Effect of Trans Fatty Acids From Ruminant Sources on Risk Factors for Cardiovascular Disease
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Cardiovascular Disease |
Other: PHVO Other: CLA Other: VA Other: base |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) |
| Official Title: | Effect of Trans Fatty Acids From Ruminant Sources on Risk Factors for Cardiovascular Disease |
- LDL cholesterol [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 120 |
| Study Start Date: | February 2009 |
| Study Completion Date: | September 2009 |
| Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
-
Other: PHVO
Eligibility| Ages Eligible for Study: | 25 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
- Self-report of alcohol or substance abuse within the past twelve months and/or current acute treatment or rehabilitation program for these problems (long-term participation in Alcoholics Anonymous is not an exclusion).
- 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.
Contacts and Locations| United States, Maryland | |
| USDA-ARS, Beltsville Human Nutrition Research Center | |
| Beltsville, Maryland, United States, 20705 | |
| Principal Investigator: | David J Baer, Ph. D. | USDA-ARS |
More Information
No publications provided
| Responsible Party: | David J. Baer, Ph. D., Principal Investigator, USDA-ARS |
| ClinicalTrials.gov Identifier: | NCT00942656 History of Changes |
| Other Study ID Numbers: | 2006-293 |
| Study First Received: | July 17, 2009 |
| Last Updated: | February 8, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by USDA Beltsville Human Nutrition Research Center:
|
trans fatty acids ruminant cardiovascular disease |
Additional relevant MeSH terms:
|
Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 23, 2013