Dietary Intervention With Brain-friendly Diet

Not Applicable

Completed

• Conditions: Physiological Stress; LDL Cholesterol; Cognitive Performance
• Interventions: Other: Control diet; Other: Intervention diet

• Registration Number: NCT03346486
• Lead Sponsor: Fazer Group

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.

Study Timeline

• Study Start: 2017-08-24
• Study First Submitted: 2017-08-24
• Status Verified: 2017-09
• Study First Submitted QC: 2017-11-14
• Study First Posted: 2017-11-17
• Primary Completion: 2018-04-03
• Study Completion: 2018-04-03
• Last Update Submitted: 2018-06-19
• Last Update Posted: 2018-06-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Control diet	Control diet	Regular diet
Intervention diet	Intervention diet	Brainfood diet

Primary Outcome Measures

Name	Time	Method
Change in LDL cholesterol	8 weeks	Change in serum LDL concentration between control period and intervention period

Secondary Outcome Measures

Name	Time	Method
Changes in self-reported vigilance	4 weeks	Changes in self-reported vigilance
Change in serum metabolite concentrations	8 weeks	Change in serum metabolite concentrations
Change in cognitive performance	4 weeks	Change in cognitive performance
Changes in self-reported task load	4 weeks	Changes in self-reported task load
Daily pulse profile (evening- night- morning)	8 weeks	Changes in pulse profile (evening- night- morning), mean level, between control period and intervention period
Daily profile of heart rate variability (evening- night- morning)	8 weeks	Changes in heart rate variability profile (evening- night- morning), between control period and intervention period
Number of adverse events	8 weeks	Number of adverse events
Change in dietary habits and nutrient intake	8 weeks	Change in dietary habits and nutrient intake according to a standard 3-day food record between control period and intervention period

Trial Locations

Locations (1)

Medfiles BRAVE clinic; 🇫🇮 Espoo, Finland