NCT05333692

Brief Summary

This study is aimed to demonstrate that increase in serum albumin concentration (week 8 -baseline) after test treatment (Fresubin® Protein Energy DRINK), a standard ONS, is not relevantly smaller than that after control treatment with NEPRO®.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2020

Shorter than P25 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

July 1, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 6, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 6, 2021

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

April 7, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 19, 2022

Completed
Last Updated

April 19, 2022

Status Verified

April 1, 2022

Enrollment Period

10 months

First QC Date

April 7, 2022

Last Update Submit

April 17, 2022

Conditions

Hemodialysis Complication

Outcome Measures

Primary Outcomes (1)

  • Serum Albumin level change

    baseline, weerk 4 and week 8

Secondary Outcomes (1)

  • Body Weight (kg) and Height(cm) change, and these results will be combine to report BMI (kg/m^2) change

    baseline, weerk 4 and week 8

Study Arms (2)

NEPRO®

ACTIVE COMPARATOR
Dietary Supplement: NEPRO® , Abbott

Fresubin® Protein Energy DRINK

EXPERIMENTAL
Dietary Supplement: Fresubin® Protein Energy DRINK

Interventions

Fresubin® Protein Energy DRINKDIETARY_SUPPLEMENT

1-2 bottles of Fresubin® Protein Energy DRINK per day

Fresubin® Protein Energy DRINK
NEPRO® , AbbottDIETARY_SUPPLEMENT

2-4 cans NEPRO® per day

NEPRO®

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 40-80 years
  • Acute or chronic renal failure patients who need dialysis and already dialysis for 3 months at least.
  • Malnutrition patients. Definition of Malnutrition is serum albumin level\<3.5g/dL, calorie digestion below 35kcal/IBW or protein digestion below 1.2g/IBW.

You may not qualify if:

  • BMI\<18.5 and calorie intake unable to reach 50% of the recommended level
  • BMI\>30 kg/m2,
  • abnormal liver function,
  • malignant disease,
  • scheduled surgery within a month or after surgery,
  • infectious disease,
  • suboptimal tolerance of nutritional supplements,
  • inflammatory bowel disease, bowel obstruction,
  • acute condition complicated with multiple organ failure or under palliative care.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chung Shan Medical University

Taichung, 40201, Taiwan

Location

Study Design

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

Study Record Dates

First Submitted

April 7, 2022

First Posted

April 19, 2022

Study Start

July 1, 2020

Primary Completion

May 6, 2021

Study Completion

May 6, 2021

Last Updated

April 19, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)