Status:
COMPLETED
Dietary Intervention With Brain-friendly Diet
Lead Sponsor:
Fazer Group
Collaborating Sponsors:
Nokia Technologies Oy
Nightingale Health Oy
Conditions:
Physiological Stress
Cognitive Performance
Eligibility:
All Genders
18-65 years
Phase:
NA
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...
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 sel...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
August 24 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 3 2018
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT03346486
Start Date
August 24 2017
End Date
April 3 2018
Last Update
June 20 2018
Active Locations (1)
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1
Medfiles BRAVE clinic
Espoo, Finland