Physiological StressBRAVENCT03346486
Dietary Intervention With Brain-friendly Diet
A study testing Intervention diet in people with Physiological Stress and Cognitive Performance, run by Fazer Group at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Physiological Stress, Cognitive Performance, LDL Cholesterol
- What is being tested?
- Intervention diet
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 1 siteFinland
- Study dates
- 24 Aug 2017to 3 Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Physiological Stress, Cognitive Performance, LDL Cholesterol
- Being tested
- Control diet, Intervention diet
- Keywords
- Diet, Metabolites, Cognitive function, Physiology, LDL, Diet Habit, Diet Modification
- Medical subject headings
- Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control dietOther
Regular diet
Intervention dietOther
Also called Brainfood 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.
| Study group | Role | What they receive |
|---|---|---|
| Control diet | Placebo comparator | Regular diet Receives: Other: Control diet |
| Intervention diet | Active comparator | Brainfood diet Receives: Other: Intervention diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in LDL cholesterol
Change in serum LDL concentration between control period and intervention period
Measured: 8 weeks
Secondary outcomes (8)
Change in serum metabolite concentrations
Change in serum metabolite concentrations
Measured: 8 weeks
Change in cognitive performance
Change in cognitive performance
Measured: 4 weeks
Changes in self-reported vigilance
Changes in self-reported vigilance
Measured: 4 weeks
Changes in self-reported task load
Changes in self-reported task load
Measured: 4 weeks
Daily pulse profile (evening- night- morning)
Changes in pulse profile (evening- night- morning), mean level, between control period and intervention period
Measured: 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
Measured: 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
Measured: 8 weeks
Number of adverse events
Number of adverse events
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start24 Aug 2017
- Primary completion3 Apr 2018
- Study completion3 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physiological StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- Open, fixed sequence diet-switch 4-week intervention
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fazer Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Nokia Technologies Oy, Nightingale Health Oy, The Finnish Funding Agency for Technology and Innovation, Finnish Institute of Occupational Health, Oy Medfiles Ltd
- Responsible party
- Sponsor
- Investigators
- Arja Uusitalo, MD, Principal investigator, FIOH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03346486
- Sponsor's protocol ID
- MFBF008 BRAVE
- Acronym
- BRAVE
- Status last verified
- Sep 2017
- First submitted
- 24 Aug 2017
- Last updated
- 20 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03346486
- Acronym / sponsor ID
- BRAVE / MFBF008 BRAVE
- Conditions
- Physiological Stress, Cognitive Performance, LDL Cholesterol
- Keywords
- Diet, Metabolites, Cognitive function, Physiology, LDL, Diet Habit, Diet Modification
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Fazer GroupIndustry (pharma, biotech, devices)
- Collaborators
- Nokia Technologies Oy, Nightingale Health Oy, The Finnish Funding Agency for Technology and Innovation, Finnish Institute of Occupational Health, Oy Medfiles Ltd
- Study start
- 24 Aug 2017 (actual)
- Primary completion
- 3 Apr 2018 (actual)
- Study completion
- 3 Apr 2018 (actual)
- First posted
- 17 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open, fixed sequence diet-switch 4-week intervention
| Arm | Type | Receives |
|---|---|---|
| Control diet | Placebo comparator | Other: Control dietRegular diet |
| Intervention diet | Active comparator | Other: Intervention dietBrainfood diet |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Control dietRegular diet | Other | Control diet |
| Intervention dietAlso: Brainfood 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. | Other | Intervention diet |
Primary outcome
Change in LDL cholesterol
Time frame: 8 weeks
Change in serum LDL concentration between control period and intervention period
8 secondary outcomes
Change in serum metabolite concentrations
Time frame: 8 weeks
Change in cognitive performance
Time frame: 4 weeks
Changes in self-reported vigilance
Time frame: 4 weeks
Changes in self-reported task load
Time frame: 4 weeks
Daily pulse profile (evening- night- morning)
Time frame: 8 weeks
Daily profile of heart rate variability (evening- night- morning)
Time frame: 8 weeks
Change in dietary habits and nutrient intake
Time frame: 8 weeks
Number of adverse events
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arja Uusitalo, MD principal investigator
FIOH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention diet in people with Physiological Stress and Cognitive Performance, run by Fazer Group at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in LDL cholesterol (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2018.