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CompletedNCT05837741Updated May 9, 2023

Leucine-enriched Formulas in Patients With Tumor-induced Sarcopenia

An interventional study of Standard hypercaloric hyperproteic oral nutritional supplement and Leucine-enriched hypercaloric hyperproteic oral nutritional supplement in Sarcopenia and Cancer, sponsored by Maimónides Biomedical Research Institute of Córdoba. Completed at 1 site in Spain. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2023-05-09.

Sponsored by Maimónides Biomedical Research Institute of Córdoba · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 2 years 1 month after the study started (first participant enrolled Mar 2021, registered Apr 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
18 Years to 90 Years
Sex
All
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Study summary

Currently there is a lack of evidence for recommending specific oral supplements (OS) for nutritional support in patients with cancer, including leucine-enriched supplements.

Read the detailed description

Appropriate clinical trials that compare anthropometric and biochemical changes in nutritional parameters and clinical outcomes in patients with cancer-induced sarcopenia are required

02

Conditions studied

  • Sarcopenia
  • Cancer

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Keywords

  • Sarcopenia
  • Cancer
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In context

Sarcopenia

1,206 studies on the registry are indexed under Sarcopenia; 401 are open to participants now.

This study's enrollment of 48 is below the median of 60 across 773 interventional studies indexed under Sarcopenia.

Browse Sarcopenia studies →

Lead sponsor

Maimónides Biomedical Research Institute of Córdoba is the lead sponsor of 78 studies on the registry; 20 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • patients of both sexes, age > 18 y-old
  • cancer of different origin treated with systemic treatment chemo, radiotherapy or combination treatment t
  • weight loss >5% during the previous three months or >10% during the previous six months

Exclusion criteria

Exclusion Criteria:

  • end-stage kidney disease
  • life expectancy \< 2 weeks
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
48 participants (actual)

Study arms

  • Active comparator
    Standard hypercaloric, hyperproteic oral supplement

    Patients will receive 2 supplements per day (Standard hypercaloric, hyperproteic oral supplement)

    Dietary Supplement: Standard hypercaloric hyperproteic oral nutritional supplement

  • Active comparator
    Leucin-enriched hypercaloric, hyperproteic oral supplement

    Patients will receive 2 supplements per day (Leucin-enriched hypercaloric, hyperproteic oral supplement)

    Dietary Supplement: Leucine-enriched hypercaloric hyperproteic oral nutritional supplement

Interventions

  • Dietary supplementStandard hypercaloric hyperproteic oral nutritional supplement

    Patients will receive nutritional support with Standard hypercaloric hyperproteic oral nutritional supplement

  • Dietary supplementLeucine-enriched hypercaloric hyperproteic oral nutritional supplement

    Patients will receive nutritional support with Leucine-enriched hypercaloric hyperproteic oral nutritional supplement

06

What researchers measure

Primary outcomes

  1. Muscle mass gain

    Changes in Muscle mass (%) determined by BIA and echography

    Time frame: 3 Months

Secondary outcomes

  1. Fat mass change

    Changes in fast mass (%) determined by BIA and echography

    Time frame: 3 Months

  2. Phase angle change

    Changes in phase angle determined by BIA

    Time frame: 3 Months

  3. Changes in albumin

    Changes in serum albumin levels (g/dL)

    Time frame: 3 Months

  4. Changes in prealbumin

    Changes in serum prealbumin levels (mg/dL)

    Time frame: 3 Months

  5. Changes in CRP

    Changes in serum CRP levels (g/L)

    Time frame: 3 Months

07

Study locations

1 site
  • IMIBIC
    Córdoba, Cordoba 14004, Spain
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 9, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05837741
Lead sponsor
Maimónides Biomedical Research Institute of Córdoba
Responsible party
Aura Herrera (Principal Investigator, Maimónides Biomedical Research Institute of Córdoba) — Principal investigator
First posted
May 1, 2023
Start date
Mar 1, 2021
Primary completion
Aug 1, 2021
Completion
Nov 1, 2021
Last update
May 9, 2023

Study contacts

Aura D Herrera Martinez, PhD
principal investigator · IMIBIC-HURS

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.

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