Acrylamide and Health Outcomes

NCT06224725 | Completed

• 1 other identifier: VR 2023-01801
• Study Type: observational
• Target: 1,700
• Locations: 1 country
• Sites: 1

Brief Summary

Acrylamide, a widespread food-processing contaminant, poses a major public health concern due to its high exposure level in the general population and its toxicity. While animal evidence shows that acrylamide causes neurological alterations and may play a role in cardiovascular disease, evidence in humans is lacking. Our project aims to investigate whether dietary acrylamide exposure, measured in blood, increases the risk of dementia, Alzheimer's and Parkinson's diseases and myocardial infarction. In addition, the aim is to improve the understanding of the biological mechanisms underlying these associations integrating small compounds in blood (i.e., OMICS). In two population-based cohorts, the Cohort of 60-Year-Olds and the Swedish Mammography Cohort, acrylamide will be assessed in blood samples using a case-cohort design (around 2145 individuals, 20-year follow-up). The results will be presented in four scientific publications using adequate data analysis. The project will run from 2024-2028. The project´s findings will help improve public health through safer food and better nutrition. If findings indicate that acrylamide increases the risk of these diseases, this will urge interventions to decrease acrylamide exposure via food production and consumption. In turn, this will help to reduce the burden of these diseases. Even findings showing null association will be equally relevant to avoid unnecessary and costly preventive measures.

Conditions

Dementia; Dementia Alzheimers; Parkinson Disease; Myocardial Infarction

Keywords

Dementia; Alzheimer Disease; Parkinson Disease; myocardial infarction; acrylamide; biomarkers

Outcome Measures

Primary Outcomes (3)

• Dementia (yes/no)

  Incident cases of dementia dementia (in Alzheimer´s disease, vascular, related to other disease, unspecified) including Alzheimer´s disease, other specified (including Lewis bodies) and unspecified neurodegenerative diseases using ICD codes version 10 as follows: F00-F03, G30, G31.8, G31.9. The cases will include participants free of any diagnosis of dementia investigated at the time of blood sampling (2004-2009 for SMC and 1997-1998 for 60YO). Incident cases of dementia will be identified through linkage to the Swedish National Cancer Register, National Patient Register, Swedish registry for cognitive/dementia disorders (SveDem) and Cause of Death Register till the end of follow-up (2022 for both cohorts).

  20 years

• Parkinson disease (yes/no)

  Parkinson´s disease, ICD codes version 10th: G20 The cases will include participants free of any diagnosis of Parkinson disease investigated at the time of blood sampling (2004-2009 for SMC and 1997-1998 for 60YO). Incident cases of Parkinson disease will be identified through linkage to the Swedish National Cancer Register, National Patient Register and Cause of Death Register till the end of follow-up (2022 for both cohorts).

  20 years

• Myocardial infarction (yes/no)

  Myocardial infarction, ICD code version 10th: I21. The cases will include participants free of any diagnosis of myocardial infarction investigated at the time of blood sampling (2004-2009 for SMC and 1997-1998 for 60YO). Incident cases of Parkinson disease will be identified through linkage to the Swedish National Cancer Register, National Patient Register and Cause of Death Register till the end of follow-up (2022 for both cohorts).

  20 years

Study Arms (2)

The Cohort of 60-year-olds (60YO): case-cohort study design

The project is an observational study and will employ a case-cohort design using two cohorts Swedish cohorts- The Cohort of 60-year-olds (60YO) and the Swedish Mammography Cohort (SMC). A sub-cohorts will be randomly selected from the full cohorts (aprox n = 450 around 5 %-of the baseline population in 1997-1999, for 60YO, and 2003-2009, for SMC). All the cases of each of the diseases under investigation occurring outside the sub-cohorts will be included. The cases will include participants free of any diagnosis of each of the diseases investigated at the time of sampling. Incident cases of the diseases under investigation will be identified through linkage to the Swedish National Cancer Register, National Patient Register, Cause of Death Register and Swedish registry for cognitive/dementia disorders till the end of follow-up (2022 for both cohorts).

Other: dietary acrylamide exposure measured via biomarkers in blood (hemoglobin adducts of acrylamide and glycidamide)

The Swedish Mammography Cohort (SMC)

A case-cohort design will be employed as for 60YO cohort (see cohort label "60YO")

Other: dietary acrylamide exposure measured via biomarkers in blood (hemoglobin adducts of acrylamide and glycidamide)

Interventions

dietary acrylamide exposure measured via biomarkers in blood (hemoglobin adducts of acrylamide and glycidamide) OTHER

Each of two acrylamide biomarkers will be modeled as continuous (per 10 pmol/g increment) and in categories (tertiles or quartiles) to assess potential nonlinear dose-response.

The Cohort of 60-year-olds (60YO): case-cohort study design; The Swedish Mammography Cohort (SMC)

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The project will be based on two relatively large Swedish population-based cohorts, The Cohort of 60-year-olds (60YO) and the Swedish Mammography Cohort (SMC). We will employ a case-cohort design. The 60YO includes 2,039 men and 2,193 women who during the period from July 1st, 1997, to June 30th, 1998, reached the age of 60 and resided in Stockholm County at the time of recruitment. Every third man and woman who fulfilled the inclusion criteria were invited to participate (https://ki-se.proxy.kib.ki.se/en/imm/the-cohort-of-60-year-olds). The SMC was initiated in 1987-1990, when all women residing in two counties in central Sweden (Uppsala or adjacent Västmanland county), born 1914-1948, were invited to the study (n = 90,303) by receiving a diet and lifestyle questionnaire (74% response rate). (https://www.simpler4health.se/).

You may qualify if:

• adults (18 years old)
• blood measured at the recruitment

You may not qualify if:

• prevalent cases of the diseases investigated

Sponsors & Collaborators

• Karolinska Institutet: lead
• Stockholm University: collaborator

Study Sites (1)

Karolinska Institutet

Stockholm, 17177, Sweden

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Whole blood for acrylamide biomarkers measuraments (acrylamide and glycidamide hemoglobin adducts) Whole blood samples will be collected (0.5 ml) from samples stored in freezer at -80°C at Uppsala University biobank, for the SMC, and at Karolinska Institutet (KI) biobank, for the 60YO, and sent to a certified laboratory in Stockholm. Briefly, the acrylamide and glycidamide hemoglobin adducts to N-terminal valine (AA-val and Gly-val, respectively) will be measured in blood by LC-MS based methods, representing the exposure during the lifespan of the erythrocyte. The case/control status of the samples will be unknown during the analysis. Laboratory batch will be adjusted for in all analyses.

MeSH Terms

Conditions

Dementia; Alzheimer Disease; Parkinson Disease; Myocardial Infarction

Interventions

Blood Specimen Collection; glycidamide

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Tauopathies; Neurodegenerative Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Federica Laguzzi

  Karolinska Instittutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 20 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 16, 2024
• First Posted: January 25, 2024
• Study Start: January 1, 2004
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: March 6, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Proposals may be submitted up to 36 months following article publication. After 36 months the data will be available in our University's data warehouse but without investigator support other than deposited metadata. Information regarding submitting proposals may be found at Clinical Trials. gov
• Access Criteria: Upon reasonable request

Locations

SE (1)