The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12617000748314
Ethics application status
Approved
Date submitted
28/04/2017
Date registered
22/05/2017
Date last updated
22/05/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Dark chocolate flavanols and cognition, FlaSeCo-study
Scientific title
Dark chocolate flavanols and their effect on cognition in older people. FlaSeCo-study, RCT
Secondary ID [1] 291456 0
None
Universal Trial Number (UTN)
Trial acronym
FlaSeCo-Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prevention of impairment in cognition of older adults 302495 0
Condition category
Condition code
Diet and Nutrition 302054 302054 0 0
Other diet and nutrition disorders
Mental Health 302674 302674 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
FlaSeCo-trial. Participants eat dark chocolate 50 g per day eight weeks time period. Chocolate in intervention group consists flavanols 400 mg per 50 grams and in control group less than 100 mg flavanols per 50 g. Participants keep diary by ticking with "x" after they had eaten their daily chocolate. Possible uneaten chocolate will be brought back at the end of intervention.
Intervention code [1] 297508 0
Prevention
Intervention code [2] 297559 0
Treatment: Other
Comparator / control treatment
Participants in control group eat eight weeks dark chocolate 50 g per day. Chocolate consists less than 100 mg flavanols per 50 g .
Control group
Dose comparison

Outcomes
Primary outcome [1] 301528 0
Verbal flow, assessment of cognition
Timepoint [1] 301528 0
Baseline and eight weeks after randomisation
Primary outcome [2] 301529 0
Trail making test (TMT), assessment of cognition
Timepoint [2] 301529 0
Baseline and eight weeks after randomisation
Secondary outcome [1] 332930 0
Food and nutrient intake, 3-day food diary
Timepoint [1] 332930 0
Baseline and eight weeks after randomisation
Secondary outcome [2] 332932 0
Parts of CERAD, assessment of cognition
Timepoint [2] 332932 0
Baseline and eight weeks after randomisation
Secondary outcome [3] 332933 0
15D, assessment of quality of life
Timepoint [3] 332933 0
Baseline and after eight weeks
Secondary outcome [4] 332934 0
Blood lipids (total cholesterol, LDL, HDL, triglycerides) from blood samples
Timepoint [4] 332934 0
Baseline and after eight weeks
Secondary outcome [5] 332935 0
Blood glucose (fasting)
Timepoint [5] 332935 0
Baseline and after eight weeks
Secondary outcome [6] 332937 0
GDS-30, depression scale
Timepoint [6] 332937 0
Baseline and after eight weeks

Eligibility
Key inclusion criteria
65 -75 years of age and informed consent
Minimum age
65 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
BMI>32, smoking, use of statins. medication for hypertension

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other design features
Phase
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 8759 0
Finland
State/province [1] 8759 0

Funding & Sponsors
Funding source category [1] 295928 0
Commercial sector/Industry
Name [1] 295928 0
Fazer
Address [1] 295928 0
Fazerintie 6
01230 Vantaa
Country [1] 295928 0
Finland
Primary sponsor type
Charities/Societies/Foundations
Name
Society for Gerontological Nutrition in Finland
Address
Malmin kauppatie 26, 00700 Helsinki
Country
Finland
Secondary sponsor category [1] 294802 0
None
Name [1] 294802 0
Address [1] 294802 0
Country [1] 294802 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297205 0
Ethics Committee of Medicine
Ethics committee address [1] 297205 0
Biomedicum Helsinki 2 C, Tukholmankatu 8 C, PL 705, 00029 HUS
Ethics committee country [1] 297205 0
Finland
Date submitted for ethics approval [1] 297205 0
Approval date [1] 297205 0
03/04/2017
Ethics approval number [1] 297205 0

Summary
Brief summary
The aim of the study is to explore the effect of cacao flavanols on cognition among older people (65-75 years) who have not been diagnosed any severe medical condition and has normal cognition. In addition, the changes in participants’ blood glucose and lipids will be analysed.

The study is double blinded randomized controlled trial. Participants in the intervention group receive daily 50 grams dark chocolate that rich in flavanols, especially epicathecin. Control group receives 50 grams dark chocolate that is low in flavanols. Intervention lasts 8 weeks.

Participants will be recruited in the metropolitan area of Finland. Inclusion criteria is 65-75 years of age and no severe health problems. According to power calculation total number of participants is 100.

The main outcome measures are Verbal Flow (VF) and Trail Making Test (TMT). Food intake will be collected with food records for three days. Intakes of energy, nutrients and polyphenols will be assessed. Blood samples will be collected from the participants and changes in blood glucose and lipids will be measured.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 73334 0
A/Prof Merja Suominen
Address 73334 0
Society for Gerontological Nutrition in Finland, Malmin kauppatie 26, 00700 Helsinki
Country 73334 0
Finland
Phone 73334 0
+358505841995
Fax 73334 0
Email 73334 0
merja.suominen@gery.fi
Contact person for public queries
Name 73335 0
A/Prof Merja Suominen
Address 73335 0
Society for Gerontological Nutrition in Finland, Malmin kauppatie 26, 00700 Helsinki
Country 73335 0
Finland
Phone 73335 0
+358505841995
Fax 73335 0
Email 73335 0
merja.suominen@gery.fi
Contact person for scientific queries
Name 73336 0
A/Prof Merja Suominen
Address 73336 0
Society for Gerontological Nutrition in Finland, Malmin kauppatie 26, 00700 Helsinki
Country 73336 0
Finland
Phone 73336 0
+358505841995
Fax 73336 0
Email 73336 0
merja.suominen@gery.fi

No data has been provided for results reporting
Summary results
Not applicable