Low-protein Formula Supplements in Chronic Kidney Disease

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

COMPLETED

Clinical Phase

NA

Total Enrollment

95 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-25

Study Completion Date

2021-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Chronic Kidney Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention group

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

Group Type EXPERIMENTAL

Intervention group

Intervention Type DIETARY_SUPPLEMENT

dietitian regular nutrition education which was following a low protein diet and supply one serving per day of 6 % low protein formula (200mL,2kcal/ml) for 24 weeks

Regular nutrition education

Group Type PLACEBO_COMPARATOR

Regular nutrition education

Intervention Type OTHER

dietitian regular nutrition educataion which was following a low protein diet

Interventions

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Intervention group

dietitian regular nutrition education which was following a low protein diet and supply one serving per day of 6 % low protein formula (200mL,2kcal/ml) for 24 weeks

Intervention Type DIETARY_SUPPLEMENT

Regular nutrition education

dietitian regular nutrition educataion which was following a low protein diet

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No