Genetic Information as a Life Style Change Motivator

NCT03794141 | Completed

• 1 other identifier: 41007-00040400
• Study Type: interventional
• Target: 333
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Health Behavior; Alzheimer Disease, Protection Against

Outcome Measures

Primary Outcomes (27)

• 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 Outcomes (1)

• Body mass index

  2 years

Study Arms (3)

Tervas

EXPERIMENTAL

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; Behavioral: life style advise

Informed

EXPERIMENTAL

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; Behavioral: life style advise

non informed

ACTIVE COMPARATOR

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

Interventions

information on the risk gene status BEHAVIORAL

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

Informed; Tervas

life style advise BEHAVIORAL

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

Informed; Tervas; non informed

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Natural Resources Institute Finland: lead
• University of Turku: collaborator
• University of Eastern Finland: collaborator
• Academy of Finland: collaborator

Related Publications (1)

• 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.

  PMID: 33188400 DERIVED

MeSH Terms

Conditions

Health Behavior; Alzheimer Disease

Condition Hierarchy (Ancestors)

Behavior; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Raija Tahvonen, Prof

  Natural Resources Institute Finland

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2018
• First Posted: January 4, 2019
• Study Start: January 2, 2017
• Primary Completion: March 30, 2019
• Study Completion: July 31, 2019
• Last Updated: February 26, 2020

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share