Healthy Fatty Acids in Transition (FAT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00937963
Recruitment Status : Completed
First Posted : July 13, 2009
Last Update Posted : May 31, 2017
California Healthcare Institute
Information provided by (Responsible Party):
Penny Kris-Etherton, Penn State University

Brief Summary:

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

Detailed Description:
Commonly consumed vegetable fats and oils are comprised predominantly of TAG, and small amounts of DAG and monoacylglycerol. TAG consists of 3 fatty acid ester, whereas diacylglycerol oil has 2 fatty acid esters linked to a glycerol backbone. Recently, Watanabe et al., 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. Thus, the effects of DAG oil on increasing LDL-C would be expected to be less than TAG oil.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Drug Information available for: Palm oil
U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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) ]

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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:

  • Smokers
  • A history of myocardial infarction, stroke, diabetes mellitus, liver disease, kidney disease, and thyroid disease (unless controlled on medication)
  • Lactation, pregnancy, or desire to become pregnant during the study
  • Cholesterol-lowering medications
  • Intake of putative cholesterol-lowering supplements (psyllium, fish oil capsules, soy lecithin, niacin, fiber, flax, and phytoestrogens, stanol/sterol supplemented foods)
  • Vegetarianism
  • Allergic to nuts (Other food allergies will be reviewed on a case-by-case basis)

Information from the National Library of Medicine

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 identifier (NCT number): NCT00937963

United States, Pennsylvania
Penn State University
University Park, Pennsylvania, United States, 16802
Sponsors and Collaborators
Penn State University
California Healthcare Institute
Principal Investigator: Penny M Kris-Etherton, PhD Penn State University

Responsible Party: Penny Kris-Etherton, Distinguished Professor of Nutrition, Penn State University Identifier: NCT00937963     History of Changes
Other Study ID Numbers: PKE 103
First Posted: July 13, 2009    Key Record Dates
Last Update Posted: May 31, 2017
Last Verified: May 2017

Keywords provided by Penny Kris-Etherton, Penn State University:

Additional relevant MeSH terms:
Cardiovascular Diseases