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

Diet Modification Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03220139
• Other study ID #: XXXX1
• Status: Completed
• Phase: N/A
• First received: July 6, 2017
• Last updated: July 17, 2017
• Start date: January 1, 1999
• Est. completion date: January 1, 2017

Study information

• Verified date: July 2017
• Source: North-West University, South Africa
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18372
• Est. completion date: January 1, 2017
• Est. primary completion date: January 1, 2011
• Gender: All
• Age group: 30 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Diet Modification

Intervention

Other:
• fat intake
Observational study on fat intake and mortality

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
North-West University, South Africa

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	all causes and specific cause mortality	specific cause mortality = cancer and cardiovascular disease	up to 9 years of observatinal time