NCT03220139

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
18,372

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 1999

Longer than P75 for all trials

Status
completed

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 Start

First participant enrolled

January 1, 1999

Completed
12 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 6, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 18, 2017

Completed
Last Updated

July 19, 2017

Status Verified

July 1, 2017

Enrollment Period

12 years

First QC Date

July 6, 2017

Last Update Submit

July 17, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • all causes and specific cause mortality

    specific cause mortality = cancer and cardiovascular disease

    up to 9 years of observatinal time

Interventions

Observational study on fat intake and mortality

Eligibility Criteria

Age30 Years - 85 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Apparently healthy US adults age\>=30

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

July 6, 2017

First Posted

July 18, 2017

Study Start

January 1, 1999

Primary Completion

January 1, 2011

Study Completion

January 1, 2017

Last Updated

July 19, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will share