Skip to content

Protein Needs Study

Innovative Approaches to the Lack of Evidence-based Dietary Protein Requirements for Patients With Cancer

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04144907
Enrollment
40
Registered
2019-10-30
Start date
2021-04-26
Completion date
2030-09-30
Last updated
2026-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Colorectal Cancer

Brief summary

Severe muscle loss in patients with cancer has been associated with increased physical disability, extended hospitalization, infectious and noninfectious complications, increased risk of severe toxicity during cancer treatment, poor quality of life and shortened survival. Adequate protein is key to sustain muscle mass and overall health. However, current nutritional recommendations are not specific or evidence-based. The aim of this project is to determine the protein needs of patients with colorectal or breast cancer. Protein needs will be determined using a novel, non-invasive approach. Our results will inform nutritional recommendations and guidelines with the ultimate goal of improving outcomes for people with cancer.

Interventions

DIETARY_SUPPLEMENTPhenylalanine intake

Oral consumption of eight hourly experimental meals- Includes 4 tracer-free experimental meals containing a mixture of free amino acids, calories from a flavored liquid and protein-free cookies and 4 labeled amino acid experimental meals.

Sponsors

University of Alberta
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
45 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* Outpatients age 45-80 years; * Patients attending the new patient clinic at the Cross Cancer Institute with a diagnosis of colorectal cancer or breast cancer (stages II to III); * Able to complete baseline visits within approximately 4 weeks of starting chemotherapy OR after a minimum of 4 weeks post-surgery if not undergoing chemotherapy; * Ambulatory.

Exclusion criteria

* Premenopausal women due to impact on protein requirements; * Received anti-cancer hormone treatment or immunotherapy in the 4 weeks before first baseline visit; * Renal impairment based on a creatinine clearance for estimated glomerular filtration rate (eGFR) of \<60 mL/min * Abnormal glucose metabolism based on a fasting glucose level \>6mmol/L and an HbA1c \>5.7% or as reviewed by study team; * Comorbidities or medications that would interfere with the participants ability to follow the study protocol or the quality of the data(e.g. diabetes, class III obesity, hormone therapy, another active cancer diagnosis); * Unable/unwilling to provide urine, breath and blood samples (e.g. oxygen tank, catheter, etc.); * Unable to eat the meals provided (i.e. receiving parenteral or enteral nutrition, severe allergies); * Substance dependent (e.g. alcohol, cigarettes, illicit drugs) and unable to follow study protocols.

Design outcomes

Primary

MeasureTime frameDescription
13C Phenylalanine Oxidation8.5 hoursBreath, urine and blood samples will be collected during the study to measure the rate of oxidation of 13C phenylalanine.

Countries

Canada

Contacts

CONTACTAnne Caretero, RD
caretero@ualberta.ca780-492-7820
PRINCIPAL_INVESTIGATORCarla Prado, PhD, RD

University of Alberta

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 13, 2026