone Roux-en-Y bariatric surgery

Description:

Group 1: Patients over 65 years of age who had undergone Roux-en-Y bariatric surgery

Treatment:

Other: Dual isotope protein digestibility method

Group 2: Patients over 65 years of age who had undergone sleeve gastrectomy surgery

Description:

Group 2: Patients over 65 years of age who had undergone sleeve gastrectomy surgery

Treatment:

Other: Dual isotope protein digestibility method

Group 3: Patients over 65 years of age without previous bariatric surgery

Description:

Group 3: Patients over 65 years of age without previous bariatric surgery

Treatment:

Other: Dual isotope protein digestibility method

Group 4: Patients younger than 65 years of age who had undergone Roux-en-Y bariatric surgery

Description:

Group 4: Patients younger than 65 years of age who had undergone Roux-en-Y bariatric surgery

Treatment:

Other: Dual isotope protein digestibility method

Group 5: Patients younger than 65 years of age who had undergone Sleeve Gastrectomy

Description:

Group 5: Patients younger than 65 years of age who had undergone Sleeve Gastrectomy

Treatment:

Other: Dual isotope protein digestibility method

Group 6: Patients younger then 65 years of age without previous bariatric surgery

Description:

Group 6: Patients younger then 65 years of age without previous bariatric surgery

Treatment:

Other: Dual isotope protein digestibility method