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NCT06076187 Clinical Trial

The Proportion of Dietary Protein Digested as Measured by the Dual-isotope Method.

Aging Clinical Trial

Official title:
The Proportion of Dietary Protein Digested as Measured by the Dual-isotope Method.

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06076187
Other study ID # S67116
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 1, 2023
Est. completion date May 1, 2024

Study information
Verified date April 2023
Source Universitaire Ziekenhuizen KU Leuven
Contact Nele Steenackers
Phone +16344913
Email nele.steenackers@kuleuven.be
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The retrospective cohort study will compare the prevalence of sarcopenia and associated factors between older patients who have undergone bariatric surgery and older patients with obesity without previous bariatric surgery.

Description:

The aim of the study is to compare the prevalence of sarcopenia and nutritional status between adults older than 65 years who have previously undergone bariatric surgery and patients with obesity but without previous bariatric surgery. Current sarcopenia will be assessed during a cross-sectional assessment after surgery using the criteria from the European Working Group on Sarcopenia in Older People (EWGSOP).

Recruitment information / eligibility
Status Recruiting
Enrollment 30
Est. completion date May 1, 2024
Est. primary completion date May 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years and older
Eligibility Inclusion Criteria: - Signed informed consent - Age 65 years or older - Group 1 & 2: Previous bariatric surgery for obesity 1 - 10 years ago - Group 3: 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Dual isotope method
Dual isotope method

Locations
Country Name City State
Belgium UZLeuven Leuven Vlaams Brabant

Sponsors (1)
Lead Sponsor Collaborator
Universitaire Ziekenhuizen KU Leuven

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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