NCT07205978

Brief Summary

The relationship between nut consumption and the risk of developing non-communicable diseases (NCDs) has been a subject of growing interest. However, the findings from previous studies have been conflicting for some health outcomes, such as type-2 diabetes, and have been underexplored for other outcomes, such as neurodegenerative diseases. One contributing factor to these inconsistencies lies in the different analytical approaches and confounding factors used across studies. Furthermore, the majority of previous studies have primarily focused on populations in Europe or the United States, potentially limiting the generalizability of the findings to other global regions. The NUTPOOL project aims to address these gaps by conducting an extensive individual participant data (IPD) meta-analysis. This study will evaluate the association between total and specific types of nut consumption and the future risk of NCDs.

Trial Health

78
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000,000

participants targeted

Target at P75+ for all trials

Timeline
9mo left

Started Oct 2025

Geographic Reach
2 countries

2 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress45%
Oct 2025Jan 2027

First Submitted

Initial submission to the registry

September 26, 2025

Completed
5 days until next milestone

Study Start

First participant enrolled

October 1, 2025

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 3, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2027

Last Updated

March 20, 2026

Status Verified

March 1, 2026

Enrollment Period

9 months

First QC Date

September 26, 2025

Last Update Submit

March 19, 2026

Conditions

Keywords

nutsmoratlitycardiovascular diseaseDiabetesdementiaIPDepidemiologyTree nutsPeanutswalnutsalmondspistachiosmacadamiacashewnutpine nutsBrazil nutsAdultType-2 diabetes, Diabetes Mellitus, type 1*Cardiovascular diseases*Coronary health disesaseAlzheimer disease*Parkinson disease*Mortality*Death*Fatal outcome*nut

Outcome Measures

Primary Outcomes (8)

  • Type-2 diabetes incidence

    Medical diagnosis, self-reported or medication check

    Minimum of five years of median follow-up

  • CVD incidence

    Medical diagnosis, self-reported or medication check

    Minimum of five years of median follow-up

  • Coronary health disesase incidence

    Medical diagnosis, self-reported or medication check

    Minimum of five years of median follow-up

  • Stroke incidence

    Medical diagnosis, self-reported or medication check

    Minimum of five years of median follow-up

  • Total cancer incidence

    Medical diagnosis, self-reported or medication check

    Minimum of five years of median follow-up

  • All-cause mortality rate

    National death registry, self-reported or medication check

    Minimum of five years of median follow-up

  • CVD-mortality rate,

    National death registry, self-reported or medication check

    Minimum of five years of median follow-up

  • Cancer-mortality rate

    National death registry, self-reported or medication check

    Minimum of five years of median follow-up

Secondary Outcomes (4)

  • Total dementia incidence

    Minimum of five years of median follow-up

  • Undefined dementia incidence

    Minimum of five years of median follow-up

  • Alzheimer's disease incidence

    Minimum of five years of median follow-up

  • Parkinson's disease incidence

    Minimum of five years of median follow-up

Study Arms (1)

The proposed aims will be evaluated using data from prospective cohort studies from around the world

Prospective studies will be eligible if they have good quality nutrition data from a food frequency questionnaire (FFQ) about total nuts and/or specific nuts, and well-ascertained data of at least two of the health outcomes (T2D, CVD, cancer, or dementia), more than 1,000 adult participants, and accrued five years or more of median follow-up that allows time-dependent analyses. We expect 25-30 cohorts to be included in the final analysis.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult participants from Cohorts larger than 5000 participants and with at least a mean of 5 years of follow-up

You may qualify if:

  • Prospective studies with:
  • Dietary data (consumption of nuts, both overall and/or by type) from semiquantitative food frequency questionnaires
  • Available data on at least two of the health outcomes of interest
  • More than 1,000 adult participants (aged 18 and over)
  • A minimum of five years of median follow-up

You may not qualify if:

  • Prospective studies determining the consumption of nuts in combination with other food groups (e.g., seeds) or with other nut forms (e.g., butter or oil)
  • Participants with:
  • Missing data on age, sex, and nut consumption.
  • Extreme energy intakes (\<600 or \>3,500 kcal for women and \<800 or \>4,200 kcal for men)
  • The disease of interest at baseline

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Public Health, Section of Epidemiology

Copenhagen, Denmark

Location

Human Nutrition Unit - Alimentació, Nutrició, Desenvolupament i Salut Mental (ANUT-DSM).

Reus, Catalonia, 43201, Spain

Location

MeSH Terms

Conditions

Diabetes MellitusNeoplasmsDementiaAlzheimer DiseaseParkinson DiseaseDeathCardiovascular Diseases

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental DisordersTauopathiesNeurodegenerative DiseasesParkinsonian DisordersBasal Ganglia DiseasesMovement DisordersSynucleinopathiesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Co-Prinicpal Investigator NUTPOOL

Study Record Dates

First Submitted

September 26, 2025

First Posted

October 3, 2025

Study Start

October 1, 2025

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

January 30, 2027

Last Updated

March 20, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Individual cohorts only send summary data as per the harmonised analysis plan to the study leads. Therefore, the individual participant data remain with the individual cohorts.

Locations