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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
88
Regular diet
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.
Medfiles BRAVE clinic
Espoo, Finland
Change in LDL cholesterol
Change in serum LDL concentration between control period and intervention period
Time frame: 8 weeks
Change in serum metabolite concentrations
Change in serum metabolite concentrations
Time frame: 8 weeks
Change in cognitive performance
Change in cognitive performance
Time frame: 4 weeks
Changes in self-reported vigilance
Changes in self-reported vigilance
Time frame: 4 weeks
Changes in self-reported task load
Changes in self-reported task load
Time frame: 4 weeks
Daily pulse profile (evening- night- morning)
Changes in pulse profile (evening- night- morning), mean level, between control period and intervention period
Time frame: 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
Time frame: 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
Time frame: 8 weeks
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Number of adverse events
Number of adverse events
Time frame: 8 weeks