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.
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
- Are there results?
- None posted in the registry
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
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.
- 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 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.
- 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)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protein Digestion After Bariatric Surgery in Older Adults
- ClinicalTrials.gov ID
- NCT06076187
- Acronym / sponsor ID
- ProDigBO / S67116
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 15 May 2023 (actual)
- Primary completion
- 1 Apr 2026 (actual)
- Study completion
- 20 Apr 2026 (actual)
- First posted
- 10 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Group 1: Patients over 65 years of age who had undergone Roux-en-Y bariatric surgery | – | Other: Dual isotope protein digestibility methodGroup 1: Patients over 65 years of age who had undergone Roux-en-Y bariatric surgery |
| Group 2: Patients over 65 years of age who had undergone sleeve gastrectomy surgery | – | Other: Dual isotope protein digestibility methodGroup 2: Patients over 65 years of age who had undergone sleeve gastrectomy surgery |
| Group 3: Patients over 65 years of age without previous bariatric surgery | – | Other: Dual isotope protein digestibility methodGroup 3: Patients over 65 years of age without previous bariatric surgery |
| Group 4: Patients younger than 65 years of age who had undergone Roux-en-Y bariatric surgery | – | Other: Dual isotope protein digestibility methodGroup 4: Patients younger than 65 years of age who had undergone Roux-en-Y bariatric surgery |
| Group 5: Patients younger than 65 years of age who had undergone Sleeve Gastrectomy | – | Other: Dual isotope protein digestibility methodGroup 5: Patients younger than 65 years of age who had undergone Sleeve Gastrectomy |
| Group 6: Patients younger then 65 years of age without previous bariatric surgery | – | Other: Dual isotope protein digestibility methodGroup 6: Patients younger then 65 years of age without previous bariatric surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with overweight, obesity or after bariatric surgery
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dual isotope protein digestibility methodDual isotope method | Other | Group 1: Patients over 65 years of age who had undergone Roux-en-Y bariatric surgery, Group 2: Patients over 65 years of age who had undergone sleeve gastrectomy surgery, Group 3: Patients over 65 years of age without previous bariatric surgery, Group 4: Patients younger than 65 years of age who had undergone Roux-en-Y bariatric surgery, Group 5: Patients younger than 65 years of age who had undergone Sleeve Gastrectomy, Group 6: Patients younger then 65 years of age without previous bariatric surgery |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Overweight and Obesity and Bariatric Surgery Candidate, run by Universitaire Ziekenhuizen KU Leuven at 2 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of dietary protein digested as measured by the dual-isotope method. (time frame: 3,5 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.