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Completed

NCT Number: NCT03794141

Genetic Information as a Life Style Change Motivator

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.

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Key information

Conditions

Health Behavior Alzheimer Disease Alzheimer Disease, Protection Against Behavior Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

40 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

information on the risk gene status

Behavioral

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

life style advise

Behavioral

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

Primary outcomes

  1. Number of participants with good quality of dietary fat

    Time frame: 2 years

    A questionnaire according to Finnish guidelines of Suomen Sydänliitto ry, Helldán & Helakorpi, (2015)

  2. Dietary habits, number of participants

    Time frame: 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

  3. Food choice questionnaire, health and taste attitude

    Time frame: 2 years

    Scale 1-7 (7 most important, fully agree)

  4. Food involvement and Food mavenism, scale 1-5

    Time frame: 2 years

    5 fully agree

  5. Health concern, scale 1-9

    Time frame: 2 years

    1 not concerned at all

  6. Life-orientation test, scale 1-5

    Time frame: 2 years

    1 fully agree

  7. Locus of Control, state-trait anxiety inventory, Three-Factor Eating Questionnaire (TFEQ) scale 1-4

    Time frame: 2 years

    4 fully agree

  8. weight kg

    Time frame: 2 years

  9. height m

    Time frame: 2 years

  10. Waist circumference, cm

    Time frame: 2 years

  11. Visceral fat level (1-30)

    Time frame: 2 years

  12. blood pressure, mmHg

    Time frame: 2 years

  13. Serum lipid levels mmol/L

    Time frame: 2 years

  14. Blood glucose levels, mmol/L

    Time frame: 2 years

  15. Serum lipid peroxidation, MDA/µM

    Time frame: 2 years

  16. Serum Sensitive C reactive protein, mg/L

    Time frame: 2 years

  17. Serum Hemoglobin, g/L

    Time frame: 2 years

  18. Serum Alkaline phosphatase, U/L

    Time frame: 2 years

  19. Serum Alanine aminotransferase, U/L

    Time frame: 2 years

  20. Serum haptoglobin, g/L

    Time frame: 2 years

  21. Plasma thyrotropin, mU/L

    Time frame: 2 years

  22. serum APOE protein, mg/L

    Time frame: 2 years

  23. serum brain-derived neurotrophic factor, ng/ml

    Time frame: 2 years

  24. serum Fatty acids, g/100g fatty acids

    Time frame: 2 years

  25. serum Carotenoids, retinol and α-tocopherol, Plasma total phenolics ng/µl

    Time frame: 2 years

  26. Blood cell count

    Time frame: 2 years

  27. APOE and BDNF genotype

    Time frame: baseline

Secondary outcomes

  1. Body mass index

    Time frame: 2 years

    weight and height will be combined to report BMI in kg/m^2

Sponsors and collaborators

Lead sponsor

Natural Resources Institute Finland

Other Gov

Collaborators

  • Academy of Finland
  • University of Eastern Finland
  • University of Turku

Registry information

Official study title

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

Acronym: APOE4MOT

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jan 4, 2019
Registry last updated
Feb 26, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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