Lifestyle Intervention Program for Cognitive Impairment
NCT ID: NCT02741804
Last Updated: 2016-06-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
150 participants
INTERVENTIONAL
2016-05-31
2019-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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BBH-1001 Brain Health Supplement
Patients will be given supplement containing ingredients all approved by the FDA: Turmeric (125mg), fisetin (16.65mg), green tea leaf extract (17.5mg), EPA (75mg), DHA (150mg) and Vitamin D3 (250IU). Patients will take 4 softgels once per day for entire study duration (18 months).
BBH-1001 Brain Health Supplement
Treatment with supplement consisting of turmeric, fish oil, vitamin D and green tea extract OR placebo.
Lifestyle Intervention
All patients will be given lessons on 6 areas of lifestyle: nutrition, physical activity, meditation, sleep hygiene, cognitive activity, and social activity.
Brain Health Placebo
Patients will be given a pill resembling the study supplement, but instead consisting of Soybean oil (608mg). Patients will take 4 softgels once per day for the entire study duration (18 months).
Lifestyle Intervention
All patients will be given lessons on 6 areas of lifestyle: nutrition, physical activity, meditation, sleep hygiene, cognitive activity, and social activity.
Brain Health Placebo
Treatment with placebo consisting of soybean oil
Interventions
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BBH-1001 Brain Health Supplement
Treatment with supplement consisting of turmeric, fish oil, vitamin D and green tea extract OR placebo.
Lifestyle Intervention
All patients will be given lessons on 6 areas of lifestyle: nutrition, physical activity, meditation, sleep hygiene, cognitive activity, and social activity.
Brain Health Placebo
Treatment with placebo consisting of soybean oil
Eligibility Criteria
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Inclusion Criteria
* Experiencing memory, or cognitive problems
Exclusion Criteria
* Previously diagnosed dementia; suspected dementia after clinical assessment by study physician at screening visit
* Mini Mental State Examination (MMSE) score less than 20 points
* Disorders affecting safe engagement in the intervention (e.g., malignant disease, major depression, psychiatric disease, symptomatic cardiovascular disease, revascularization within 1 year previously)
* Unable to safely change diet
* Patients without the means to visit the clinic on the assigned dates
* Patients that cannot comply with the data gathering needs of the study
* Severe loss of vision, hearing, or communicative ability
* Disorders preventing cooperation as judged by the study physician
* Coincident participation in another intervention trial
* Allergy to any ingredient in the supplement or placebo (i.e. soybean oil)
* Patients with gallstones due to possible interactions with turmeric
* Participants who are unable to provide clearance from their physician to participate in the physical activity training, as well as confirmed by Dr. Sherzai during the neurological exam.
55 Years
ALL
No
Sponsors
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Cedars-Sinai Medical Center
OTHER
Responsible Party
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Ayesha Sherzai, MD
Staff Physician
Principal Investigators
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Ayesha Sherzai, MD
Role: PRINCIPAL_INVESTIGATOR
Cedars-Sinai Medical Center
Locations
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Cedars-Sinai Medical Center
Los Angeles, California, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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41387
Identifier Type: -
Identifier Source: org_study_id
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