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| Name | Class |
|---|---|
| Nokia Technologies Oy | UNKNOWN |
| Nightingale Health Oy | UNKNOWN |
| The Finnish Funding Agency for Technology and Innovation | OTHER_GOV |
| Finnish Institute of Occupational Health |
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To evaluate the effect of dietary intervention on metabolic risk profile, and on potential simultaneous changes in physiological and cognitive functions and to collect a unique database using state-of-the-art technologies on variables related to the above mentioned areas.
The study is compiled from 4 phases: 1) a pilot study to evaluate performance and feasibility of the measurements and logistics for the BRAVE intervention study (N=10), 2) a pre-screening phase to select volunteers for the intervention study based on metabolite analyses (N=600), 3) the BRAVE intervention study as a controlled non-randomized open-label fixed sequence diet switch trial (N=88)and 4) a non-interventional reference group to estimate the learning effect due to repeated cognitive testing (N=30).
The Brainfood dietary regime is planned optimal for metabolism and cognitive function; having focus on regular meal frequency (breakfast, lunch and afternoon snack) and well-balanced light lunch at work -according to the so-called plate model and optimized recipes- will be provided.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control diet | Placebo Comparator | Regular diet |
|
| Intervention diet | Active Comparator | Brainfood diet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Control diet | Other | Regular diet |
| |
| Intervention diet |
| Measure | Description | Time Frame |
|---|---|---|
| Change in LDL cholesterol | Change in serum LDL concentration between control period and intervention period | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in serum metabolite concentrations | Change in serum metabolite concentrations | 8 weeks |
| Change in cognitive performance | Change in cognitive performance |
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Inclusion criteria
Exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Arja Uusitalo, MD | FIOH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medfiles BRAVE clinic | Espoo | Finland |
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| ID | Term |
|---|---|
| D005247 | Feeding Behavior |
| ID | Term |
|---|---|
| D001522 | Behavior, Animal |
| D001519 | Behavior |
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| OTHER |
| Oy Medfiles Ltd | INDUSTRY |
Open, fixed sequence diet-switch 4-week intervention
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| Other |
Brainfood dietary regime planned to be optimal for metabolism and cognitive function; having focus on regular meal frequency (breakfast, lunch and afternoon snack) and well-balanced light lunch at work according to the so-called plate model and optimized recipes- will be provided. |
|
|
| 4 weeks |
| Changes in self-reported vigilance | Changes in self-reported vigilance | 4 weeks |
| Changes in self-reported task load | Changes in self-reported task load | 4 weeks |
| Daily pulse profile (evening- night- morning) | Changes in pulse profile (evening- night- morning), mean level, between control period and intervention period | 8 weeks |
| Daily profile of heart rate variability (evening- night- morning) | Changes in heart rate variability profile (evening- night- morning), between control period and intervention period | 8 weeks |
| Change in dietary habits and nutrient intake | Change in dietary habits and nutrient intake according to a standard 3-day food record between control period and intervention period | 8 weeks |
| Number of adverse events | Number of adverse events | 8 weeks |