Drug SafetyPhase 1NCT01412658
Clinical Safety of a Novel Milk Protein Peptide
A Phase 1 study testing Hydrolyzed milk protein mixture in people with Drug Safety, run by Ambryx Biotechnology at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 35 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Drug Safety
- What is being tested?
- Hydrolyzed milk protein mixture
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 73 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2006to Feb 2007
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subjects with body mass index between 27-40.
Who cannot join
- have any metabolic disorders including known electrolyte abnormalities, heart disease, arrhythmias, diabetes, thyroid disease or hypogonadism; a history of hypertension, hepatorenal, musculoskeletal, autoimmune, or neurologic disease; if they are taking thyroid, hyperlipidemic, hypoglycemic, anti-hypertensive, or androgenic medications;
- have milk allergies
Trial locations and contacts
1 site in 1 country.
United States1 site
Baylor University Center for Exercise, Nutrition, and Preventive Health Research
Waco, Texas, 76706
About this study
Official title: Safety Study of Milk Peptide Supplementation in Healthy Volunteers: a Randomized Placebo Controlled Clinical Trial
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.
Read the detailed description
The study was conducted as a randomized, double-blind, placebo-controlled clinical trial in a university research setting. Healthy volunteers were randomly assigned to ingest in a double-blind and randomized manner either a placebo or milk peptides. Outcome measures were assessed at 0, 3, and 6 weeks of supplementation.
- Conditions
- Drug Safety
- Being tested
- Hydrolyzed milk protein mixture, Glycerol placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydrolyzed milk protein mixtureDietary supplement
Also called AX-4
Take twice a day, dosage 6 ml-21 ml based on weight, mix with 1/2 cup of milk.
Glycerol placeboDietary supplement
Participants ingested 6ml-21ml of placebo mixed with 1/2 cup milk twice daily. The supplements were prepared in liquid form and packaged in generic bottles for double blind administration. The placebo was a starch-based placebo matched for color, texture, and taste to the active supplement.
A food diary is maintained daily.
| Study group | Role | What they receive |
|---|---|---|
| Milk Peptides | Experimental | Not described Receives: Dietary Supplement: Hydrolyzed milk protein mixture |
| Placebo | Placebo comparator | Participants ingested 6ml - 21ml (based on participants' weight) of clear, sugar-less liquid placebo mixed with 1/2 cup milk twice daily (once immediately after breakfast and once immediately after dinner). The supplements were prepared in liquid form and packaged in generic bottles for double blind administration. The placebo was a glycerol-based placebo matched for color, texture, and taste to the active supplement. Receives: Dietary Supplement: Glycerol placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood and Hormones
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).
Measured: 6 weeks
Secondary outcomes (2)
Psychosocial
quality of life indices
Measured: 6 weeks
Body Composition
All participants were tested for changes in energy intake and body composition
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2011 (estimated)
- Study startNov 2006
- Primary completionJan 2007
- Study completionFeb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Drug SafetyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ambryx Biotechnology
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Texas A&M University, Baylor University
- Investigators
- Rick Kreider, PhD, Principal investigator, Texas A&M University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01412658
- Sponsor's protocol ID
- AX_Safety_study
- Status last verified
- Aug 2011
- First submitted
- 7 Aug 2011
- Last updated
- 9 Aug 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kreider RB, Iosia M, Cooke M, Hudson G, Rasmussen C, Chen H, Mollstedt O, Tsai MH. Bioactive properties and clinical safety of a novel milk protein peptide. Nutr J. 2011 Sep 26;10:99. doi: 10.1186/1475-2891-10-99.
PubMed 21943352
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety Study of Milk Peptide Supplementation in Healthy Volunteers: a Randomized Placebo Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT01412658
- Acronym / sponsor ID
- AX_Safety_study
- Conditions
- Drug Safety
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Ambryx BiotechnologyIndustry (pharma, biotech, devices)
- Collaborators
- Texas A&M University, Baylor University
- Study start
- Nov 2006
- Primary completion
- Jan 2007 (actual)
- Study completion
- Feb 2007 (actual)
- First posted
- 9 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study was conducted as a randomized, double-blind, placebo-controlled clinical trial in a university research setting. Healthy volunteers were randomly assigned to ingest in a double-blind and randomized manner either a placebo or milk peptides. Outcome measures were assessed at 0, 3, and 6 weeks of supplementation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Milk Peptides | Experimental | Dietary Supplement: Hydrolyzed milk protein mixture |
| Placebo | Placebo comparator | Dietary Supplement: Glycerol placeboParticipants ingested 6ml - 21ml (based on participants' weight) of clear, sugar-less liquid placebo mixed with 1/2 cup milk twice daily (once immediately after breakfast and once immediately after dinner). The supplements were prepared in liquid form and packaged in generic bottles for double blind administration. The placebo was a glycerol-based placebo matched for color, texture, and taste to the active supplement. |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy subjects with body mass index between 27-40.
Key exclusion criteria (2 listed)
- have any metabolic disorders including known electrolyte abnormalities, heart disease, arrhythmias, diabetes, thyroid disease or hypogonadism; a history of hypertension, hepatorenal, musculoskeletal, autoimmune, or neurologic disease; if they are taking thyroid, hyperlipidemic, hypoglycemic, anti-hypertensive, or androgenic medications;
- have milk allergies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydrolyzed milk protein mixtureAlso: AX-4Take twice a day, dosage 6 ml-21 ml based on weight, mix with 1/2 cup of milk. | Dietary supplement | Milk Peptides |
| Glycerol placeboParticipants ingested 6ml-21ml of placebo mixed with 1/2 cup milk twice daily. The supplements were prepared in liquid form and packaged in generic bottles for double blind administration. The placebo was a starch-based placebo matched for color, texture, and taste to the active supplement. A food diary is maintained daily. | Dietary supplement | Placebo |
Primary outcome
Blood and Hormones
Time frame: 6 weeks
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).
2 secondary outcomes
Psychosocial
Time frame: 6 weeks
Body Composition
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2011.
- Derived from this study: PubMed 21943352Kreider RB, Iosia M, Cooke M, Hudson G, Rasmussen C, Chen H, Mollstedt O, Tsai MH. Bioactive properties and clinical safety of a novel milk protein peptide. Nutr J. 2011 Sep 26;10:99. doi: 10.1186/1475-2891-10-99.
- Exercise \& Sport Nutrition LabLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rick Kreider, PhD principal investigator
Texas A&M University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Hydrolyzed milk protein mixture in people with Drug Safety, run by Ambryx Biotechnology at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood and Hormones (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01412658, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2011.