Protein Digestion After Bariatric Surgery in Older Adults (ProDigBO)

February 25, 2025 updated by: Universitaire Ziekenhuizen KU Leuven

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?

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

72

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Bart Van der Schueren

Study Contact Backup

Study Locations

  • Belgium
    • Flemish Brabant
      • Leuven, Flemish Brabant, Belgium, 3000
        • Recruiting
        • Universitaire Ziekenhuizen KU Leuven
        • Contact:
    • Vlaams Brabant

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Subjects with overweight, obesity or after bariatric surgery

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1: Patients over 65 years of age who had undergone Roux-en-Y bariatric surgery
Other: Dual isotope protein digestibility method
Dual isotope method
Group 2: Patients over 65 years of age who had undergone sleeve gastrectomy surgery
Other: Dual isotope protein digestibility method
Dual isotope method
Group 3: Patients over 65 years of age without previous bariatric surgery
Other: Dual isotope protein digestibility method
Dual isotope method
Group 4: Patients younger than 65 years of age who had undergone Roux-en-Y bariatric surgery
Other: Dual isotope protein digestibility method
Dual isotope method
Group 5: Patients younger than 65 years of age who had undergone Sleeve Gastrectomy
Other: Dual isotope protein digestibility method
Dual isotope method
Group 6: Patients younger then 65 years of age without previous bariatric surgery
Other: Dual isotope protein digestibility method
Dual isotope method

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3,5 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitaire Ziekenhuizen KU Leuven

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 15, 2023

Primary Completion (Estimated)

November 25, 2026

Study Completion (Estimated)

November 25, 2026

Study Registration Dates

First Submitted

April 12, 2023

First Submitted That Met QC Criteria

October 6, 2023

First Posted (Actual)

October 10, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 25, 2025

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S67116

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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