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Recruiting NCT06076187

Protein Digestion After Bariatric Surgery in Older Adults

Observational Overweight and Obesity Bariatric Surgery Candidate Aging Protein Malabsorption

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Dual isotope protein digestibility method.
Who it may be relevant to
Registry conditions: Overweight and Obesity, Bariatric Surgery Candidate, Aging, Protein Malabsorption. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Belgium
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Other Dual isotope protein digestibility method
    Dual isotope method

Primary outcome measures

  • The proportion of dietary protein digested as measured by the dual-isotope method. [Time frame: 3,5 hours]

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 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Belgium · 2 centers
  • Universitaire Ziekenhuizen KU Leuven — Leuven
  • UZLeuven — Leuven

Identifiers

NCT: NCT06076187 · S67116

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗