Brain HealthNCT02439983
Brain Imaging Study
A study testing Proprietary Nutritional Supplement in people with Brain Health, run by Pharmanex at 1 site in United States.
Trial summary
The study is designed to evaluate the effects of the proprietary nutritional supplement on cognition, mood, and brain imaging parameters following a relatively short period of treatment. Read more about this study
- Who is it for?
- Ages 40 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Brain Health
- What is being tested?
- Proprietary Nutritional Supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2015to Jun 2016
- Phase
- Interventional
- 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 40 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Both male and female subjects will be included.
- Age between 40-60 years inclusive.
- Healthy subjects who, in the opinion of the investigator, are free of any medical conditions that might affect study measures.
- Eats 1 or fewer servings of fatty fish per week.
- BMI < 35
Who cannot join
- Current or past neurological illness.
- Substance abuse or dependence within the prior 60 days.
- Current depression (HAMD greater than 20) or anxiety disorder (HAMA greater than 18).
- Current or past history of psychiatric disorder.
- History of head trauma with loss of consciousness.
- Contraindication to brain MRI examination.
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- Supplementation with Omega 3, fish oil, or other over the counter supplements including the other bioactive ingredients in the proprietary nutritional supplement, antioxidants and multi-vitamin mineral supplements for the previous 3 months.
- Plasma Omega3 Index >5% at screening visit.
- Subject has a known allergy or intolerance to any of the ingredients contained in the proprietary nutritional supplement or placebo.
- Subject is currently pregnant, planning to become pregnant, or is breastfeeding.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Utah - Brain Institute
Salt Lake City, Utah, 84108
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Study Investigating the Effects of a Proprietary Nutritional Supplement on Brain Health
The study is designed to evaluate the effects of the proprietary nutritional supplement on cognition, mood, and brain imaging parameters following a relatively short period of treatment.
- Conditions
- Brain Health
- Being tested
- Proprietary Nutritional Supplement, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proprietary Nutritional SupplementDietary supplement
2 capsules taken by mouth with morning and evening meals.
PlaceboDietary supplement
2 capsules taken by mouth with morning and evening meals.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
| Proprietary Nutritional Supplement | Experimental | Not described Receives: Dietary Supplement: Proprietary Nutritional Supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in MRI Brain scan
Determine differences in brain metabolism, brain connectivity, or brain structure. Highlight regional brain changes between pre and post chronic supplementation with a proprietary nutritional formula.
Measured: Change from Baseline MRI Brain scan at Day 42
Secondary outcomes (9)
Change in anxiety as measured by the Hamilton Anxiety Scale (HAM-A)
Measured: Change from Baseline anxiety at Day 42
Change in depression as measured by the Hamilton Depression Rating Scale (HAM-D)
Measured: Change from Baseline depression at Day 42
Change in mood as measured by the Profile of Mood States (POMS)
Measured: Change from Baseline mood at Day 42
Change in memory as measured by Logical Memory I and II (subtests from the Wechsler Memory Scale- IV)
Measured: Change from Baseline memory at Day 42
Change in fluency as measure by Letter and Category Fluency test
Measured: Change from Baseline fluency at Day 42
Change in Chemistry panel
Measured: Change from Baseline Chemistry panel at Day 42
Change in RBC fatty acid profile
Measured: Change from Baseline RBC fatty acid profile at Day 42
Change in Gene expression
Measured: Change from Baseline Gene expression at Day 42
Measurement of polyphenol metabolites in saliva
Measured: Day 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2015 (estimated)
- Study startApr 2015
- Primary completionJun 2016
- Study completionJun 2016
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 Brain HealthStudies 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 N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pharmanex
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Utah
- Responsible party
- Sponsor
- Investigators
- Deborah Yurgelun-Todd, Ph.D., Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02439983
- Sponsor's protocol ID
- 14-PHX-0002
- Status last verified
- Aug 2016
- First submitted
- 30 Apr 2015
- Last updated
- 3 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Mastaloudis A, Sheth C, Hester SN, Wood SM, Prescot A, McGlade E, Renshaw PF, Yurgelun-Todd DA. Supplementation with a putative calorie restriction mimetic micronutrient blend increases glutathione concentrations and improves neuroenergetics in brain of healthy middle-aged men and women. Free Radic Biol Med. 2020 Jun;153:112-121. doi: 10.1016/j.freeradbiomed.2020.04.017. Epub 2020 Apr 23.
PubMed 32335159
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Study Investigating the Effects of a Proprietary Nutritional Supplement on Brain Health
- ClinicalTrials.gov ID
- NCT02439983
- Acronym / sponsor ID
- 14-PHX-0002
- Conditions
- Brain Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- PharmanexIndustry (pharma, biotech, devices)
- Collaborators
- University of Utah
- Study start
- Apr 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 12 May 2015 (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.
The study is designed to evaluate the effects of the proprietary nutritional supplement on cognition, mood, and brain imaging parameters following a relatively short period of treatment.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
| Proprietary Nutritional Supplement | Experimental | Dietary Supplement: Proprietary Nutritional Supplement |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Both male and female subjects will be included.
- Age between 40-60 years inclusive.
- Healthy subjects who, in the opinion of the investigator, are free of any medical conditions that might affect study measures.
- Eats 1 or fewer servings of fatty fish per week.
- BMI < 35
Key exclusion criteria (10 listed)
- Current or past neurological illness.
- Substance abuse or dependence within the prior 60 days.
- Current depression (HAMD greater than 20) or anxiety disorder (HAMA greater than 18).
- Current or past history of psychiatric disorder.
- History of head trauma with loss of consciousness.
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 |
|---|---|---|
| Proprietary Nutritional Supplement2 capsules taken by mouth with morning and evening meals. | Dietary supplement | Proprietary Nutritional Supplement |
| Placebo2 capsules taken by mouth with morning and evening meals. | Dietary supplement | Placebo |
Primary outcome
Change in MRI Brain scan
Time frame: Change from Baseline MRI Brain scan at Day 42
Determine differences in brain metabolism, brain connectivity, or brain structure. Highlight regional brain changes between pre and post chronic supplementation with a proprietary nutritional formula.
9 secondary outcomes
Change in anxiety as measured by the Hamilton Anxiety Scale (HAM-A)
Time frame: Change from Baseline anxiety at Day 42
Change in depression as measured by the Hamilton Depression Rating Scale (HAM-D)
Time frame: Change from Baseline depression at Day 42
Change in mood as measured by the Profile of Mood States (POMS)
Time frame: Change from Baseline mood at Day 42
Change in memory as measured by Logical Memory I and II (subtests from the Wechsler Memory Scale- IV)
Time frame: Change from Baseline memory at Day 42
Change in fluency as measure by Letter and Category Fluency test
Time frame: Change from Baseline fluency at Day 42
Change in Chemistry panel
Time frame: Change from Baseline Chemistry panel at Day 42
Change in RBC fatty acid profile
Time frame: Change from Baseline RBC fatty acid profile at Day 42
Change in Gene expression
Time frame: Change from Baseline Gene expression at Day 42
Measurement of polyphenol metabolites in saliva
Time frame: Day 42
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 3 Aug 2016.
- Derived from this study: PubMed 32335159Mastaloudis A, Sheth C, Hester SN, Wood SM, Prescot A, McGlade E, Renshaw PF, Yurgelun-Todd DA. Supplementation with a putative calorie restriction mimetic micronutrient blend increases glutathione concentrations and improves neuroenergetics in brain of healthy middle-aged men and women. Free Radic Biol Med. 2020 Jun;153:112-121. doi: 10.1016/j.freeradbiomed.2020.04.017. Epub 2020 Apr 23.
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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.
Deborah Yurgelun-Todd, Ph.D. principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Proprietary Nutritional Supplement in people with Brain Health, run by Pharmanex 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 5 inclusion and 10 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 3 Aug 2016. 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.
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?
Change in MRI Brain scan (time frame: Change from Baseline MRI Brain scan at Day 42). 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 NCT02439983, 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 3 Aug 2016.