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Genetic Information as a Life Style Change Motivator

Effects of ApoE4 Genotype Information and Intervention Intensity on the Fulfillment of Lifestyle Changes and Sensory Preferences

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03794141
Acronym
APOE4MOT
Enrollment
333
Registered
2019-01-04
Start date
2017-01-02
Completion date
2019-07-31
Last updated
2020-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer Disease, Protection Against, Health Behavior

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.

Interventions

BEHAVIORALinformation on the risk gene status

information on risk gene status (APOE4 allele or not) was given before intervention

BEHAVIORALlife style advise

all test persons were given information on healthy diet and life style

Sponsors

University of Turku
CollaboratorOTHER
University of Eastern Finland
CollaboratorOTHER
Academy of Finland
CollaboratorOTHER
Natural Resources Institute Finland
Lead SponsorOTHER_GOV

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
40 Years to 60 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
APOE and BDNF genotypebaseline
Number of participants with good quality of dietary fat2 yearsA questionnaire according to Finnish guidelines of Suomen Sydänliitto ry, Helldán & Helakorpi, (2015)
Dietary habits, number of participants2 yearsA questionnaire asking for * Fish intake at least twice per week * Consumption of high fat and sugar foods * Consumption of vegetables * Alcohol consumption * Physical activity at least twice per week
Food choice questionnaire, health and taste attitude2 yearsScale 1-7 (7 most important, fully agree)
Food involvement and Food mavenism, scale 1-52 years5 fully agree
Health concern, scale 1-92 years1 not concerned at all
Life-orientation test, scale 1-52 years1 fully agree
Locus of Control, state-trait anxiety inventory, Three-Factor Eating Questionnaire (TFEQ) scale 1-42 years4 fully agree
weight kg2 years
height m2 years
Waist circumference, cm2 years
Visceral fat level (1-30)2 years
blood pressure, mmHg2 years
Serum lipid levels mmol/L2 years
Blood glucose levels, mmol/L2 years
Serum lipid peroxidation, MDA/µM2 years
Serum Sensitive C reactive protein, mg/L2 years
Serum Hemoglobin, g/L2 years
Serum Alkaline phosphatase, U/L2 years
Serum Alanine aminotransferase, U/L2 years
Serum haptoglobin, g/L2 years
Plasma thyrotropin, mU/L2 years
serum APOE protein, mg/L2 years
serum brain-derived neurotrophic factor, ng/ml2 years
serum Fatty acids, g/100g fatty acids2 years
serum Carotenoids, retinol and α-tocopherol, Plasma total phenolics ng/µl2 years
Blood cell count2 years

Secondary

MeasureTime frameDescription
Body mass index2 yearsweight and height will be combined to report BMI in kg/m\^2

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026