The Effects of Natural Versus Man-Made Trans Fatty Acids on Lipoprotein Profiles: A Pilot Study
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|ClinicalTrials.gov Identifier: NCT00535886|
Recruitment Status : Completed
First Posted : September 26, 2007
Last Update Posted : May 7, 2008
|Condition or disease||Intervention/treatment||Phase|
|Cardiovascular Disease Diabetes Dyslipidemia||Dietary Supplement: Man-made Trans FA Dietary Supplement: Natural Trans FA Dietary Supplement: Oleic Acid||Not Applicable|
Since the purpose of the study is to determine the statistical power required for a definitive study testing and comparing the effects of two trans fatty acids, vaccenic and elaidic acid, on lipoprotein profiles, no hypotheses will be specified.
- To determine the variability in the lipid and lipoprotein response to diets enriched in natural versus man-made trans fats in order to appropriately power a larger scale clinical study
- To optimize the delivery of trans fat-enriched diets through the development of supplemental food items
The adverse health effects of trans fatty acids (TFA) on cardiovascular disease (CVD) risk have been established in a number of metabolic and epidemiological studies [Willett 1993, Hu 1997, Ascherio 1996, Pietinen 1997, Oomen 2001]. Trans fats are fatty acids with 18 carbon chains and one or more double bond(s). The hydrogen atoms of the double bond(s) are in a configuration (trans rather than cis) that results in the straightening of a normally kinked unsaturated fatty acid chain. Trans fats occur naturally in low quantities in dairy and beef products, but have also been artificially introduced to the food supply by the process of the hydrogenation of vegetable oils [Mann 1994]. Only two studies linking the consumption of trans fatty acids with an increased risk of CVD have distinguished between the effects of man-made versus naturally occurring trans fatty acids [Willett 1993, Oomen 2001].
It has been suggested that the relationship between trans fatty acids and coronary heart disease is specifically attributable to man-made trans fatty acids. In fact, some of the trans fats that occur naturally in animal products, in particular, conjugated linoleic acid (CLA), may have beneficial health effects. CLA has been shown to be anti-carcinogenic [Ip 2003], anti-atherogenic [McLeod 2004] and anti-diabetic [Rainer 2004]; it has also been shown to enhance the immune response and have positive effects on growth and energy partitioning. As a precursor to CLA, vaccenic acid (VA), another trans fatty acid found in dairy and beef products, may also provide health benefits. Bioconversion of VA to CLA has been recently demonstrated [Turpeinen 2002]. The effects of diet supplementation with VA on health parameters have yet to be defined.
The objective of the overall research project will be to test the hypothesis that the ingestion of high doses of naturally occurring VA does not cause the adverse lipid and lipoprotein effects known to occur with the consumption of man made trans fatty acids, in particular, elaidic acid (EA). The latter is the primary trans fatty acid found in products such as margarines, cakes, cookies, crackers and other baked and processed foods [Steinhart 2003]. The primary outcome measure will be the ratio of total to high density lipoprotein (HDL) cholesterol. Related secondary outcome measures include concentrations of low density lipoprotein (LDL) cholesterol, HDL cholesterol, triglyceride (TG) and Lp(a). The present proposal is designed to test the feasibility of, and determine the power for, a definitive study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||The Effects of Natural Versus Man-Made Trans Fatty Acids on Lipoprotein Profiles: A Pilot Study|
|Study Start Date :||November 2005|
|Actual Study Completion Date :||April 2006|
|Active Comparator: Elaidic Acid||
Dietary Supplement: Man-made Trans FA
EA as 6% of total energy
|Experimental: Vaccenic Acid||
Dietary Supplement: Natural Trans FA
VA as 6% of total energy
|Placebo Comparator: Oleic Acid||
Dietary Supplement: Oleic Acid
OA as 6% of total energy
- The primary outcome measure will be the ratio of total to high density lipoprotein (HDL) cholesterol. Blood draws will take place at screening, three weeks, and five weeks. [ Time Frame: Five weeks ]
- Related secondary outcome measures include concentrations of low density lipoprotein (LDL) cholesterol, HDL cholesterol, triglyceride (TG) and Lp(a) measured at screening, three weeks, and five weeks. [ Time Frame: Five weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00535886
|United States, California|
|Children's Hospital Oakland Research Institute|
|Oakland, California, United States, 94609|
|Principal Investigator:||Ronald M Krauss, M.D.||Children's Hospital & Research Center Oakland|
|Study Director:||Patty Siri, Ph.D.||Children's Hospital & Research Center Oakland|
|Study Director:||Shira Miller, M.D.||National Cattlemen's Beef Association|