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Healthy FAT (Fatty Acids in Transition) Study


N/A
30 Years
60 Years
Not Enrolling
Both
Cardiovascular Disease

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Trial Information

Healthy FAT (Fatty Acids in Transition) Study


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.


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)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Lipoprotein profile (total cholesterol, LDL-C, HDL-C, TG)

Outcome Description:

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.

Outcome Time Frame:

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

Safety Issue:

No

Principal Investigator

Penny M Kris-Etherton, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Penn State University

Authority:

United States: Institutional Review Board

Study ID:

PKE 103

NCT ID:

NCT00937963

Start Date:

February 2009

Completion Date:

November 2009

Related Keywords:

  • Cardiovascular Disease
  • cholesterol
  • cardiovascular
  • CVD
  • Triglycerides
  • Heart
  • Cardiovascular Diseases

Name

Location
Penn State University Hershey, Pennsylvania  17033