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Genetic Information as a Life Style Change Motivator (APOE4MOT)

Primary Purpose

Health Behavior, Alzheimer Disease, Protection Against

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
information on the risk gene status
life style advise
Sponsored by
Natural Resources Institute Finland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Health Behavior

Eligibility Criteria

40 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Active Comparator

    Arm Label

    Tervas

    Informed

    non informed

    Arm Description

    Follow up group from an earlier study. Information on risk gene status. All test persons were given information on healthy diet and life style.

    Information on risk gene status was given before intervention. All test persons were given information on healthy diet and life style.

    Information on risk gene status was not given before intervention. All test persons were given information on healthy diet and life style.

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

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

    Full Information

    First Posted
    December 13, 2018
    Last Updated
    February 25, 2020
    Sponsor
    Natural Resources Institute Finland
    Collaborators
    University of Turku, University of Eastern Finland, Academy of Finland
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03794141
    Brief Title
    Genetic Information as a Life Style Change Motivator
    Acronym
    APOE4MOT
    Official Title
    Effects of ApoE4 Genotype Information and Intervention Intensity on the Fulfillment of Lifestyle Changes and Sensory Preferences
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2, 2017 (Actual)
    Primary Completion Date
    March 30, 2019 (Actual)
    Study Completion Date
    July 31, 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Natural Resources Institute Finland
    Collaborators
    University of Turku, University of Eastern Finland, Academy of Finland

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Health Behavior, Alzheimer Disease, Protection Against

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    333 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Tervas
    Arm Type
    Experimental
    Arm Description
    Follow up group from an earlier study. Information on risk gene status. All test persons were given information on healthy diet and life style.
    Arm Title
    Informed
    Arm Type
    Experimental
    Arm Description
    Information on risk gene status was given before intervention. All test persons were given information on healthy diet and life style.
    Arm Title
    non informed
    Arm Type
    Active Comparator
    Arm Description
    Information on risk gene status was not given before intervention. All test persons were given information on healthy diet and life style.
    Intervention Type
    Behavioral
    Intervention Name(s)
    information on the risk gene status
    Intervention Description
    information on risk gene status (APOE4 allele or not) was given before intervention
    Intervention Type
    Behavioral
    Intervention Name(s)
    life style advise
    Intervention Description
    all test persons were given information on healthy diet and life style
    Primary Outcome Measure Information:
    Title
    Number of participants with good quality of dietary fat
    Description
    A questionnaire according to Finnish guidelines of Suomen Sydänliitto ry, Helldán & Helakorpi, (2015)
    Time Frame
    2 years
    Title
    Dietary habits, number of participants
    Description
    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
    Time Frame
    2 years
    Title
    Food choice questionnaire, health and taste attitude
    Description
    Scale 1-7 (7 most important, fully agree)
    Time Frame
    2 years
    Title
    Food involvement and Food mavenism, scale 1-5
    Description
    5 fully agree
    Time Frame
    2 years
    Title
    Health concern, scale 1-9
    Description
    1 not concerned at all
    Time Frame
    2 years
    Title
    Life-orientation test, scale 1-5
    Description
    1 fully agree
    Time Frame
    2 years
    Title
    Locus of Control, state-trait anxiety inventory, Three-Factor Eating Questionnaire (TFEQ) scale 1-4
    Description
    4 fully agree
    Time Frame
    2 years
    Title
    weight kg
    Time Frame
    2 years
    Title
    height m
    Time Frame
    2 years
    Title
    Waist circumference, cm
    Time Frame
    2 years
    Title
    Visceral fat level (1-30)
    Time Frame
    2 years
    Title
    blood pressure, mmHg
    Time Frame
    2 years
    Title
    Serum lipid levels mmol/L
    Time Frame
    2 years
    Title
    Blood glucose levels, mmol/L
    Time Frame
    2 years
    Title
    Serum lipid peroxidation, MDA/µM
    Time Frame
    2 years
    Title
    Serum Sensitive C reactive protein, mg/L
    Time Frame
    2 years
    Title
    Serum Hemoglobin, g/L
    Time Frame
    2 years
    Title
    Serum Alkaline phosphatase, U/L
    Time Frame
    2 years
    Title
    Serum Alanine aminotransferase, U/L
    Time Frame
    2 years
    Title
    Serum haptoglobin, g/L
    Time Frame
    2 years
    Title
    Plasma thyrotropin, mU/L
    Time Frame
    2 years
    Title
    serum APOE protein, mg/L
    Time Frame
    2 years
    Title
    serum brain-derived neurotrophic factor, ng/ml
    Time Frame
    2 years
    Title
    serum Fatty acids, g/100g fatty acids
    Time Frame
    2 years
    Title
    serum Carotenoids, retinol and α-tocopherol, Plasma total phenolics ng/µl
    Time Frame
    2 years
    Title
    Blood cell count
    Time Frame
    2 years
    Title
    APOE and BDNF genotype
    Time Frame
    baseline
    Secondary Outcome Measure Information:
    Title
    Body mass index
    Description
    weight and height will be combined to report BMI in kg/m^2
    Time Frame
    2 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Raija Tahvonen, Prof
    Organizational Affiliation
    Natural Resources Institute Finland
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    33188400
    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.
    Results Reference
    derived

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