An interventional study of Tality in Prostate Cancer, sponsored by Stanford University. Completed at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-28.
Sponsored by Stanford University · Not applicable, Interventional, and Supportive care
This study will find out if a meal replacement of this type is satisfying and tolerable for men with prostate cancer. Participants will receive meal replacements of TalityTM as their expected sole source of nutrition for 4 weeks. The purpose of the study is to test whether TalityTM Synthetic Meal Replacements are suitable to be used in larger studies of patients with prostate or other types of cancer.
Primary Objective: Determine the appeal/tolerability/palatability of a diet consisting solely of TalityTM synthetic meal replacement in participants with prostate cancer Secondary Objective: Evaluate the effect of TalityTM on safety parameters including laboratory tests, nutritional status and adverse effects
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's enrollment of 16 is below the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Stanford University is the lead sponsor of 2,117 studies on the registry; 425 are open to participants now.
Of its 259 completed or terminated interventional studies of FDA-regulated products, 197 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will receive TalityTM as their sole intake for nutritional purposes for a 4 week period.
Other: Tality
Synthetic meal replacements, delivered in many varieties of 400 kCal packets, Manufacturer: Filtricine, Inc.
Proportion of Completers
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).
Time frame: 4 weeks
Change in weight from baseline
Change in weight will be measured from baseline.
Time frame: 4 weeks
Change in amino acid levels
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.
Time frame: 4 weeks
Change in Prostate Specific Antigen
Change from baseline in the serum level of prostate specific antigen (PSA).
Time frame: 4 weeks
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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Stanford University