Healthy Fatty Acids in Transition (FAT)
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|ClinicalTrials.gov Identifier: NCT00937963|
Recruitment Status : Completed
First Posted : July 13, 2009
Last Update Posted : May 31, 2017
Diacylglycerol (DAG) is a molecule that consists of two fatty acid chains bound by ester links to a glycerol molecule, in the form of 1,2 and 1,3 structural isomers. Approximately 10% of the edible oils on today's market are comprised from DAG. DAG oil has a similar taste, appearance, and fatty acid composition as conventional triacylglycerol oil (TAG; consists of 3 fatty acids chains bound to a glycerol molecule), yet recent studies suggest that due to its different chemical structure, DAG oil may induce cardiovascular (CV) benefits. Specifically, human studies in the United States (US) and Japan have shown that long-term consumption of a diet containing DAG oil enhances loss of body weight and body fat compared with TAG oil of similar fatty acid composition. In postprandial studies, serum triglycerides (TG) and remnant like particle cholesterol concentrations, have shown to be lower following ingestion of DAG-enriched oil compared to conventional dietary oil (e.g., soybean, corn), or TAG oil. Therefore, DAG oil appears to be effective for preventing postprandial hyperlipidemia, which is a risk factor for arteriosclerosis.
The hypothesis that the investigators propose in this pilot study is that intake of DAG oil, compared to TAG oil will result in a lower LDL-C, and lower LDL-C/HDL-C ratio, as well as a reduction in TG levels. Given the significance of such findings, if confirmed, the investigators will evaluate other important clinical biomarkers for chronic disease (CV Disease, type 2 diabetes, metabolic syndrome), such as insulin sensitivity and inflammation [as determined by C-reactive protein (CRP), interleukin (IL)-1, IL-6 & tumor necrosis factor-alpha (TNF-α)], which also may be beneficially affected by consumption of the palm DAG oil. During the pilot study, the investigators will reserve serum/plasma samples so that these additional assays may be run upon approval of the modification.
|Condition or disease||Intervention/treatment||Phase|
|Cardiovascular Disease||Dietary Supplement: Palm DAG Oil||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Healthy FAT (Fatty Acids in Transition) Study|
|Study Start Date :||February 2009|
|Actual Primary Completion Date :||November 2009|
|Actual Study Completion Date :||November 2009|
Experimental: Palm Oil
Traditional palm oil normally used in foods
Dietary Supplement: Palm DAG Oil
Use of Palm DAG Oil to replace palm oil traditionally used in foods
- Lipoprotein profile (total cholesterol, LDL-C, HDL-C, TG) [ Time Frame: At the end of each 4 week diet period (week 4 and week 10) ]Participants receive a two week break between diet periods. Diet period 1 runs from week 1-4 and diet period 2 from week 7-10.
- Inflammatory markers (CRP, IL-1, IL-6 & TNF-α) [ Time Frame: At the end of each 4 week diet period (week 4 and week 10) ]
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): NCT00937963
|United States, Pennsylvania|
|Penn State University|
|University Park, Pennsylvania, United States, 16802|
|Principal Investigator:||Penny M Kris-Etherton, PhD||Penn State University|