Healthy Fatty Acids in Transition (FAT)

Healthy FAT (Fatty Acids in Transition) Study

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Disease
• Intervention / Treatment: Dietary supplement: Palm DAG Oil

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
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • University Park, Pennsylvania, United States, 16802
      • Penn State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lipoprotein profile (total cholesterol, LDL-C, HDL-C, TG)	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.	At the end of each 4 week diet period (week 4 and week 10)

Secondary Outcome Measures

Outcome Measure	Time Frame
Inflammatory markers (CRP, IL-1, IL-6 & TNF-α)	At the end of each 4 week diet period (week 4 and week 10)

Collaborators and Investigators

• Sponsor: Penn State University
• Collaborators: California Healthcare Institute
• Investigators: Principal Investigator: Penny M Kris-Etherton, PhD, Penn State University

Study record dates

Study Major Dates

• Study Start: February 1, 2009
• Primary Completion (Actual): November 1, 2009
• Study Completion (Actual): November 1, 2009

Study Registration Dates

• First Submitted: June 18, 2009
• First Submitted That Met QC Criteria: July 10, 2009
• First Posted (Estimated): July 13, 2009

Study Record Updates

• Last Update Posted (Actual): August 21, 2023
• Last Update Submitted That Met QC Criteria: August 16, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Heart; cardiovascular; cholesterol; Triglycerides; CVD
• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: PKE 103