Low-protein Formula Supplements in Chronic Kidney Disease

Taichung Veterans General Hospital

Status: Completed

Conditions: Chronic Kidney Disease

Treatments: Dietary Supplement: Intervention group; Other: Regular nutrition education

Study type: Interventional

Funder types: Other

Identifiers

NCT05318014

CF19237B

Details and patient eligibility

About

Prospective randomized contorl study.Comparing clinical outcome between chronic kidney disease who were prescribed 6% low-protein nutrition supplement along with dietatian regular nutrition education and those without oral nutrition supplement.

Full description

Past studies have shown that supplementation with low-protein nutritional formulas helps to increase compliance with low-protein diet control, but few studies have explored low-protein nutritional formulas supplementing the calories chronic kidney disease patient need, and nutritional supplements rich in ω-3 fatty acids, vitamin D and essential amino acid having effect in chronic renal function and changes in muscle mass, strength, and mobility. The propose of this study that low protein supplement may help maintain renal function or delay deterioration of renal function, or may reduce the risk of malnutrition and further improve muscle strength and mobility or quality of life.

Enrollment: 95 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Subject is >65years of age.
2. Subject has been diagnosed with Chronic Kidney Disease (CKD) and is classified as being between Stages 3 to 5.

Exclusion criteria

1. The physician determines that the clinical condition is unstable.
2. Lower limb injury or severe edema.
3. food allergies to milk, or fish
4. There is a heart rhythm in the body and a prosthetic device.
5. Those who are unable to complete the questionnaire due to severe cognitive impairment as determined by the physician.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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95 participants in 2 patient groups, including a placebo group

Intervention group

Experimental group

Description:

Regular nutrition education and supply one serving per day of 6% low protein formula.

Treatment:

Dietary Supplement: Intervention group

Regular nutrition education

Placebo Comparator group

Description:

Regular nutrition education

Treatment:

Other: Regular nutrition education