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Protein Needs Study

NCT ID: NCT04144907

Last Updated: 2024-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-26

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Colorectal Cancer Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Phenylalanine intake

Group Type EXPERIMENTAL

Phenylalanine intake

Intervention Type DIETARY_SUPPLEMENT

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.

Interventions

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Phenylalanine 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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

45 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Alberta

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Carla Prado, PhD, RD

Role: PRINCIPAL_INVESTIGATOR

University of Alberta

Locations

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University of Alberta

Edmonton, Alberta, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Anne Caretero, RD

Role: CONTACT

Phone: 780-492-7820

Email: [email protected]

Facility Contacts

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Anne Caretero, RD

Role: primary

Other Identifiers

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HREBA.CC-19-0354

Identifier Type: -

Identifier Source: org_study_id