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临床试验/NCT03794141
NCT03794141已完成不适用

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

Natural Resources Institute Finland0 个研究点目标入组 333 人开始时间: 2017年1月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
333
主要终点
Health concern, scale 1-9

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
40 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

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

结局指标

主要结局

Health concern, scale 1-9

时间窗: 2 years

1 not concerned at all

Waist circumference, cm

时间窗: 2 years

blood pressure, mmHg

时间窗: 2 years

Serum lipid peroxidation, MDA/µM

时间窗: 2 years

Serum Alkaline phosphatase, U/L

时间窗: 2 years

serum Fatty acids, g/100g fatty acids

时间窗: 2 years

Food involvement and Food mavenism, scale 1-5

时间窗: 2 years

5 fully agree

Number of participants with good quality of dietary fat

时间窗: 2 years

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

Dietary habits, number of participants

时间窗: 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 week

Food choice questionnaire, health and taste attitude

时间窗: 2 years

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

Life-orientation test, scale 1-5

时间窗: 2 years

1 fully agree

height m

时间窗: 2 years

Visceral fat level (1-30)

时间窗: 2 years

Serum Sensitive C reactive protein, mg/L

时间窗: 2 years

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

时间窗: 2 years

4 fully agree

Serum lipid levels mmol/L

时间窗: 2 years

Blood glucose levels, mmol/L

时间窗: 2 years

weight kg

时间窗: 2 years

Serum Hemoglobin, g/L

时间窗: 2 years

Serum haptoglobin, g/L

时间窗: 2 years

Plasma thyrotropin, mU/L

时间窗: 2 years

serum APOE protein, mg/L

时间窗: 2 years

serum brain-derived neurotrophic factor, ng/ml

时间窗: 2 years

APOE and BDNF genotype

时间窗: baseline

Serum Alanine aminotransferase, U/L

时间窗: 2 years

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

时间窗: 2 years

Blood cell count

时间窗: 2 years

次要结局

  • Body mass index(2 years)

研究者

发起方
Natural Resources Institute Finland
申办方类型
Other Gov
责任方
Sponsor

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