Overweight and ObesityProDigBONCT06076187

Protein Digestion After Bariatric Surgery in Older Adults

An observational study of Overweight and Obesity and Bariatric Surgery Candidate, run by Universitaire Ziekenhuizen KU Leuven at 2 sites in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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? Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Overweight and Obesity, Bariatric Surgery Candidate, Aging
What is being tested?: Dual isotope protein digestibility method
How many people: 66 participants
Where: 2 sitesBelgium
Study dates: 15 May 2023to 20 Apr 2026
Phase: Observational

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Study population: Subjects with overweight, obesity or after bariatric surgery

Who may be able to join

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

Who cannot join

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 locations and contacts

2 sites in 1 country.

Belgium2 sites

Universitaire Ziekenhuizen KU Leuven
Leuven, Flemish Brabant, 3000
UZLeuven
Leuven, Vlaams Brabant, 3000

Other trials in Belgium

About this study

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?

Read the 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.

Conditions: Overweight and Obesity, Bariatric Surgery Candidate, Aging, Protein Malabsorption
Being tested: Dual isotope protein digestibility method
Medical subject headings: Overweight, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Dual isotope protein digestibility methodOther
Dual isotope method

Study groups in NCT06076187
Study group	Role	What they receive
Group 1: Patients over 65 years of age who had undergone Roux-en-Y bariatric surgery		Group 1: Patients over 65 years of age who had undergone Roux-en-Y bariatric surgery Receives: Other: Dual isotope protein digestibility method
Group 2: Patients over 65 years of age who had undergone sleeve gastrectomy surgery		Group 2: Patients over 65 years of age who had undergone sleeve gastrectomy surgery Receives: Other: Dual isotope protein digestibility method
Group 3: Patients over 65 years of age without previous bariatric surgery		Group 3: Patients over 65 years of age without previous bariatric surgery Receives: Other: Dual isotope protein digestibility method
Group 4: Patients younger than 65 years of age who had undergone Roux-en-Y bariatric surgery		Group 4: Patients younger than 65 years of age who had undergone Roux-en-Y bariatric surgery Receives: Other: Dual isotope protein digestibility method
Group 5: Patients younger than 65 years of age who had undergone Sleeve Gastrectomy		Group 5: Patients younger than 65 years of age who had undergone Sleeve Gastrectomy Receives: Other: Dual isotope protein digestibility method
Group 6: Patients younger then 65 years of age without previous bariatric surgery		Group 6: Patients younger then 65 years of age without previous bariatric surgery Receives: Other: Dual isotope protein digestibility method

What is being measured

The primary outcome is the main question the study is designed to answer.

The proportion of dietary protein digested as measured by the dual-isotope method.
The proportion of dietary protein digested as measured by the dual-isotope method.
Measured: 3,5 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 May 202320 Apr 2026

First posted10 Oct 2023
Study start15 May 2023
Primary completion1 Apr 2026
Study completion20 Apr 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Overweight and ObesityStudies of the same condition, open and under way.
More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Cross-sectional
Enrolment: 66 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06076187
Sponsor's protocol ID: S67116
Acronym: ProDigBO
Status last verified: Sep 2026
First submitted: 12 Apr 2023
Last updated: 4 Sep 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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