Protein Digestion After Bariatric Surgery in Older Adults

NCT ID: NCT06076187

Last Updated: 2025-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

72 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-05-15

Study Completion Date

2026-11-25

Brief Summary

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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

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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

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Overweight and Obesity Bariatric Surgery Candidate Aging Protein Malabsorption

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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

Dual isotope protein digestibility method

Intervention Type OTHER

Dual isotope 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

Dual isotope protein digestibility method

Intervention Type OTHER

Dual isotope 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

Dual isotope protein digestibility method

Intervention Type OTHER

Dual isotope 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

Dual isotope protein digestibility method

Intervention Type OTHER

Dual isotope 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

Dual isotope protein digestibility method

Intervention Type OTHER

Dual isotope 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

Dual isotope protein digestibility method

Intervention Type OTHER

Dual isotope method

Interventions

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Dual isotope protein digestibility method

Dual isotope method

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Universitaire Ziekenhuizen KU Leuven

Leuven, Flemish Brabant, Belgium

Site Status RECRUITING

UZLeuven

Leuven, Vlaams Brabant, Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Gabriel Eksteen, MSc

Role: CONTACT

+32 16345708

Bart Van der Schueren

Role: CONTACT

Facility Contacts

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Gabriel Eksteen

Role: primary

0493921117

Gabriel Eksteen, MSc

Role: primary

003249392117

Other Identifiers

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S67116

Identifier Type: -

Identifier Source: org_study_id

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