NCT06076187

Brief 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?

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for all trials

Timeline
7mo left

Started May 2023

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress84%
May 2023Nov 2026

First Submitted

Initial submission to the registry

April 12, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

May 15, 2023

Completed
5 months until next milestone

First Posted

Study publicly available on registry

October 10, 2023

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 25, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 25, 2026

Last Updated

February 28, 2025

Status Verified

February 1, 2024

Enrollment Period

3.5 years

First QC Date

April 12, 2023

Last Update Submit

February 25, 2025

Conditions

Overweight and ObesityBariatric Surgery CandidateAgingProtein Malabsorption

Outcome Measures

Primary Outcomes (1)

  • 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.

    3,5 hours

Study Arms (6)

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

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

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

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

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

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

Other: Dual isotope protein digestibility method

Interventions

Dual isotope protein digestibility methodOTHER

Dual isotope method

Group 1: Patients over 65 years of age who had undergone Roux-en-Y bariatric surgeryGroup 2: Patients over 65 years of age who had undergone sleeve gastrectomy surgeryGroup 3: Patients over 65 years of age without previous bariatric surgeryGroup 4: Patients younger than 65 years of age who had undergone Roux-en-Y bariatric surgeryGroup 5: Patients younger than 65 years of age who had undergone Sleeve GastrectomyGroup 6: Patients younger then 65 years of age without previous bariatric surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects with overweight, obesity or after bariatric surgery

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Universitaire Ziekenhuizen KU Leuven

Leuven, Flemish Brabant, 3000, Belgium

RECRUITING

UZLeuven

Leuven, Vlaams Brabant, 3000, Belgium

RECRUITING

MeSH Terms

Conditions

OverweightObesity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Gabriel Eksteen, MSc

CONTACT

+32 16345708gabrieljohannes.eksteen@kuleuven.be

Bart Van der Schueren

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 12, 2023

First Posted

October 10, 2023

Study Start

May 15, 2023

Primary Completion (Estimated)

November 25, 2026

Study Completion (Estimated)

November 25, 2026

Last Updated

February 28, 2025

Record last verified: 2024-02

Locations

BE(2)