Genetic Information as a Life Style Change Motivator

Not Applicable

Completed

• Conditions: Alzheimer Disease, Protection Against; Health Behavior

• Registration Number: NCT03794141
• Lead Sponsor: Natural Resources Institute Finland

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.

Study Timeline

• Study Start: 2017-01-02
• Status Verified: 2018-12
• Study First Submitted: 2018-12-13
• Study First Submitted QC: 2019-01-02
• Study First Posted: 2019-01-04
• Primary Completion: 2019-03-30
• Study Completion: 2019-07-31
• Last Update Submitted: 2020-02-25
• Last Update Posted: 2020-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 333

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Health concern, scale 1-9	2 years	1 not concerned at all
blood pressure, mmHg	2 years
Serum lipid peroxidation, MDA/µM	2 years
Serum Alkaline phosphatase, U/L	2 years
serum Fatty acids, g/100g fatty acids	2 years
serum APOE protein, mg/L	2 years
serum brain-derived neurotrophic factor, ng/ml	2 years
Waist circumference, cm	2 years
Serum haptoglobin, g/L	2 years
Food involvement and Food mavenism, scale 1-5	2 years	5 fully agree
Number of participants with good quality of dietary fat	2 years	A questionnaire according to Finnish guidelines of Suomen Sydänliitto ry, Helldán \& Helakorpi, (2015)
Dietary habits, number of participants	2 years	A 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 attitude	2 years	Scale 1-7 (7 most important, fully agree)
Life-orientation test, scale 1-5	2 years	1 fully agree
height m	2 years
Visceral fat level (1-30)	2 years
Serum Sensitive C reactive protein, mg/L	2 years
Locus of Control, state-trait anxiety inventory, Three-Factor Eating Questionnaire (TFEQ) scale 1-4	2 years	4 fully agree
Serum lipid levels mmol/L	2 years
Blood glucose levels, mmol/L	2 years
weight kg	2 years
Serum Hemoglobin, g/L	2 years
Plasma thyrotropin, mU/L	2 years
APOE and BDNF genotype	baseline
Serum Alanine aminotransferase, U/L	2 years
serum Carotenoids, retinol and α-tocopherol, Plasma total phenolics ng/µl	2 years
Blood cell count	2 years

Secondary Outcome Measures

Name	Time	Method
Body mass index	2 years	weight and height will be combined to report BMI in kg/m\^2