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Dietary Protein for Colorectal Cancer (PRIMe Trial)

N/A

Waitlist Available

Led By Carla Prado

Research Sponsored by University of Alberta

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, week 12

Awards & highlights

PRIMe Trial Summary

This trial will test whether different diets can help cancer patients maintain muscle and physical function.

Eligible Conditions

Colorectal Cancer

PRIMe Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, week 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, week 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change/maintenance in muscle mass

Secondary outcome measures

Change in physical function

PRIMe Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: High Protein DietExperimental Treatment2 Interventions

In the high protein diet, participants will be instructed to follow a diet that will provide them with the amount of calories enough to meet their energy needs without changing their body weight and will contain 2 g of protein per kilogram of body weight. Participants will be instructed to consume protein primarily from animal food sources. A high quality whey protein supplement will be provided as needed.

Group II: Normal Protein DietActive Control2 Interventions

In the normal protein diet, participants will be instructed to follow a diet that will provide them with the amount of calories enough to meet their energy needs without changing their body weight and will contain 1 g of protein per kilogram of body weight. Participants will be instructed to consume protein primarily from animal food sources. A high quality whey protein supplement will be provided as needed.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dietary counselling

2016

N/A

~400

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

OlymelUNKNOWN

University of AlbertaLead Sponsor

886 Previous Clinical Trials

384,778 Total Patients Enrolled

Canada Foundation for InnovationOTHER

7 Previous Clinical Trials

8,311 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the cohort of this experiment restricted to those aged 70 or younger?

"According to this trial's specifications, potential participants must be at least 18 years of age and no older than 85."

Answered by AI

Are there any slots available for participants of this trial?

"Although initially posted in April 2016, the clinicaltrials.gov page reveals that this study is no longer enrolling participants. However, 1064 other medical trials are actively recruiting at present."

Answered by AI

Is there a possibility I could participate in this research project?

"This medical study is searching for 50 participants with colorectal carcinoma, aged between 18 and 85. Subsequently, patients must have a life expectancy of at least one year and be able to complete all baseline assessments within two weeks of beginning chemotherapy or chemoradiotherapy (where applicable). Furthermore, they should possess adequate hepatic as well as renal functions that can be examined by their oncologist."

Answered by AI

Recent research and studies

Proceedings of the Nutrition SocietyJournal

Sarcopenia and Cachexia in the Era of Obesity: Clinical and Nutritional Impact

Prado, C. M., S. J. Cushen, C. E. Orsso, and A. M. Ryan. 2016. “Sarcopenia and Cachexia in the Era of Obesity: Clinical and Nutritional Impact”. Proceedings of the Nutrition Society. Cambridge University Press (CUP). doi:10.1017/s0029665115004279.

The Lancet OncologyJournal

Prevalence and Clinical Implications of Sarcopenic Obesity in Patients with Solid Tumours of the Respiratory and Gastrointestinal Tracts: A Population-based Study

Prado, Carla MM, Jessica R Lieffers, Linda J McCargar, Tony Reiman, Michael B Sawyer, Lisa Martin, and Vickie E Baracos. 2008. “Prevalence and Clinical Implications of Sarcopenic Obesity in Patients with Solid Tumours of the Respiratory and Gastrointestinal Tracts: A Population-based Study”. The Lancet Oncology. Elsevier BV. doi:10.1016/s1470-2045(08)70153-0.

Canadian Journal of Dietetic Practice and ResearchJournal

Dietary Patterns of Patients: With Advanced Lung or Colorectal Cancer

Prado, Carla M. M., PhD, Jessica R. Lieffers MSc, RD, Gabriella Bergsten RD, Marina Mourtzakis PhD, Vickie E. Baracos PhD, Tony Reiman MD, SM, FR, Michael B. Sawyer MD, BSc Ph, and Linda J. McCargar PhD, RD. 2012. “Dietary Patterns of Patients: With Advanced Lung or Colorectal Cancer”. Canadian Journal of Dietetic Practice and Research. Dietitians of Canada. doi:10.3148/73.4.2012.e298.

Canadian Journal of Dietetic Practice and ResearchJournal