NCT02439983

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

April 30, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 12, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

August 3, 2016

Status Verified

August 1, 2016

Enrollment Period

1.2 years

First QC Date

April 30, 2015

Last Update Submit

August 2, 2016

Conditions

Brain Health

Outcome Measures

Primary Outcomes (1)

  • 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.

    Change from Baseline MRI Brain scan at Day 42

Secondary Outcomes (9)

  • Change in anxiety as measured by the Hamilton Anxiety Scale (HAM-A)

    Change from Baseline anxiety at Day 42

  • Change in depression as measured by the Hamilton Depression Rating Scale (HAM-D)

    Change from Baseline depression at Day 42

  • Change in mood as measured by the Profile of Mood States (POMS)

    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)

    Change from Baseline memory at Day 42

  • Change in fluency as measure by Letter and Category Fluency test

    Change from Baseline fluency at Day 42

  • +4 more secondary outcomes

Study Arms (2)

Placebo

PLACEBO COMPARATOR
Dietary Supplement: Placebo

Proprietary Nutritional Supplement

EXPERIMENTAL
Dietary Supplement: Proprietary Nutritional Supplement

Interventions

Proprietary Nutritional SupplementDIETARY_SUPPLEMENT

2 capsules taken by mouth with morning and evening meals.

Proprietary Nutritional Supplement
PlaceboDIETARY_SUPPLEMENT

2 capsules taken by mouth with morning and evening meals.

Placebo

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Utah - Brain Institute

Salt Lake City, Utah, 84108, United States

Location

Related Publications (1)

  • 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.

    PMID: 32335159DERIVED

Study Officials

  • Deborah Yurgelun-Todd, Ph.D.

    University of Utah

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 30, 2015

First Posted

May 12, 2015

Study Start

April 1, 2015

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

August 3, 2016

Record last verified: 2016-08

Locations

US(1)