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Dietary Fats and Biomarkers of Human Health: Excess Saturated Fat or Lack of Omega 3 Fatty Acids (Second Chronic Study)

Would it be an excess of saturated fat in the diet or a deficiency of omega-3 fatty acids the responsible for increased blood lipid levels? And what would be the effect of the background diet in healthy adults consuming adequate omega-3 Polyunsaturated fatty acids?

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12614001051639
Acronym
Nil
Enrollment
38
Registered
2014-10-02
Start date
2014-09-24
Completion date
2015-06-22
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Consumption of foods rich in saturated fats have been associated with elevated blood lipid levels and adverse health effects. However studies using animal models have demonstrated that dietary saturated fats raise blood lipid (cholesterol and triglyceride) levels only when the diet is deficient in omega-3 fatty acids (n-3PUFA). If the same is true for humans, this research will have important implications for the prevention of cardiovascular disease and other chronic diseases. Therefore we hypothesize that saturated fat consumption does not raise blood lipid levels if the diet is sufficient in n-3PUFA. We also hypothesize that the benefits of n-3PUFA can be optimized when consumed in combination with saturated fats. This is a randomized controlled, dietary intervention trial, in parallel design with healthy adults. Subjects will be asked to consume 4x1g fish oil capsules (2.4g EPA:DHA 100:500) daily for 4 weeks, then they will be randomly assigned to one of two diets, a high saturated fat (SFA) diet or a high omega-6 fatty acid (n-6PUFA) diet both combined with n-3PUFA (fish oil), which they will consume for 10 days. Subjects on the SFA diet will consume daily 24g butter (which can be spread on bread, muffins or crackers), 40g white chocolate and 4x1g fish oil capsules, they will also be advised on how to use more foods containing saturated fat for cooking and reduce n-6PUFA containing oils. Subjects on the n-6PUFA diet will consume 20g margarine (which can be spread on bread, muffins or crackers), 42g sunflower seeds and 4x1g fish oil capsules, they will also be advised on how to use more foods and oils containing n-6PUFA for cooking, and reduce saturated fat. Participants will donate blood, give information on medical and supplement usage and physical activity and they will have their anthropometric measurements taken, at baseline, at 4 weeks and after 10 day of consuming either the SFA diet or the n-6PUFA diet. Subjects will also complete a 3 day food record.

Interventions

Subjects will be asked to consume 4x1g fish oil capsules (2.4g EPA:DHA 100:500) daily for 4 weeks; then they will be randomly assigned to one of two diets, either a high saturated fat (SFA) diet or a high n-6PUFA diet, both combined with n-3PUFA (fish oil), which they will consume for 10 days. Subjects on the saturated fat diet will consume daily 24g butter (which can be spread on bread, muffins or crackers), 40g white chocolate and 4x1g fish oil capsules; they will also be advised on how to use

Subjects will be asked to consume 4x1g fish oil capsules (2.4g EPA:DHA 100:500) daily for 4 weeks; then they will be randomly assigned to one of two diets, either a high saturated fat (SFA) diet or a high n-6PUFA diet, both combined with n-3PUFA (fish oil), which they will consume for 10 days. Subjects on the saturated fat diet will consume daily 24g butter (which can be spread on bread, muffins or crackers), 40g white chocolate and 4x1g fish oil capsules; they will also be advised on how to use more foods containing saturated fat for cooking and reduce n-6PUFA containing oils. The patients will donate blood, give information on medical and supplement usage and physical activity and they will have their anthropometric measurements taken, at baseline, at 4 weeks and after 10 days of consuming the SFA diet. Subjects will also complete a 3 day food record, at baseline, at 4 weeks and after 10 days of consuming the SFA diet.

Sponsors

University of Newcastle
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

Healthy male or female aged between 18 and 65 years at initial assessment

Exclusion criteria

Participants will be excluded from the study if they satisfy any of the following criteria: Are currently using lipid-lowering drugs (eg statins), fish oil supplements or anti-inflamatory drugs; Have a current regular consumption of 2 or more fish meals a week; Have history of congestive heart failure, stroke, myocardial infarction, coronary artery bypass graft, or atherosclerotic CVD; Have history of diabetes triglycerides higher than 10 mmol/L; LDL cholesterol higher than 5 mmol/L; Have history of gastrointestinal disorder Have history of liver disease; Are current smokers; Are pregnant or breast feeding women

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026