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Trial record 33 of 37 for:    conjugated linoleic acid

The Effects of Natural Versus Man-Made Trans Fatty Acids on Lipoprotein Profiles: A Pilot Study

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ClinicalTrials.gov Identifier: NCT00535886
Recruitment Status : Completed
First Posted : September 26, 2007
Last Update Posted : May 7, 2008
Sponsor:
Collaborator:
National Cattlemen's Beef Association
Information provided by:
UCSF Benioff Children’s Hospital Oakland

Tracking Information
First Submitted Date  ICMJE September 21, 2007
First Posted Date  ICMJE September 26, 2007
Last Update Posted Date May 7, 2008
Study Start Date  ICMJE November 2005
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: September 21, 2007)
The primary outcome measure will be the ratio of total to high density lipoprotein (HDL) cholesterol. Blood draws will take place at screening, three weeks, and five weeks. [ Time Frame: Five weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00535886 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 21, 2007)
Related secondary outcome measures include concentrations of low density lipoprotein (LDL) cholesterol, HDL cholesterol, triglyceride (TG) and Lp(a) measured at screening, three weeks, and five weeks. [ Time Frame: Five weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effects of Natural Versus Man-Made Trans Fatty Acids on Lipoprotein Profiles: A Pilot Study
Official Title  ICMJE The Effects of Natural Versus Man-Made Trans Fatty Acids on Lipoprotein Profiles: A Pilot Study
Brief Summary The purpose of this study is to test the effects of natural vs. man-made trans fatty acids (trans fats) on blood cholesterol.
Detailed Description

Since the purpose of the study is to determine the statistical power required for a definitive study testing and comparing the effects of two trans fatty acids, vaccenic and elaidic acid, on lipoprotein profiles, no hypotheses will be specified.

Specific Aims:

  1. To determine the variability in the lipid and lipoprotein response to diets enriched in natural versus man-made trans fats in order to appropriately power a larger scale clinical study
  2. To optimize the delivery of trans fat-enriched diets through the development of supplemental food items

The adverse health effects of trans fatty acids (TFA) on cardiovascular disease (CVD) risk have been established in a number of metabolic and epidemiological studies [Willett 1993, Hu 1997, Ascherio 1996, Pietinen 1997, Oomen 2001]. Trans fats are fatty acids with 18 carbon chains and one or more double bond(s). The hydrogen atoms of the double bond(s) are in a configuration (trans rather than cis) that results in the straightening of a normally kinked unsaturated fatty acid chain. Trans fats occur naturally in low quantities in dairy and beef products, but have also been artificially introduced to the food supply by the process of the hydrogenation of vegetable oils [Mann 1994]. Only two studies linking the consumption of trans fatty acids with an increased risk of CVD have distinguished between the effects of man-made versus naturally occurring trans fatty acids [Willett 1993, Oomen 2001].

It has been suggested that the relationship between trans fatty acids and coronary heart disease is specifically attributable to man-made trans fatty acids. In fact, some of the trans fats that occur naturally in animal products, in particular, conjugated linoleic acid (CLA), may have beneficial health effects. CLA has been shown to be anti-carcinogenic [Ip 2003], anti-atherogenic [McLeod 2004] and anti-diabetic [Rainer 2004]; it has also been shown to enhance the immune response and have positive effects on growth and energy partitioning. As a precursor to CLA, vaccenic acid (VA), another trans fatty acid found in dairy and beef products, may also provide health benefits. Bioconversion of VA to CLA has been recently demonstrated [Turpeinen 2002]. The effects of diet supplementation with VA on health parameters have yet to be defined.

The objective of the overall research project will be to test the hypothesis that the ingestion of high doses of naturally occurring VA does not cause the adverse lipid and lipoprotein effects known to occur with the consumption of man made trans fatty acids, in particular, elaidic acid (EA). The latter is the primary trans fatty acid found in products such as margarines, cakes, cookies, crackers and other baked and processed foods [Steinhart 2003]. The primary outcome measure will be the ratio of total to high density lipoprotein (HDL) cholesterol. Related secondary outcome measures include concentrations of low density lipoprotein (LDL) cholesterol, HDL cholesterol, triglyceride (TG) and Lp(a). The present proposal is designed to test the feasibility of, and determine the power for, a definitive study.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Condition  ICMJE
  • Cardiovascular Disease
  • Diabetes
  • Dyslipidemia
Intervention  ICMJE
  • Dietary Supplement: Man-made Trans FA
    EA as 6% of total energy
  • Dietary Supplement: Natural Trans FA
    VA as 6% of total energy
  • Dietary Supplement: Oleic Acid
    OA as 6% of total energy
Study Arms  ICMJE
  • Active Comparator: Elaidic Acid
    Intervention: Dietary Supplement: Man-made Trans FA
  • Experimental: Vaccenic Acid
    Intervention: Dietary Supplement: Natural Trans FA
  • Placebo Comparator: Oleic Acid
    Intervention: Dietary Supplement: Oleic Acid
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 21, 2007)
15
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2006
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male
  • Age >= 18 years
  • Body mass index (BMI) less than 35 kg/m*m
  • Fasting total cholesterol and LDL cholesterol less than the 95% for age and sex
  • Fasting triglyceride <= 400 mg/dl
  • Fasting blood glucose <= 125 mg/dl
  • Fasting thyroid stimulating hormone less than 0.3 or greater than 5.0 uIU/ml
  • Blood pressure <= 150/90
  • Agrees to no alcohol during the study
  • Agrees to maintain same level of physical activity throughout the study

Exclusion Criteria:

  • Smokers
  • Personal history of coronary heart disease, cerebrovascular disease or vascular disease, diabetes, bleeding disorder, liver or renal disease, or of cancer (other than skin cancer) in the last five years.
  • Use of drugs known to affect lipid metabolism, blood thinning agents, or hormones.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00535886
Other Study ID Numbers  ICMJE MM6222
IRB# 2005-45
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE UCSF Benioff Children’s Hospital Oakland
Collaborators  ICMJE National Cattlemen's Beef Association
Investigators  ICMJE
Principal Investigator: Ronald M Krauss, M.D. UCSF Benioff Children’s Hospital Oakland
Study Director: Patty Siri, Ph.D. UCSF Benioff Children’s Hospital Oakland
Study Director: Shira Miller, M.D. National Cattlemen's Beef Association
PRS Account UCSF Benioff Children’s Hospital Oakland
Verification Date September 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP