AzTrials
AzTrials

Health BehaviorAPOE4MOTNCT03794141

Genetic Information as a Life Style Change Motivator

A study testing information on the risk gene status and life style advise in people with Health Behavior and Alzheimer Disease, Protection Against, run by Natural Resources Institute Finland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 to 60 yearsHealthy volunteers can take part
What is being tested?
information on the risk gene status and life style advise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
333 participants
Where
No sites listed yet
Study dates
2 Jan 2017to 31 Jul 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • Abnormal values of the alanine amino transferase, alkaline phosphatase, haptoglobin and thyroid stimulating hormone

About this study

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

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.

Read the 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.

Being tested
information on the risk gene status, life style advise
Medical subject headings
Health Behavior, Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • information on the risk gene statusBehavioural

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

  • life style adviseBehavioural

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

Study groups in NCT03794141
Study groupRoleWhat they receive
TervasExperimentalFollow up group from an earlier study. Information on risk gene status. All test persons were given information on healthy diet and life style.
Receives: Behavioral: information on the risk gene status; Behavioral: life style advise
InformedExperimentalInformation on risk gene status was given before intervention. All test persons were given information on healthy diet and life style.
Receives: Behavioral: information on the risk gene status; Behavioral: life style advise
non informedActive comparatorInformation on risk gene status was not given before intervention. All test persons were given information on healthy diet and life style.
Receives: Behavioral: life style advise

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants with good quality of dietary fat

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

    Measured: 2 years

  2. 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

    Measured: 2 years

  3. Food choice questionnaire, health and taste attitude

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

    Measured: 2 years

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

    5 fully agree

    Measured: 2 years

  5. Health concern, scale 1-9

    1 not concerned at all

    Measured: 2 years

  6. Life-orientation test, scale 1-5

    1 fully agree

    Measured: 2 years

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

    4 fully agree

    Measured: 2 years

  8. weight kg

    Measured: 2 years

  9. height m

    Measured: 2 years

  10. Waist circumference, cm

    Measured: 2 years

  11. Visceral fat level (1-30)

    Measured: 2 years

  12. blood pressure, mmHg

    Measured: 2 years

  13. Serum lipid levels mmol/L

    Measured: 2 years

  14. Blood glucose levels, mmol/L

    Measured: 2 years

  15. Serum lipid peroxidation, MDA/µM

    Measured: 2 years

  16. Serum Sensitive C reactive protein, mg/L

    Measured: 2 years

  17. Serum Hemoglobin, g/L

    Measured: 2 years

  18. Serum Alkaline phosphatase, U/L

    Measured: 2 years

  19. Serum Alanine aminotransferase, U/L

    Measured: 2 years

  20. Serum haptoglobin, g/L

    Measured: 2 years

  21. Plasma thyrotropin, mU/L

    Measured: 2 years

  22. serum APOE protein, mg/L

    Measured: 2 years

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

    Measured: 2 years

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

    Measured: 2 years

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

    Measured: 2 years

  26. Blood cell count

    Measured: 2 years

  27. APOE and BDNF genotype

    Measured: baseline

Secondary outcomes (1)

  1. Body mass index

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

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jan 2019
  2. Study start2 Jan 2017
  3. Primary completion30 Mar 2019
  4. Study completion31 Jul 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
333 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03794141
Sponsor's protocol ID
41007-00040400
Acronym
APOE4MOT
Status last verified
Dec 2018
First submitted
13 Dec 2018
Last updated
26 Feb 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 33188400

Questions about this trial

What is this clinical trial studying?

A study testing information on the risk gene status and life style advise in people with Health Behavior and Alzheimer Disease, Protection Against, run by Natural Resources Institute Finland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with good quality of dietary fat (time frame: 2 years). The study lists 27 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03794141, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2020.

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