Effect of Trans Fatty Acids From Ruminant Sources on Risk Factors for Cardiovascular Disease

NCT00942656 | Completed DMC

• 1 other identifier: 2006-293
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The objectives of this study are to : 1) determine if vaccenic acid (trans-11-octadecenoic, a naturally occurring trans fatty acid isomer from ruminant animal products) raises LDL cholesterol in a quantitatively comparable manner as mixed trans fatty acid isomers from partially hydrogenated vegetable oils at 3% of energy intake, 2) determine if cis-9, trans-11 conjugated linoleic acid (a naturally occurring polyunsaturated fatty acid from ruminant animal products) raises LDL cholesterol compared to a control diet, and 3) demonstrate that mixed trans fatty acid isomers from partially hydrogenated vegetable oil raises LDL cholesterol compared to a low trans fatty acid diet.

Conditions

Cardiovascular Disease

Keywords

trans fatty acids; ruminant; cardiovascular disease

Outcome Measures

Primary Outcomes (1)

• LDL cholesterol

  4 weeks

Interventions

PHVO OTHER

base diet plus 3.0% energy mixed isomers of trans fatty acids from partially hydrogenated vegetable oil

CLA OTHER

base diet plus 1.0% energy added from cis-9, trans-11 conjugated linoleic acid

VA OTHER

base diet plus 3.0% energy added from vaccenic acid

base OTHER

base diet containing approximately 0.1% energy of mixed trans fatty acid isomers

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• BMI between 20 and 38 kg/m2
• Age 25 to 65 years during the intervention
• Fasting glucose \< 126 mg/dl
• Blood pressure \< 160/100 mm Hg (controlled with certain medications)
• Total plasma cholesterol \< 280 mg/dl
• Fasting triglycerides \< 300 mg/dl

You may not qualify if:

• Use of prescription or over-the-counter medications or supplements that alter lipid metabolism.
• History or presence of kidney disease, liver disease, gout, certain cancers, thyroid disease, gastrointestinal, other metabolic diseases, or malabsorption syndromes.
• Type 2 diabetes requiring the use of oral antidiabetic agents or insulin.
• History of eating disorders or other dietary patterns which are not consistent with the dietary intervention (e.g., vegetarians, very low fat diets, high protein diets).
• Women who have given birth during the previous 12 months, pregnant women, women who plan to become pregnant or who become pregnant during the study or lactating women.
• Volunteers who routinely participate in heavy exercise or volunteers who initiate an exercise program during the study.
• Volunteers who have lost 10% of body weight within the last 12 months or who plan to initiate a weight loss program during the next 10 months.
• Use of prescription or over-the-counter antiobesity medications or supplements (e.g., phenylpropanolamine, ephedrine, caffeine, during and for at least 6 months prior to the start of the study) or history of a surgical intervention for obesity.
• Active cardiovascular disease (such as heart attack or procedure within the past three months or participation in a cardiac rehabilitation program within last three months, stroke or history/treatment for transient ischemic attacks in the past three months, or documented history of pulmonary embolus in past six months).
• Smokers or other tobacco users (during the 6 months prior to the start of the study).
• Unable or unwilling to give informed consent or communicate with study staff.
• Other medical, psychiatric, or behavioral factors that in the judgment of the Principal Investigator may interfere with study participation or the ability to follow the intervention protocol.

Sponsors & Collaborators

• United States Department of Agriculture (USDA): lead

Study Sites (1)

USDA-ARS, Beltsville Human Nutrition Research Center

Beltsville, Maryland, 20705, United States

Location

Related Publications (1)

• Gebauer SK, Destaillats F, Dionisi F, Krauss RM, Baer DJ. Vaccenic acid and trans fatty acid isomers from partially hydrogenated oil both adversely affect LDL cholesterol: a double-blind, randomized controlled trial. Am J Clin Nutr. 2015 Dec;102(6):1339-46. doi: 10.3945/ajcn.115.116129. Epub 2015 Nov 11.

  PMID: 26561632 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Alkalies

Intervention Hierarchy (Ancestors)

Inorganic Chemicals

Study Officials

• David J Baer, Ph. D.

  United States Department of Agriculture (USDA)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: CROSSOVER
• Sponsor Type: FED

Study Record Dates

• First Submitted: July 17, 2009
• First Posted: July 21, 2009
• Study Start: February 1, 2009
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: February 9, 2011

Record last verified: 2011-02

Locations

US (1)