An interventional study of Control diet and Intervention diet in Physiological Stress, Cognitive Performance and LDL Cholesterol, sponsored by Fazer Group. Completed at 1 site in Finland. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-06-20.
Sponsored by Fazer Group · Not applicable, Interventional, and Other
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.
985 studies on the registry are indexed under Feeding Behavior; 178 are open to participants now.
This study's enrollment of 88 is above the median of 77 across 700 interventional studies indexed under Feeding Behavior.
Browse Feeding Behavior studies →This is the only study on the registry with Fazer Group as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Regular diet
Other: Control diet
Brainfood diet
Other: Intervention diet
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.
Also known as: Brainfood diet
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
Number of adverse events
Number of adverse events
Time frame: 8 weeks
Plan to share: No
No publications or documents are linked to this record.
Ran from Aug 2017 to primary completion in Apr 2018, 7 months.
Of 515 interventional studies with no phase under Feeding Behavior, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 31. This study's 7 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.
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