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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Physiological Stress
- Sponsor
- Fazer Group
- Enrollment
- 88
- Locations
- 1
- Primary Endpoint
- Change in LDL cholesterol
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Change in LDL cholesterol
Time Frame: 8 weeks
Change in serum LDL concentration between control period and intervention period
Secondary Outcomes
- Change in serum metabolite concentrations(8 weeks)
- Change in cognitive performance(4 weeks)
- Changes in self-reported vigilance(4 weeks)
- Changes in self-reported task load(4 weeks)
- Daily pulse profile (evening- night- morning)(8 weeks)
- Daily profile of heart rate variability (evening- night- morning)(8 weeks)
- Number of adverse events(8 weeks)
- Change in dietary habits and nutrient intake(8 weeks)