The CONFUCIUS Oral Protein Supplementation Trial

NCT05405764 | Terminated

• 1 other identifier: NL7915809121
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Study the effect of 6-weeks porcine protein supplementation vs isocaloric comparator (carbohydrate) on functional outcomes in post ICU-patients. Patients will be included at ICU discharge. Included patients will receive the supplements twice daily (morning and afternoon), starting at the first day at the general ward. To the best of our knowledge, a study on protein supplementation in the post-ICU period to address its effect on functional outcomes is lacking.

Conditions

Intensive Care Unit Acquired Weakness; Critical Illness

Keywords

Functional outcomes; Proteins; Intensive care unit

Outcome Measures

Primary Outcomes (3)

• Between group difference in composite score over time. The composite score consists of handgrip strength, muscle strength leg, muscle strength arm and exercise capacity.

  Between-group difference in physical function over time expressed as a composite score. The composite score consists of handgrip strength, muscle strength leg, muscle strength arm and exercise capacity. Handgrip strength will be measured with the Jamar dynamometer Muscle strength leg will be measured with the handheld dynamometer m. quadriceps fem. Muscle strength arm will be measured with the handheld dynamometer bicepss brachii Exercise capacity will be measured with the 6 minute walking distance test. Measured values will be compared to normative data. Calculated percentages will be added up and together form the composite score.

  At hospital discharge, an average of 11 days

• Between group difference in composite score over time. The composite score consists of handgrip strength, muscle strength leg, muscle strength arm and exercise capacity.

  Between-group difference in physical function over time expressed as a composite score. The composite score consists of handgrip strength, muscle strength leg, muscle strength arm and exercise capacity. Handgrip strength will be measured with the Jamar dynamometer Muscle strength leg will be measured with the handheld dynamometer m. quadriceps fem. Muscle strength arm will be measured with the handheld dynamometer bicepss brachii Exercise capacity will be measured with the 6 minute walking distance test. Measured values will be compared to normative data. Calculated percentages will be added up and together form the composite score.

  At the end of the intervention = 6 weeks after ICU discharge

• Between group difference in composite score over time. The composite score consists of handgrip strength, muscle strength leg, muscle strength arm and exercise capacity.

  Between-group difference in physical function over time expressed as a composite score. The composite score consists of handgrip strength, muscle strength leg, muscle strength arm and exercise capacity. Handgrip strength will be measured with the Jamar dynamometer Muscle strength leg will be measured with the handheld dynamometer m. quadriceps fem. Muscle strength arm will be measured with the handheld dynamometer bicepss brachii Exercise capacity will be measured with the 6 minute walking distance test. Measured values will be compared to normative data. Calculated percentages will be added up and together form the composite score.

  At 3-months follow-up

Secondary Outcomes (14)

• Handgrip strength

  6 weeks after ICU discharge (end of the intervention)

• Muscle strength leg

  6 weeks after ICU discharge (end of the intervention)

• Muscle strength arm

  6 weeks after ICU discharge (end of the intervention)

• Exercise capacity

  6 weeks after ICU discharge (end of the intervention)

• Lower extremity muscle strength

  6 weeks after ICU discharge (end of the intervention)

Study Arms (2)

Porcine protein group

EXPERIMENTAL

The patients will receive protein supplements twice daily (2x22g) for a period of 6 weeks during breakfast and lunch. The supplement will be delivered in powdered form.

Dietary Supplement: Porcine protein supplement

Carbohydrate group

PLACEBO COMPARATOR

The patients will receive isocaloric carbohydrate supplements twice daily (2x21g) for a period of 6 weeks during morning and afternoon. The supplement will be delivered in powdered form.

Dietary Supplement: Control product maltodextrin supplement

Interventions

Porcine protein supplement DIETARY_SUPPLEMENT

Porcine protein supplementation

Porcine protein group

Control product maltodextrin supplement DIETARY_SUPPLEMENT

Maltodextrin supplementation

Carbohydrate group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Living at home before hospital admission
• Minimum ICU stay of 72 h
• Informed consent

You may not qualify if:

• MRC sum score ≤24 or 48≥ at ICU discharge
• Barthel Index \<14 before ICU admission
• Chronic home ventilation
• Mitochondrial or muscle disease or pareses
• Serum creatinine \> 173 mcmol/l (renal dysfunction)
• Treatment limitations: DNR, no ICU readmission or palliative care
• Intolerance or allergy (for study products)
• People living in a nursing home before hospital admission
• Chronic Organizing Pneumonia or Pulmonary Interstitial Fibrosis
• Inflammatory Bowel Disease
• Diabetes Mellitus pharmaceutical medication at ICU admission
• Underlying disease in which in the eyes of the attending physician, the protein or carbohydrate supplement could form a risk for the patient.
• Pregnancy

Sponsors & Collaborators

• ARH van Zanten: lead
• Intensive Care Research Foundation, Gelderse Vallei Hospital: collaborator
• Rousselot BVBA: collaborator

Study Sites (1)

Gelderse Vallei Hospital

Ede, Gelderland, 6716RP, Netherlands

Location

Related Publications (2)

• Paulus MC, Kouw IWK, Boelens YFN, Hermans AJH, Strookappe B, van Zanten ARH. Feasibility challenges in protein supplementation research: Insights from the convalescence of functional outcomes after intensive care unit stay in a Randomised Controlled Trial. Clin Nutr. 2025 Mar;46:119-130. doi: 10.1016/j.clnu.2025.01.020. Epub 2025 Jan 21.

  PMID: 39914233 DERIVED

• Boelens YF, Strookappe B, Vasse E, Mensink M, van Zanten AR. The effect of an intervention of porcine protein versus maltodextrin supplement on CONvalescence of FUnCtional outcomes after IcU Stay (CONFUCIUS): Study protocol for a randomized controlled, single-center, double-blind trial. Clin Nutr ESPEN. 2022 Dec;52:86-93. doi: 10.1016/j.clnesp.2022.10.008. Epub 2022 Oct 19.

  PMID: 36513490 DERIVED

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Arthur RH van Zanten, MD, PhD

  Gelderse Vallei Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Identical non-transparent sachets with circle or square
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr. ARH van Zanten, MD, PhD

Model Details: parallel two-arm randomized blinded controlled trial

Study Record Dates

• First Submitted: April 13, 2022
• First Posted: June 6, 2022
• Study Start: April 19, 2022
• Primary Completion: September 24, 2024
• Study Completion: September 24, 2024
• Last Updated: September 25, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)