APOE4MOT: Genetic Information as a Life Style Change Motivator

Sponsor
Natural Resources Institute Finland (Other)
Overall Status
Completed
CT.gov ID
NCT03794141
Collaborator
University of Turku (Other), University of Eastern Finland (Other), Academy of Finland (Other)
333
3
30.9

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: information on the risk gene status
  • Behavioral: life style advise
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
333 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Effects of ApoE4 Genotype Information and Intervention Intensity on the Fulfillment of Lifestyle Changes and Sensory Preferences
Actual Study Start Date :
Jan 2, 2017
Actual Primary Completion Date :
Mar 30, 2019
Actual Study Completion Date :
Jul 31, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Tervas

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

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

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

Experimental: Informed

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

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

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

Active Comparator: non informed

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

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

Outcome Measures

Primary Outcome Measures

  1. Number of participants with good quality of dietary fat [2 years]

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

  2. 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

  3. Food choice questionnaire, health and taste attitude [2 years]

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

  4. Food involvement and Food mavenism, scale 1-5 [2 years]

    5 fully agree

  5. Health concern, scale 1-9 [2 years]

    1 not concerned at all

  6. Life-orientation test, scale 1-5 [2 years]

    1 fully agree

  7. Locus of Control, state-trait anxiety inventory, Three-Factor Eating Questionnaire (TFEQ) scale 1-4 [2 years]

    4 fully agree

  8. weight kg [2 years]

  9. height m [2 years]

  10. Waist circumference, cm [2 years]

  11. Visceral fat level (1-30) [2 years]

  12. blood pressure, mmHg [2 years]

  13. Serum lipid levels mmol/L [2 years]

  14. Blood glucose levels, mmol/L [2 years]

  15. Serum lipid peroxidation, MDA/µM [2 years]

  16. Serum Sensitive C reactive protein, mg/L [2 years]

  17. Serum Hemoglobin, g/L [2 years]

  18. Serum Alkaline phosphatase, U/L [2 years]

  19. Serum Alanine aminotransferase, U/L [2 years]

  20. Serum haptoglobin, g/L [2 years]

  21. Plasma thyrotropin, mU/L [2 years]

  22. serum APOE protein, mg/L [2 years]

  23. serum brain-derived neurotrophic factor, ng/ml [2 years]

  24. serum Fatty acids, g/100g fatty acids [2 years]

  25. serum Carotenoids, retinol and α-tocopherol, Plasma total phenolics ng/µl [2 years]

  26. Blood cell count [2 years]

  27. APOE and BDNF genotype [baseline]

Secondary Outcome Measures

  1. Body mass index [2 years]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 60 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Natural Resources Institute Finland
  • University of Turku
  • University of Eastern Finland
  • Academy of Finland

Investigators

  • Study Director: Raija Tahvonen, Prof, Natural Resources Institute Finland

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Natural Resources Institute Finland
ClinicalTrials.gov Identifier:
NCT03794141
Other Study ID Numbers:
  • 41007-00040400
First Posted:
Jan 4, 2019
Last Update Posted:
Feb 26, 2020
Last Verified:
Dec 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 26, 2020