NCT05318014

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
95

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 25, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2020

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 15, 2022

Completed
24 days until next milestone

First Posted

Study publicly available on registry

April 8, 2022

Completed
Last Updated

April 8, 2022

Status Verified

March 1, 2022

Enrollment Period

1.1 years

First QC Date

March 15, 2022

Last Update Submit

March 31, 2022

Conditions

Chronic Kidney Disease

Keywords

Oral nutrition supplementChronic kidney disease

Outcome Measures

Primary Outcomes (10)

  • Change of muscle strength

    Hand grip strength

    Baseline to 12 weeks and 24 weeks

  • Change of Gait speed

    Gait speed measurement

    Baseline to 12 weeks and 24 weeks

  • Change of 5-meter distance walk

    5-meter distance walk measurement

    Baseline to 12 weeks and 24 weeks

  • Change of nutrition status

    Mini Nutritional Assessment Short-Form score

    Baseline to 12 weeks and 24 weeks

  • Change of body composition

    Using bioelectrical impedance analysis(BIA, Tanita MC-780, Japan)

    Baseline to 12 weeks and 24 weeks

  • Change of total energy intake

    24-hour dietary record measurement

    Baseline to 12 weeks and 24 weeks

  • Change of protein intake

    24-hour dietary record measurement

    Baseline to 12 weeks and 24 weeks

  • Change of carbohydrate intake

    24-hour dietary record measurement

    Baseline to 12 weeks and 24 weeks

  • Change of fat intake

    24-hour dietary record measurement

    Baseline to 12 weeks and 24 weeks

  • Change of micronutrients intake

    24-hour dietary record measurement

    Baseline to 12 weeks and 24 weeks

Secondary Outcomes (21)

  • Change of serum creatinine

    Baseline to 12 weeks and 24 weeks

  • Change of blood urea nitrogen

    Baseline to 12 weeks and 24 weeks

  • Change of estimated glomerular filtration rate

    Baseline to 12 weeks and 24 weeks

  • Change of daily protein intake.

    Baseline to 12 weeks and 24 weeks

  • Change of albumin

    Baseline to 12 weeks and 24 weeks

  • +16 more secondary outcomes

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Dietary Supplement: Intervention group

Regular nutrition education

PLACEBO COMPARATOR

Regular nutrition education

Other: Regular nutrition education

Interventions

Intervention groupDIETARY_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

Intervention group
Regular nutrition educationOTHER

dietitian regular nutrition educataion which was following a low protein diet

Regular nutrition education

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taichung Verterans General Hospital Taichung

Taichung, Taiwan

Location

Related Publications (1)

  • Yang WC, Hsieh HM, Chen JP, Liu LC, Chen CH. Effects of a low-protein nutritional formula with dietary counseling in older adults with chronic kidney disease stages 3-5: a randomized controlled trial. BMC Nephrol. 2023 Dec 14;24(1):372. doi: 10.1186/s12882-023-03423-8.

    PMID: 38097963DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Cheng-Hsu Chen, MDPHD

    Division of Nephrology in Taichung Veterans General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 15, 2022

First Posted

April 8, 2022

Study Start

September 25, 2019

Primary Completion

October 31, 2020

Study Completion

December 31, 2021

Last Updated

April 8, 2022

Record last verified: 2022-03

Locations

TW(1)