Dietary Intervention With Brain-friendly Diet

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Open, Fixed Sequence Diet-switch 4-week Intervention on the Effects of Brain-friendly Diet on Metabolic and Physiological Parameters and Cognitive Performance in Office Workers at Assumed Metabolic Risk

Conditions
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Physiological Stress, Cognitive Performance, LDL Cholesterol

Intervention / Treatment
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* Other: Control diet
* Other: Intervention diet


Participation Criteria
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Eligibility Criteria
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Inclusion criteria Signed written informed consent Age 18-65 years Assumed metabolic risk based on pre-screening assessment of glucose and lipid metabolism related metabolites defined initially as being within the most impaired quartile with reference to available metabolite data-base from a comparable population. If recruitment efficiency requires, having a metabolic profile within the most impaired half instead of a quartile may be applied. Male or female with at least 1/3 of the gender defined predominant among screened participants with assumed metabolic risk Adequate Finnish or English skill to comprehend trial related instructions and questionnaires Chest circumference of 75 to 115 cm (limits included) Exclusion criteria High probability to travel for more than one working day a week during the trial Expected or planned major changes in lifestyle (diet, level of exercise, significant changes in work) or involved in the R&D of the measuring devices applied in the trial Allergies restricting compliance with control or intervention diet (celiac disease, gluten free diet, stringent FODMAP diet) Nickel allergy History of unstable coronary artery disease (myocardial infarction, coronary artery bypass graft (CABG), percutaneous transluminal coronary angioplasty (PTCA), temporal ischemic attack within the previous 6 months Diagnosed type 1 or type 2 diabetes requiring treatment Inflammatory bowel disease or other intestinal or oesophageal disease requiring medical treatment or likely to have a nutritional affect History of malignant diseases like cancer within five years prior to recruitment Lipid lowering medication (statin, cholestyramine) or medication for obesity (orlistat, or liraglutide) or depression Alcohol abuse (> 4 portion/per day) or recreational drug abuse Pregnancy or planned pregnancy or lactating Suspected low compliance according to the investigator's assessment

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Open, fixed sequence diet-switch 4-week intervention
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control diet<br>Regular diet | Other: Control diet<br>* Regular diet<br>|
| Active Comparator: Intervention diet<br>Brainfood diet | Other: Intervention diet<br>* 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.<br>* Other names: Brainfood diet;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in LDL cholesterol | Change in serum LDL concentration between control period and intervention period | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in serum metabolite concentrations | Change in serum metabolite concentrations | 8 weeks | 
| Change in cognitive performance | Change in cognitive performance | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diet, Metabolites, Cognitive function, Physiology, LDL, Diet Habit, Diet Modification