Genetic Information as a Life Style Change Motivator

NCT ID: NCT03794141

Last Updated: 2020-02-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

333 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-02

Study Completion Date

2019-07-31

Brief Summary

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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

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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.

Conditions

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Health Behavior Alzheimer Disease, Protection Against

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

information on the risk gene status

Intervention Type BEHAVIORAL

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

life style advise

Intervention Type BEHAVIORAL

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

Informed

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

Group Type EXPERIMENTAL

information on the risk gene status

Intervention Type BEHAVIORAL

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

life style advise

Intervention Type BEHAVIORAL

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

non informed

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

Group Type ACTIVE_COMPARATOR

life style advise

Intervention Type BEHAVIORAL

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

Interventions

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information on the risk gene status

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

Intervention Type BEHAVIORAL

life style advise

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Turku

OTHER

Sponsor Role collaborator

University of Eastern Finland

OTHER

Sponsor Role collaborator

Academy of Finland

OTHER

Sponsor Role collaborator

Natural Resources Institute Finland

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Raija Tahvonen, Prof

Role: STUDY_DIRECTOR

Natural Resources Institute Finland

References

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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.

Reference Type DERIVED
PMID: 33188400 (View on PubMed)

Other Identifiers

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41007-00040400

Identifier Type: -

Identifier Source: org_study_id

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