Clinical trial NCT03346486: Dietary Intervention With Brain-friendly Diet
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physiological Stress
Cognitive Performance
LDL Cholesterol
Keywords: Diet
Metabolites
Cognitive function
Physiology
LDL
Diet Habit
Diet Modification
Lead sponsor: Fazer Group
Sponsor class: INDUSTRY
Collaborators: name: Nokia Technologies Oy
name: Nightingale Health Oy
name: Tekes - the Finnish Funding Agency for Innovation
name: Finnish Institute of Occupational Health (FIOH)
name: Oy Medfiles Ltd
First posted: 2017-11-17
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Open, fixed sequence diet-switch 4-week intervention
Primary purpose: OTHER

Brief summary: 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: 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.

Eligibility criteria: Inclusion criteria

1. Signed written informed consent
2. Age 18-65 years
3. 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.
4. Male or female with at least 1/3 of the gender defined predominant among screened participants with assumed metabolic risk
5. Adequate Finnish or English skill to comprehend trial related instructions and questionnaires
6. Chest circumference of 75 to 115 cm (limits included)

Exclusion criteria

1. High probability to travel for more than one working day a week during the trial
2. 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
3. Allergies restricting compliance with control or intervention diet (celiac disease, gluten free diet, stringent FODMAP diet)
4. Nickel allergy
5. 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
6. Diagnosed type 1 or type 2 diabetes requiring treatment
7. Inflammatory bowel disease or other intestinal or oesophageal disease requiring medical treatment or likely to have a nutritional affect
8. History of malignant diseases like cancer within five years prior to recruitment
9. Lipid lowering medication (statin, cholestyramine) or medication for obesity (orlistat, or liraglutide) or depression
10. Alcohol abuse (\> 4 portion/per day) or recreational drug abuse
11. Pregnancy or planned pregnancy or lactating
12. Suspected low compliance according to the investigator's assessment

Primary outcomes:
measure: Change in LDL cholesterol
timeFrame: 8 weeks
Secondary outcomes:
measure: Change in serum metabolite concentrations
timeFrame: 8 weeks
measure: Change in cognitive performance
timeFrame: 4 weeks
measure: Changes in self-reported vigilance
timeFrame: 4 weeks
measure: Changes in self-reported task load
timeFrame: 4 weeks
measure: Daily pulse profile (evening- night- morning)
timeFrame: 8 weeks
measure: Daily profile of heart rate variability (evening- night- morning)
timeFrame: 8 weeks
measure: Change in dietary habits and nutrient intake
timeFrame: 8 weeks
measure: Number of adverse events
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Espoo
country: Finland
facility: Medfiles BRAVE clinic
Study officials:
affiliation: FIOH
name: Arja Uusitalo, MD
role: PRINCIPAL_INVESTIGATOR
References: