Genetic Information as a Life Style Change Motivator
- Conditions
- Alzheimer Disease, Protection AgainstHealth Behavior
- Interventions
- Behavioral: information on the risk gene statusBehavioral: life style advise
- Registration Number
- NCT03794141
- Lead Sponsor
- Natural Resources Institute Finland
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 333
- 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.
- Abnormal values of the alanine amino transferase, alkaline phosphatase, haptoglobin and thyroid stimulating hormone
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Tervas information on the risk gene status Follow up group from an earlier study. Information on risk gene status. All test persons were given information on healthy diet and life style. Informed information on the risk gene status Information on risk gene status was given before intervention. All test persons were given information on healthy diet and life style. Informed life style advise Information on risk gene status was given before intervention. All test persons were given information on healthy diet and life style. Tervas life style advise Follow up group from an earlier study. Information on risk gene status. All test persons were given information on healthy diet and life style. non informed life style advise Information on risk gene status was not given before intervention. All test persons were given information on healthy diet and life style.
- Primary Outcome Measures
Name Time Method serum APOE protein, mg/L 2 years serum brain-derived neurotrophic factor, ng/ml 2 years APOE and BDNF genotype baseline Serum Alanine aminotransferase, U/L 2 years Health concern, scale 1-9 2 years 1 not concerned at all
Waist circumference, cm 2 years serum Fatty acids, g/100g fatty acids 2 years Serum haptoglobin, g/L 2 years Plasma thyrotropin, mU/L 2 years blood pressure, mmHg 2 years Serum lipid peroxidation, MDA/µM 2 years Serum Alkaline phosphatase, U/L 2 years Food involvement and Food mavenism, scale 1-5 2 years 5 fully agree
Number of participants with good quality of dietary fat 2 years A questionnaire according to Finnish guidelines of Suomen Sydänliitto ry, Helldán \& Helakorpi, (2015)
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 weekFood choice questionnaire, health and taste attitude 2 years Scale 1-7 (7 most important, fully agree)
Life-orientation test, scale 1-5 2 years 1 fully agree
height m 2 years Visceral fat level (1-30) 2 years Serum Sensitive C reactive protein, mg/L 2 years Locus of Control, state-trait anxiety inventory, Three-Factor Eating Questionnaire (TFEQ) scale 1-4 2 years 4 fully agree
Serum lipid levels mmol/L 2 years Blood glucose levels, mmol/L 2 years weight kg 2 years Serum Hemoglobin, g/L 2 years serum Carotenoids, retinol and α-tocopherol, Plasma total phenolics ng/µl 2 years Blood cell count 2 years
- Secondary Outcome Measures
Name Time Method Body mass index 2 years weight and height will be combined to report BMI in kg/m\^2