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临床试验/NCT07205978
NCT07205978进行中(未招募)不适用

Nut Consumption and Prevention of Non-communicable Diseases: A Global Individual Participant Data Meta-analysis

Institut Investigacio Sanitaria Pere Virgili2 个研究点 分布在 2 个国家目标入组 1,000,000 人开始时间: 2025年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
1,000,000
试验地点
2
主要终点
Type-2 diabetes incidence

研究概览

简要总结

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.

详细描述

NCDs account for 74% of global deaths, with 41% of these occurring prematurely in individuals aged 70 years and older. Type 2 diabetes, cardiovascular diseases (CVD), and cancer are among the major chronic diseases that affect people across countries and contribute to premature deaths. Notably, 77% of all NCD deaths and 86% of premature deaths occur in low- and middle-income countries. Reducing premature mortality from NCDs through preventive strategies, especially in low- and middle-income countries, was identified as a target in the Sustainable Development Goals from the World Health Organization. Additionally, as populations age, dementia is gaining recognition as a major public health concern. Dementia is among the leading causes of death and disability, with significant economic implications. Therefore, implementing preventive strategies to maintain cognitive function and delay cognitive decline is essential.

Adhering to a healthy diet is an effective and cost-efficient strategy to reduce NCDs. In fact, unhealthy diets have been linked to over 30% of NCDs and cognitive decline. Nuts are a common food component of several plant-based diets that have shown beneficial effects in preventing NCDs. Nuts are a diverse food group comprising a wide variety of oily kernels with a unique nutritional profile, including high amounts of protein, fiber, unsaturated fatty acids, vitamins, polyphenols, and other phytochemicals. These nutrients may contribute to their beneficial effects, such as antioxidant, anti-inflammatory, antihypertensive, anti-lipidemic, and anti-aging properties, as well as their potential positive influence on gut microbiota modulation.

Prior research has examined the impact of nuts on various health outcomes; however, many of these studies have focused on intermediate outcomes, obtained controversial results, and have been conducted primarily in European countries or the United States. Furthermore, the data has been analyzed using a variety of approaches, the studies were designed in different ways, and different covariates were added to the statistical models, potentially leading to inconsistencies and compromising the reliability of the comparison between studies. These inconsistencies emphasize the need for further research to elucidate the role of total nuts and specific types of nut consumption on the development of highly prevalent NCDs, as well as to allow the generalizability of the results across different countries and ethnicities.

In the NUTPOOL project, the objective is to address these knowledge gaps and provide a thorough assessment of the associations between total nuts and specific types of nuts in relation to a wide range of NCDs and mortality. The results from this global collaborative project will be representative of the worldwide populations, as they include prospective cohort studies from different countries, including not only American and European countries, but also Asian and Oceania. Additionally, the focus is on total and specific types of nuts, along with highly prevalent and relevant outcomes such as type 2 diabetes, cardiovascular disease (CVD), cancer, dementia, and mortality. To ensure consistency and reliability, the analyses will be standardized using Individual Participant Data (IPD) meta-analyses.

The selection of studies will be conducted after the identification of cohorts with data available on nut consumption. This identification process will be based on information comprehensively extracted from recently published systematic reviews and meta-analysis (SRMAs) on the subject, as well as through extensive research network. Invitations will be extended to as many eligible cohorts as possible to mitigate selection bias and ensure comprehensive participation in the study. Studies will be eligible for inclusion if they reported reliable nutrition data from a food frequency questionnaire (FFQ) regarding total nuts and/or specific nuts, along with well-defined data on at least two of the health outcomes. The study population had to be at least 1,000 adults, and the study had to span a minimum of five years or more of median follow-up, enabling time-dependent analyses.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Type-2 diabetes incidence

时间窗: Minimum of five years of median follow-up

Medical diagnosis, self-reported or medication check

CVD incidence

时间窗: Minimum of five years of median follow-up

Medical diagnosis, self-reported or medication check

Stroke incidence

时间窗: Minimum of five years of median follow-up

Medical diagnosis, self-reported or medication check

All-cause mortality rate

时间窗: Minimum of five years of median follow-up

National death registry, self-reported or medication check

Coronary health disesase incidence

时间窗: Minimum of five years of median follow-up

Medical diagnosis, self-reported or medication check

Total cancer incidence

时间窗: Minimum of five years of median follow-up

Medical diagnosis, self-reported or medication check

CVD-mortality rate,

时间窗: Minimum of five years of median follow-up

National death registry, self-reported or medication check

Cancer-mortality rate

时间窗: Minimum of five years of median follow-up

National death registry, self-reported or medication check

次要结局

  • 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)

研究者

发起方
Institut Investigacio Sanitaria Pere Virgili
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jordi Salas

Professor and Co-Prinicpal Investigator NUTPOOL

Institut Investigacio Sanitaria Pere Virgili

研究点 (2)

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