Skip to main content
Clinical Trials/NCT06076187
NCT06076187
Recruiting
Not Applicable

Protein Digestion After Bariatric Surgery in Older Adults

Universitaire Ziekenhuizen KU Leuven2 sites in 1 country72 target enrollmentMay 15, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Overweight and Obesity
Sponsor
Universitaire Ziekenhuizen KU Leuven
Enrollment
72
Locations
2
Primary Endpoint
The proportion of dietary protein digested as measured by the dual-isotope method.
Status
Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 15, 2023
End Date
November 25, 2026
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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
  • 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

Outcomes

Primary Outcomes

The proportion of dietary protein digested as measured by the dual-isotope method.

Time Frame: 3,5 hours

The proportion of dietary protein digested as measured by the dual-isotope method.

Study Sites (2)

Loading locations...

Similar Trials