Genetic Information as a Life Style Change Motivator (APOE4MOT)

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.

Study Overview

• Status: Completed
• Conditions: Health Behavior; Alzheimer Disease, Protection Against
• Intervention / Treatment: Behavioral: information on the risk gene status; Behavioral: life style advise

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 Type: Interventional
• Enrollment (Actual): 333
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with good quality of dietary fat	A questionnaire according to Finnish guidelines of Suomen Sydänliitto ry, Helldán & Helakorpi, (2015)	2 years
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	2 years
Food choice questionnaire, health and taste attitude	Scale 1-7 (7 most important, fully agree)	2 years
Food involvement and Food mavenism, scale 1-5	5 fully agree	2 years
Health concern, scale 1-9	1 not concerned at all	2 years
Life-orientation test, scale 1-5	1 fully agree	2 years
Locus of Control, state-trait anxiety inventory, Three-Factor Eating Questionnaire (TFEQ) scale 1-4	4 fully agree	2 years
weight kg		2 years
height m		2 years
Waist circumference, cm		2 years
Visceral fat level (1-30)		2 years
blood pressure, mmHg		2 years
Serum lipid levels mmol/L		2 years
Blood glucose levels, mmol/L		2 years
Serum lipid peroxidation, MDA/µM		2 years
Serum Sensitive C reactive protein, mg/L		2 years
Serum Hemoglobin, g/L		2 years
Serum Alkaline phosphatase, U/L		2 years
Serum Alanine aminotransferase, U/L		2 years
Serum haptoglobin, g/L		2 years
Plasma thyrotropin, mU/L		2 years
serum APOE protein, mg/L		2 years
serum brain-derived neurotrophic factor, ng/ml		2 years
serum Fatty acids, g/100g fatty acids		2 years
serum Carotenoids, retinol and α-tocopherol, Plasma total phenolics ng/µl		2 years
Blood cell count		2 years
APOE and BDNF genotype		baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body mass index	weight and height will be combined to report BMI in kg/m^2	2 years

Collaborators and Investigators

• Sponsor: Natural Resources Institute Finland
• Collaborators: University of Turku; University of Eastern Finland; Academy of Finland
• Investigators: Study Director: Raija Tahvonen, Prof, Natural Resources Institute Finland

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2017
• Primary Completion (Actual): March 30, 2019
• Study Completion (Actual): July 31, 2019

Study Registration Dates

• First Submitted: December 13, 2018
• First Submitted That Met QC Criteria: January 2, 2019
• First Posted (Actual): January 4, 2019

Study Record Updates

• Last Update Posted (Actual): February 26, 2020
• Last Update Submitted That Met QC Criteria: February 25, 2020
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease
• Other Study ID Numbers: 41007-00040400

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No