Genetic Information as a Life Style Change Motivator

Health Behavior Clinical Trial

— APOE4MOT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03794141
• Other study ID #: 41007-00040400
• Status: Completed
• Phase: N/A
• Start date: January 2, 2017
• Est. completion date: July 31, 2019

Study information

• Verified date: December 2018
• Source: Natural Resources Institute Finland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 333
• Est. completion date: July 31, 2019
• Est. primary completion date: March 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer Disease, Protection Against
• Health Behavior

Intervention

Behavioral:
• information on the risk gene status
information on risk gene status (APOE4 allele or not) was given before intervention
• life style advise
all test persons were given information on healthy diet and life style

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Natural Resources Institute Finland	Academy of Finland, University of Eastern Finland, University of Turku

Outcome

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