Diet ModificationNCT03220139
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
An observational study of Diet Modification, run by North-West University, South Africa.
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. Read more about this study
- Who is it for?
- Ages 30 to 85 years
- Conditions the study is for
- Diet Modification
- What is being tested?
- fat intake
- How many people
- 18,372 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 1999to 1 Jan 2017
- How long will I take part?
- 6 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 85 years
- All sexes
- Adult, Older adult
Study population: Apparently healthy US adults age>=30
Who may be able to join
- Included NHANES 1999-2010
- age >= 30 years old
Who cannot join
- Record not reported in the mortality linked file
- Cancer, type-II diabetes, cardiovascular disease at baseline
- Missing data on covariates used in the model
About this study
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.
- Conditions
- Diet Modification
- Being tested
- fat intake
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fat intakeOther
Observational study on fat intake and mortality
What is being measured
The primary outcome is the main question the study is designed to answer.
all causes and specific cause mortality
specific cause mortality = cancer and cardiovascular disease
Measured: up to 9 years of observatinal time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2017
- Study start1 Jan 1999
- Primary completion1 Jan 2011
- Study completion1 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diet ModificationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 18,372 participants (actual)
- Target duration
- 6 Years
Sponsor and investigators
- Lead sponsor
- North-West University, South Africa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cristian Ricci, North-West University, South Africa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03220139
- Sponsor's protocol ID
- XXXX1
- Status last verified
- Jul 2017
- First submitted
- 6 Jul 2017
- Last updated
- 19 Jul 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03220139
- Acronym / sponsor ID
- XXXX1
- Conditions
- Diet Modification
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18,372 participants (actual)
- Lead sponsor
- North-West University, South AfricaUniversity, hospital or other
- Study start
- 1 Jan 1999 (actual)
- Primary completion
- 1 Jan 2011 (actual)
- Study completion
- 1 Jan 2017 (actual)
- First posted
- 18 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Years
Who may qualify
- Ages
- 30 to 85 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Apparently healthy US adults age>=30
Key inclusion criteria (2 listed)
- Included NHANES 1999-2010
- age >= 30 years old
Key exclusion criteria (3 listed)
- Record not reported in the mortality linked file
- Cancer, type-II diabetes, cardiovascular disease at baseline
- Missing data on covariates used in the model
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fat intakeObservational study on fat intake and mortality | Other | – |
Primary outcome
all causes and specific cause mortality
Time frame: up to 9 years of observatinal time
specific cause mortality = cancer and cardiovascular disease
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2017.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Diet Modification, run by North-West University, South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
all causes and specific cause mortality (time frame: up to 9 years of observatinal time). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2017.