Dietary Intervention With Brain-friendly Diet

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.

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