Dietary Intervention With Brain-friendly Diet (BRAVE)

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

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.

Study Overview

• Status: Completed
• Conditions: Cognitive Performance; Physiological Stress; LDL Cholesterol
• Intervention / Treatment: Other: Control diet; Other: Intervention diet

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.

• Study Type: Interventional
• Enrollment (Actual): 88
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Finland
  • Espoo, Finland
    • Medfiles BRAVE clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control diet; Regular diet	Other: Control diet; Regular diet
Active Comparator: Intervention diet; Brainfood diet	Other: Intervention 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.; Other Names: Brainfood diet

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Fazer Group
• Collaborators: Nokia Technologies Oy; Nightingale Health Oy; Tekes - the Finnish Funding Agency for Innovation; Finnish Institute of Occupational Health (FIOH); Oy Medfiles Ltd
• Investigators: Principal Investigator: Arja Uusitalo, MD, FIOH

Study record dates

Study Major Dates

• Study Start (Actual): August 24, 2017
• Primary Completion (Actual): April 3, 2018
• Study Completion (Actual): April 3, 2018

Study Registration Dates

• First Submitted: August 24, 2017
• First Submitted That Met QC Criteria: November 14, 2017
• First Posted (Actual): November 17, 2017

Study Record Updates

• Last Update Posted (Actual): June 20, 2018
• Last Update Submitted That Met QC Criteria: June 19, 2018
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: Diet; Cognitive function; Metabolites; Physiology; LDL; Diet Modification; Diet Habit
• Other Study ID Numbers: MFBF008 BRAVE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No