Healthy Fatty Acids in Transition

NCT00937963 | Completed DMC

• 1 other identifier: PKE 103
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Disease

Keywords

cholesterol; cardiovascular; CVD; Triglycerides; Heart

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Inflammatory markers (CRP, IL-1, IL-6 & TNF-α)

  At the end of each 4 week diet period (week 4 and week 10)

Study Arms (1)

Palm Oil

EXPERIMENTAL

Traditional palm oil normally used in foods

Dietary Supplement: Palm DAG Oil

Interventions

Palm DAG Oil DIETARY_SUPPLEMENT

Use of Palm DAG Oil to replace palm oil traditionally used in foods

Palm Oil

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Penn State University: lead
• California Healthcare Institute: collaborator

Study Sites (1)

Penn State University

University Park, Pennsylvania, 16802, United States

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• Penny M Kris-Etherton, PhD

  Penn State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2009
• First Posted: July 13, 2009
• Study Start: February 1, 2009
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2009
• Last Updated: August 21, 2023

Record last verified: 2023-08

Locations

US (1)