Clinical Trials Directory

Trials / Completed

CompletedNCT03346486

Dietary Intervention With Brain-friendly Diet

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
88 (actual)
Sponsor
Fazer Group · Industry
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERControl dietRegular diet
OTHERIntervention dietBrainfood 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.

Timeline

Start date
2017-08-24
Primary completion
2018-04-03
Completion
2018-04-03
First posted
2017-11-17
Last updated
2018-06-20

Locations

1 site across 1 country: Finland

Source: ClinicalTrials.gov record NCT03346486. Inclusion in this directory is not an endorsement.