Sub-optimal Cognitive FunctionNCT01672359
Evaluating Whole Foods Supplementation on Cognition
A study testing Ginkgo Synergy® and Choline and OPC Synergy® and Catalyn in people with Sub-optimal Cognitive Function and Sub-optimal Immune Function, run by University of Miami at 1 site in United States.
Trial summary
A six-month study which investigated the effect of Ginkgo Synergy® and Choline or OPC Synergy® and Catalyn® on cognitive and immune function markers and quality of life among healthy older adults with no history of significant cognitive deficits Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sub-optimal Cognitive Function, Sub-optimal Immune Function
- What is being tested?
- Ginkgo Synergy® and Choline and OPC Synergy® and Catalyn
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 97 participants
- Where
- 1 siteUnited States
- Study dates
- May 2011to Dec 2011
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 60 years of age and older
- English speaking
- Not living in a skilled or intermediate care level nursing facility
- No use of dietary supplements for cognitive functioning two weeks before enrolling in the study and during the length of the trial
- A Mini-Mental State Exam (MMSE) score ≥ 23
Who cannot join
- A cognitive deficit greater than that indicated according to the MMSE score
- A clinical diagnosis of AD and/or related disorders
- A psychiatric diagnosis of schizophrenia, other psychotic disorders, bipolar disorder, major depression with psychotic features, delirium, and alcohol or substance abuse/dependence
- Bleeding disorders
- Aphasia or sensory, motor, and/or visual disturbances that would have interfered with psychometric tests
- Gastrointestinal disorders causing impaired absorption of the study supplements
Show all 20Show fewer
- Insulin-dependent diabetes
- Major conditions such as cardiovascular, pulmonary, renal, thyroid, hepatic, gastrointestinal, or seizure
- Hematologic or oncologic disorders treated with chemotherapy in the previous two years
- Active chemotherapy or radiation treatment for cancer
- Current cigarette smoking
- More than three major medical or psychiatric hospitalizations in the past year
- Diagnosis of a terminal illness
- A T score > 70 on the Global Severity Index of the Brief Symptoms Inventory (BSI)
- A score ≥ 29 on the Beck Depression Inventory-II (BDI) (15)
- Prescription and OTC sympathomimetic amines and antihistamines within 2 days of an assessment visit
- Cognition enhancing drugs consumption such as Donepezil, Rivastigmine, Galantamine, and Tacrine
- Coumadin, tricyclic antidepressants, antipsychotics, and anticonvulsants
- Cognition-enhancing supplements, herbs, or antioxidants that could not be stopped during the trial
- Participating in a concurrent trial for drugs, supplements, or treatment that affects behavior or cognitive function
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Whole-Food Dietary Supplementation on Cognitive and Immune Functioning and Quality of Life in Healthy Older Adults
A six-month study which investigated the effect of Ginkgo Synergy® and Choline or OPC Synergy® and Catalyn® on cognitive and immune function markers and quality of life among healthy older adults with no history of significant cognitive deficits
- Being tested
- Ginkgo Synergy® and Choline, OPC Synergy® and Catalyn, Placebo
- Keywords
- cognitive functioning, immune function, cytokines, growth factors, quality of life, dietary supplementation, Ginkgo biloba, Improvement of cognitive function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ginkgo Synergy® and CholineDietary supplement
3 tablets 2 times per day with breakfast and dinner over 6 months
OPC Synergy® and CatalynDietary supplement
3 tablets 2 times per day with breakfast and dinner over 6 months
PlaceboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Ginkgo Synergy® and Choline | Experimental | Ginkgo Synergy® (120 mg/day Ginkgo biloba leaf with 80 mg/day Ginkgo biloba whole extract combined with 40 mg/day Grape Seed extract) and Choline (700 mg choline/day) Receives: Dietary Supplement: Ginkgo Synergy® and Choline |
| OPC Synergy® and Catalyn | Experimental | OPC Synergy® (100 mg/day of Grape Seed extract with 50 mg/day Green Tea extract (60% catechins)) and Catalyn® (1,248 IU/day of Vitamin D, 4,800 IU/day of Vitamin A, combined with vitamin C, thiamine, riboflavin, and vitamin B6) Receives: Dietary Supplement: OPC Synergy® and Catalyn |
| Placebo | Placebo comparator | cellulose pills to simulate actual products Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive Measures
The measures included the MMSE, the Stroop Color and Word Test (SCWT), the Trail Making Test Parts A and B (TMT-A, TMT-B), the Controlled Oral Word Association test (COWA), the Digit Symbol subtest of the Wechsler Adult Intelligence Scale, Third Edition (WAIS-III), and the Hopkins Verbal Learning Test-Revised (HVLT-R)
Measured: 6 months
Secondary outcomes (2)
Quality of Life Measures
Quality of Well-Being Scale (QWBS) Medical Outcomes Study Short Form 36 (SF 36) Beck Depression Inventory (BDI) Beck Anxiety Inventory (BAI)
Measured: 6 months
Immune Function Markers
interleukin [IL]-2, IL-4, IL-6, IL-8, IL-10, IL-1α, IL-1β, interferon [IFN]-γ, tumor necrosis factor [TNF]-α, monocyte chemotactic protein [MCP]-1, vascular endothelial growth factor [VEGF], and epidermal growth factor [EGF]
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2012 (estimated)
- Study startMay 2011
- Primary completionDec 2011
- Study completionDec 2011
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 Sub-optimal Cognitive FunctionStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- Standard Process Inc.
- Responsible party
- Principal investigator, John E. Lewis, University of Miami
- Investigators
- John Lewis, PhD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01672359
- Sponsor's protocol ID
- 20090985
- Status last verified
- Aug 2014
- First submitted
- 20 Aug 2012
- Last updated
- 6 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Lewis JE, Melillo AB, Tiozzo E, Chen L, Leonard S, Howell M, Diaz J, Gonzalez K, Woolger JM, Konefal J, Paterson E, Barnes D. A double-blind, randomized clinical trial of dietary supplementation on cognitive and immune functioning in healthy older adults. BMC Complement Altern Med. 2014 Feb 4;14:43. doi: 10.1186/1472-6882-14-43.
PubMed 24495355
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Whole-Food Dietary Supplementation on Cognitive and Immune Functioning and Quality of Life in Healthy Older Adults
- ClinicalTrials.gov ID
- NCT01672359
- Acronym / sponsor ID
- 20090985
- Keywords
- cognitive functioning, immune function, cytokines, growth factors, quality of life, dietary supplementation, Ginkgo biloba, Improvement of cognitive function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- Standard Process Inc.
- Study start
- May 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 24 Aug 2012 (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.
A six-month study which investigated the effect of Ginkgo Synergy® and Choline or OPC Synergy® and Catalyn® on cognitive and immune function markers and quality of life among healthy older adults with no history of significant cognitive deficits
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ginkgo Synergy® and Choline | Experimental | Dietary Supplement: Ginkgo Synergy® and CholineGinkgo Synergy® (120 mg/day Ginkgo biloba leaf with 80 mg/day Ginkgo biloba whole extract combined with 40 mg/day Grape Seed extract) and Choline (700 mg choline/day) |
| OPC Synergy® and Catalyn | Experimental | Dietary Supplement: OPC Synergy® and CatalynOPC Synergy® (100 mg/day of Grape Seed extract with 50 mg/day Green Tea extract (60% catechins)) and Catalyn® (1,248 IU/day of Vitamin D, 4,800 IU/day of Vitamin A, combined with vitamin C, thiamine, riboflavin, and vitamin B6) |
| Placebo | Placebo comparator | Dietary Supplement: Placebocellulose pills to simulate actual products |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 60 years of age and older
- English speaking
- Not living in a skilled or intermediate care level nursing facility
- No use of dietary supplements for cognitive functioning two weeks before enrolling in the study and during the length of the trial
- A Mini-Mental State Exam (MMSE) score ≥ 23
Key exclusion criteria (20 listed)
- A cognitive deficit greater than that indicated according to the MMSE score
- A clinical diagnosis of AD and/or related disorders
- A psychiatric diagnosis of schizophrenia, other psychotic disorders, bipolar disorder, major depression with psychotic features, delirium, and alcohol or substance abuse/dependence
- Bleeding disorders
- Aphasia or sensory, motor, and/or visual disturbances that would have interfered with psychometric tests
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 |
|---|---|---|
| Ginkgo Synergy® and Choline3 tablets 2 times per day with breakfast and dinner over 6 months | Dietary supplement | Ginkgo Synergy® and Choline |
| OPC Synergy® and Catalyn3 tablets 2 times per day with breakfast and dinner over 6 months | Dietary supplement | OPC Synergy® and Catalyn |
| Placebo | Dietary supplement | Placebo |
Primary outcome
Cognitive Measures
Time frame: 6 months
The measures included the MMSE, the Stroop Color and Word Test (SCWT), the Trail Making Test Parts A and B (TMT-A, TMT-B), the Controlled Oral Word Association test (COWA), the Digit Symbol subtest of the Wechsler Adult Intelligence Scale, Third Edition (WAIS-III), and the Hopkins Verbal Learning Test-Revised (HVLT-R)
2 secondary outcomes
Quality of Life Measures
Time frame: 6 months
Immune Function Markers
Time frame: 6 months
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 6 Aug 2014.
- Derived from this study: PubMed 24495355Lewis JE, Melillo AB, Tiozzo E, Chen L, Leonard S, Howell M, Diaz J, Gonzalez K, Woolger JM, Konefal J, Paterson E, Barnes D. A double-blind, randomized clinical trial of dietary supplementation on cognitive and immune functioning in healthy older adults. BMC Complement Altern Med. 2014 Feb 4;14:43. doi: 10.1186/1472-6882-14-43.
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.
John Lewis, PhD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ginkgo Synergy® and Choline and OPC Synergy® and Catalyn in people with Sub-optimal Cognitive Function and Sub-optimal Immune Function, run by University of Miami 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 20 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 6 Aug 2014. 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?
Cognitive Measures (time frame: 6 months). 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 NCT01672359, 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 6 Aug 2014.