Protein Requirements After Bariatric Surgery

NCT06853652 | Recruiting

• 1 other identifier: S69673
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The study investigates protein requirements at least 1 year after gastric bypass surgery in adult males, to investigate whether protein requirements are elevated compared to protein requiremens for the general populaiotn. The main study outcome is the estimated average protein requirements for the study populaiton.

Conditions

Obesity and Overweight; Bariatric Surgery (Gastric Bypass); Protein Requirement

Outcome Measures

Primary Outcomes (1)

• estimated average protein requirements

  Estimated protien requirements will be calculated for the total study population, not per participant, and expressed as g/kg bodyweight and g/kg fat free mass

  Postprandial plateau in amino acid oxidation, after 8 hours of feeding. 49 studies (7 at 7 protein intake levels each) will be conducted over 6 months to determine to outcome collectively for all participants.

Study Arms (1)

Male adults with previous RYGB surgery

Male adults with previous RYGB surgery

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants for the study will be recruited among the patients of the Obesity Clinic of the University Hospitals Leuven (UZ Leuven Obesity Clinic) or from individuals recruited through patients-groups.

You may qualify if:

• Male aged 18 - 65 years,
• Primary RYGB surgery one to ten years before,
• Weight stable within 5% over the last 3 months,
• Normotensive or blood pressure controlled with antihypertensive therapy,
• Provision of informed consent to participate,

You may not qualify if:

• Current diagnosis of cancer or active cancer in the preceding 1 year,
• Any chronic or acute disease which is known to affect amino acid absorption, metabolism, or requirements,
• Weight loss after bariatric surgery of less than 40% of excess weight,
• Weight regain after bariatric surgery greater than 20% of nadir weight,
• Diabetes mellitus defined as a fasting plasma glucose concentration ≥ 7.0 mmol, or HbA1c less than 6.5%, or medical treatment for diabetes.

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

Universitaire Ziekenhuizen KU Leuven

Leuven, 3000, Belgium

RECRUITING

MeSH Terms

Conditions

Obesity; Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Bart Van der Schueren, MD PhD

  KU Leuven

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gabriel Eksteen, MSc

CONTACT

+32 16345708; gabrieljohannes.eksteen@kuleuven.be

Christophe Matthys, PhD

CONTACT

christophe.matthys@uzleuven.be

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2025
• First Posted: March 3, 2025
• Study Start: March 17, 2025
• Primary Completion (Estimated): June 25, 2026
• Study Completion (Estimated): June 25, 2026
• Last Updated: March 3, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Time Frame: Study data will be made available upon publication of the results
• Access Criteria: Study investigators. Other requests should be directed to the investigators.

Locations

BE (1)