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OpenTrials
Completed

NCT Number: NCT03220139

Type of Dietary Fat Intakes in Relation to Mortality in US Adults: An Iso-caloric Substitution Analysis From the American National Health and Nutrition Examination Survey Linked to the US Mortality Registry

Background Cancer and cardiovascular diseases combined account for more than 50% of the overall mortality burden in the USA. Accumulating evidence indicates that saturated fat intake is related to an increase, while unsaturated fat intake is related to a decrease in all-causes mortality. Thus, current US dietary guidelines recommend a shift from saturated to unsaturated fat.

Objective The aim of the present study was to estimate the mortality risk reduction related to a dietary change from saturated fat to an equal amount of mono or polyunsaturated fat intake.

Design The American National health and nutrition examination surveys conducted between 1999 and 2010 were linked to the 2011 national US death registry resulting in an observational prospective mortality study. Proportional hazards Cox models were used to evaluate the association between saturated, mono-unsaturated and poly-unsaturated fat with all-cause, and cause specific mortality. Substitution analysis was conducted to estimate an iso-caloric substitution of 10% of the energy from dietary fat intake applied to the substitution of saturated fat with an equal amount of energy from mono-unsaturated or poly-unsaturated fat.

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Key information

Conditions

Age range

30 year–85 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Included NHANES 1999-2010
  • age >= 30 years old

Exclusion criteria

  • Record not reported in the mortality linked file
  • Cancer, type-II diabetes, cardiovascular disease at baseline
  • Missing data on covariates used in the model

Treatment and study plan

fat intake

Other

Observational study on fat intake and mortality

Primary outcomes

  1. all causes and specific cause mortality

    Time frame: up to 9 years of observatinal time

    specific cause mortality = cancer and cardiovascular disease

Sponsors and collaborators

Lead sponsor

North-West University, South Africa

Other

Registry information

Important dates

Study start
1999
Primary completion
2011
Study completion
2017
First posted
Jul 18, 2017
Registry last updated
Jul 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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