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NCT01412658 · ClinicalTrials.gov registry record · Phase 1
Clinical Safety of a Novel Milk Protein Peptide
A Phase 1 study of Drug Safety, sponsored by Ambryx Biotechnology.
- Completed
- Registry status
- Phase 1
- Development phase
- 73
- Enrollment target
- 1
- Study location
NCT01412658: Completed Phase 1 study of Drug Safety, sponsored by Ambryx Biotechnology.
NCT01412658 is a Phase 1 study of Drug Safety that has completed, run by Ambryx Biotechnology. The registered enrollment target is 73 participants, below the 86-participant average among 4 other Drug Safety trials with a reported enrollment target (15% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01412658, a Phase 1 study of Drug Safety, has completed, sponsored by Ambryx Biotechnology.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 73 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: A novel milk peptide has been shown in laboratory setting to have natural anti-cancer properties and extend lifespan and improve metabolism in animal models. The purpose of this study was 1.) to determine the safety dosage range and, 2.) to determine whether this novel milk peptide positively influence blood markers, metabolism and improve quality of life.
Primary Outcome
General whole blood and serum clinical chemistries (cholesterol, triglycerides, glucose, blood urea nitrogen, creatinine, uric acid, muscle and liver enzymes) and hormones (insulin, homeostasis model of insulin sensitivity, and leptin).
Conditions Studied
Interventions
- DIETARY_SUPPLEMENT Hydrolyzed milk protein mixture
- DIETARY_SUPPLEMENT Glycerol placebo
Study Locations (1)
Texas
- Baylor University Center for Exercise, Nutrition, and Preventive Health Research - Waco
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 73 participants |
| Start Date | 2006-11 |
| Est. Completion | 2007-02 |
| Phase | Phase 1 |
What the finished NCT01412658 record still lists
NCT01412658 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 73 participants, a relatively small participant target, below the 86-participant average among 4 other Drug Safety trials with a reported enrollment target (15% lower).
The record links to 1 condition, with Drug Safety appearing as the primary indexed condition, and to 2 interventions - of which Hydrolyzed milk protein mixture is the first listed.
NCT01412658 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT01412658 about?
NCT01412658 is a clinical study titled "Clinical Safety of a Novel Milk Protein Peptide". Background: A novel milk peptide has been shown in laboratory setting to have natural anti-cancer properties and extend lifespan and improve metabolism in animal models. The purpose of this study was 1.) to determine the safety dosage range and, 2.) to determine whether this novel milk peptide posit...
What is the current status of trial NCT01412658?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 73 participants. The study started on 2006-11. Estimated completion is 2007-02.
What conditions does trial NCT01412658 study?
This clinical trial studies the following conditions: Drug Safety.
What interventions are being tested in trial NCT01412658?
The interventions under investigation include: Hydrolyzed milk protein mixture (DIETARY_SUPPLEMENT), Glycerol placebo (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT01412658?
This trial is sponsored by Ambryx Biotechnology, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01412658 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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