Dietary Intervention With Brain-friendly Diet

Cognitive Performance Clinical Trial

— BRAVE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03346486
• Other study ID #: MFBF008 BRAVE
• Status: Completed
• Phase: N/A
• Start date: August 24, 2017
• Est. completion date: April 3, 2018

Study information

• Verified date: September 2017
• Source: Fazer Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: April 3, 2018
• Est. primary completion date: April 3, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Performance
• LDL Cholesterol
• Physiological Stress

Intervention

Other:
• Control diet
Regular diet
• 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.

Locations

Country	Name	City	State
Finland	Medfiles BRAVE clinic	Espoo

Sponsors (6)

Lead Sponsor	Collaborator
Fazer Group	Finnish Institute of Occupational Health (FIOH), Nightingale Health Oy, Nokia Technologies Oy, Oy Medfiles Ltd, Tekes - the Finnish Funding Agency for Innovation

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in LDL cholesterol	Change in serum LDL concentration between control period and intervention period	8 weeks
Secondary	Change in serum metabolite concentrations	Change in serum metabolite concentrations	8 weeks
Secondary	Change in cognitive performance	Change in cognitive performance	4 weeks
Secondary	Changes in self-reported vigilance	Changes in self-reported vigilance	4 weeks
Secondary	Changes in self-reported task load	Changes in self-reported task load	4 weeks
Secondary	Daily pulse profile (evening- night- morning)	Changes in pulse profile (evening- night- morning), mean level, between control period and intervention period	8 weeks
Secondary	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
Secondary	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
Secondary	Number of adverse events	Number of adverse events	8 weeks