- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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.
Study Overview
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
all causes and specific cause mortality
Time Frame: up to 9 years of observatinal time
|
specific cause mortality = cancer and cardiovascular disease
|
up to 9 years of observatinal time
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- XXXX1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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