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Healthy Fatty Acids in Transition


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  • Purpose

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    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 (see diagram below). Approximately 10% of the edible oils on today's market are comprised from DAG (5).
    DAG oil (containing > 80% DAG) 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 (6,7). 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 the modified fat (palm DAG oil), compared to the parent fat 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.


      status: recruiting
      conditions: Cardiovascular Disease
      interventions: Palm DAG Oil
      phase: N/A
      study type: Interventional
      study design: Treatment, Randomized, Open Label, Crossover Assignment, Efficacy Study
      official title: Healthy FAT (Fatty Acids in Transition) Study

    • Further study details (as provided by Penn State University)

      primary outcome measures:

      • Lipoprotein profile (total cholesterol, LDL-C, HDL-C, TG) [ Time Frame: End of each diet period ]

      secondary outcome measures:

      • Inflammatory markers (CRP, IL-1, IL-6 & TNF-α) [ Time Frame: End of each diet period ]

      enrollment: 20

      study start date: February 2009

      study completion date: October 2009


      Arms Assigned Interventions

      Palm Oil: Experimental

      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

      Detailed description

      Commonly consumed vegetable fats and oils are comprised predominantly of TAG, and small amounts of DAG and monoacylglycerols (5). TAG consists of 3 fatty acid ester, whereas diacylglycerol oil has 2 fatty acid esters linked to a glycerol backbone. Recently, Watanabe et al., (10) developed a process by which the ratio of glycerides found in plant oils such as soybean, canola (rapeseed), or corn can be shifted from TAG to DAG, leading to the formation of oil composed largely of DAG. Commercially, DAG oil is produced by esterification of fatty acids derived from natural edible plant oils in the presence of lipase enzyme. Commercially produced vegetable DAG oil contains >80% DAG, <20% TAG, <5% monoacylglycerols, and small amounts of emulsifiers and antioxidants to maintain quality.
      The main constituent fatty acids of DAG oil are oleic (C18:1), linoleic (C18:2), and linolenic (C18:3) acids, present as 1,3- and 1,2 (or 2,3)-DAGs in a ratio of 7:3, respectively.
      These structural differences may be responsible for the purported metabolic effects of DAG compared to TAG oil, DAG oil has fewer fatty acids than TAG, and DAG-oil with a greater proportion of DAG in the sn-1,3 versus sn-1,2 form may be more readily oxidized. Due to the high concentration of saturated fatty acids, palm oil is solid at room temperature, and consumption of palm oil has been shown to increase low-density lipoprotein cholesterol (LDL--C) levels in humans (11).
      Collectively, many studies have shown that saturated fatty acids have a LDL-C/HDL-C raising effect. Converting palm TAG oil to palm DAG oil, of which 70% would be DAG in the sn-1,3 form, will reduce total saturated fatty acids by about one-third. Thus, the effects of palm DAG oil on increasing LDL-C would be expected to be less than palm oil. Palm DAG oil would be expected to raise the LDL-C/high-density lipoprotein cholesterol (HDL-C) less than the native oils.

    • Eligibility

      ages eligible for study: 30 Years to 60 Years
      genders eligible for study: Both

      Criteria

      Inclusion Criteria:
      • 30-60 years of age
      • Moderately elevated LDL-C (120-175 mg/dL) and normal HDL-C (30-50 mg/dL)
      • TG < 350 mg/dL

      Exclusion Criteria:

    • Contacts and locations

      Please refer to this study by its ClinicalTrials.gov identifier: NCT00937963

      Contacts

      Jennifer A Fleming, M.S.   814-863-8056   jas58@psu.edu

      Locations

      United States , Pennsylvania  - Penn State University

      status: recruiting
      facility: University Park, Pennsylvania, United States, 16802

    • Sponsors and collaborators

      Penn State University
      Abunda Corporation

      investigators: Penny M Kris-Etherton, PhD, Principal Investigator, Penn State University

    • More information

      first received: June 18, 2009
      last updated: July 10, 2009
      ClinicalTrials.gov Identifier: NCT00937963
      health authority: United States: Institutional Review Board

    Information obtained from ClinicalTrials.gov on September 25, 2009   Link to the current ClinicalTrials.gov record.

© 2009 NextBio