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NCT Number: NCT06076187

Protein Digestion After Bariatric Surgery in Older Adults

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?

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Key information

Conditions

Overweight and Obesity Aging Bariatric Surgery Candidate Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Protein Malabsorption Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Universitaire Ziekenhuizen KU Leuven, Leuven, Flemish Brabant, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dual isotope protein digestibility method

Other

Dual isotope method

Primary outcomes

  1. 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 contacts

Contact information is provided by the study sponsor or research team.

Bart Van der Schueren

CONTACT

Gabriel Eksteen, MSc

CONTACT

[email protected]

+32 16345708

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Acronym: ProDigBO

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Oct 10, 2023
Registry last updated
Feb 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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