Clinical trial NCT03794141: Genetic Information as a Life Style Change Motivator
Official title: Effects of ApoE4 Genotype Information and Intervention Intensity on the Fulfillment of Lifestyle Changes and Sensory Preferences
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Behavior
Alzheimer Disease, Protection Against
Lead sponsor: Natural Resources Institute Finland
Sponsor class: OTHER_GOV
Collaborators: name: University of Turku
name: University of Eastern Finland
name: Academy of Finland
First posted: 2019-01-04
Enrollment: 333
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The study investigates whether information on having a risk genotype (ApoE4) and life style advisory information affects lifestyle changes and sensory preferences. The project studies also the ethic aspects of giving the information of risk genotype.

Detailed description: We will run intervention based on our earlier pilot study. It includes intensive intervention and a modification of our earlier pilot intervention. Our intervention methods are general lectures of the effects of healthy diet (Finnish Nutrition Recommendations 2014) and healthy lifestyle for all participants. Effects on motivation, attitudes and preferences will be studied and verified by questionnaires and risk factors of cardiovascular disease and Alzheimer disease by analyzing clinical markers of lipid metabolism, general phenotype markers and profiles of nutritional markers. Nutritional biomarkers will verify also the self-reported changes of diet in the questionnaires and in digital food diaries.

Eligibility criteria: Inclusion Criteria:

* Age between 40 and 60 years
* overall good health (no chronic conditions e.g. mental disorders, cancer, liver or kidney disease, current or previous diagnosis),
* body mass index (BMI) under 35 kg/m2,
* blood pressure under 140/90 mmHg (medication allowed),
* serum total cholesterol under 7.25 mmol/l (medication allowed)
* fasting plasma glucose level under 7 mmol/l.

Exclusion Criteria:

* Abnormal values of the alanine amino transferase, alkaline phosphatase, haptoglobin and thyroid stimulating hormone

Primary outcomes:
measure: Number of participants with good quality of dietary fat
timeFrame: 2 years
measure: Dietary habits, number of participants
timeFrame: 2 years
measure: Food choice questionnaire, health and taste attitude
timeFrame: 2 years
measure: Food involvement and Food mavenism, scale 1-5
timeFrame: 2 years
measure: Health concern, scale 1-9
timeFrame: 2 years
measure: Life-orientation test, scale 1-5
timeFrame: 2 years
measure: Locus of Control, state-trait anxiety inventory, Three-Factor Eating Questionnaire (TFEQ) scale 1-4
timeFrame: 2 years
measure: weight kg
timeFrame: 2 years
measure: height m
timeFrame: 2 years
measure: Waist circumference, cm
timeFrame: 2 years
measure: Visceral fat level (1-30)
timeFrame: 2 years
measure: blood pressure, mmHg
timeFrame: 2 years
measure: Serum lipid levels mmol/L
timeFrame: 2 years
measure: Blood glucose levels, mmol/L
timeFrame: 2 years
measure: Serum lipid peroxidation, MDA/µM
timeFrame: 2 years
measure: Serum Sensitive C reactive protein, mg/L
timeFrame: 2 years
measure: Serum Hemoglobin, g/L
timeFrame: 2 years
measure: Serum Alkaline phosphatase, U/L
timeFrame: 2 years
measure: Serum Alanine aminotransferase, U/L
timeFrame: 2 years
measure: Serum haptoglobin, g/L
timeFrame: 2 years
measure: Plasma thyrotropin, mU/L
timeFrame: 2 years
measure: serum APOE protein, mg/L
timeFrame: 2 years
measure: serum brain-derived neurotrophic factor, ng/ml
timeFrame: 2 years
measure: serum Fatty acids, g/100g fatty acids
timeFrame: 2 years
measure: serum Carotenoids, retinol and α-tocopherol, Plasma total phenolics ng/µl
timeFrame: 2 years
measure: Blood cell count
timeFrame: 2 years
measure: APOE and BDNF genotype
timeFrame: baseline
Secondary outcomes:
measure: Body mass index
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
affiliation: Natural Resources Institute Finland
name: Raija Tahvonen, Prof
role: STUDY_DIRECTOR
References:
citation: Leskinen HM, Tringham M, Karjalainen H, Iso-Touru TK, Hietaranta-Luoma HL, Marnila PJ, Pihlava JM, Hurme T, Kankaanpaa SJ, Puolijoki H, Akerman K, Tanner L, Sandell M, Vahakangas K, Hopia A, Tahvonen R, Rokka LS. APOE Genotype Disclosure and Lifestyle Advice in a Randomized Intervention Study with Finnish Participants. J Nutr. 2021 Jan 4;151(1):85-97. doi: 10.1093/jn/nxaa316.