Tolerability/Palatability of TalityTM Synthetic Meal Replacement in Prostate Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04389918|
Recruitment Status : Recruiting
First Posted : May 15, 2020
Last Update Posted : March 4, 2022
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Other: Tality||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||A Phase I Study of the Tolerability/Palatability of TalityTM Synthetic Meal Replacement in Patients With Prostate Cancer|
|Actual Study Start Date :||October 26, 2020|
|Estimated Primary Completion Date :||December 2022|
|Estimated Study Completion Date :||March 2023|
Participants will receive TalityTM as their sole intake for nutritional purposes for a 4 week period.
Synthetic meal replacements, delivered in many varieties of 400 kCal packets, Manufacturer: Filtricine, Inc.
- Proportion of Completers [ Time Frame: 4 weeks ]The proportion of participants who complete the 4 week study using TalityTM as their sole source of nutrition at a high level of adherence (75% of days, 21+ days out of the 28 day study).
- Change in weight from baseline [ Time Frame: 4 weeks ]Change in weight will be measured from baseline.
- Change in amino acid levels [ Time Frame: 4 weeks ]Change in amino acid levels as compared to baseline will be measured. The following amino acids will be analyzed a-Aminoadipic Acid, a-Aminobutyric Acid, Alanine, Arginine, Asparagine, Aspartic Acid, b-Alanine, b-Aminoisobutyric Acid, Citrulline, Cystathionine, Cystine, Ethanolamine, Glutamic Acid, Glutamine, Glycine, Histidine, Homocystine, Hydroxyproline, Isoleucine, Leucine, Lysine, Methionine, Ornithine, Phenylalanine, Proline, Sarcosine, Serine, Taurine, Threonine, Tryptophan, Tyrosine, Valine. It will be measured in micro-moles per Liter.
- Change in Prostate Specific Antigen [ Time Frame: 4 weeks ]Change from baseline in the serum level of prostate specific antigen (PSA).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04389918
|Contact: Deirdre Crommiefirstname.lastname@example.org|
|United States, California|
|Stanford, California, United States, 94304|
|Contact: Deirdre Crommie 650-387-7797 email@example.com|
|Principal Investigator: Randall S Stafford, MD, PhD|
|Principal Investigator:||Randall S Stafford, MD, PhD||Stanford Universiy|