NCT00535886

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2005

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2005

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2006

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

September 21, 2007

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 26, 2007

Completed
Last Updated

May 7, 2008

Status Verified

September 1, 2007

First QC Date

September 21, 2007

Last Update Submit

May 5, 2008

Conditions

Cardiovascular DiseaseDiabetesDyslipidemia

Keywords

Trans Fatty Acidsconjugated linoleic acidvaccenic acidHigh Density Lipoprotein CholesterolLow Density Lipoprotein CholesterolBeef

Outcome Measures

Primary Outcomes (1)

  • 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.

    Five weeks

Secondary Outcomes (1)

  • 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.

    Five weeks

Study Arms (3)

Elaidic Acid

ACTIVE COMPARATOR
Dietary Supplement: Man-made Trans FA

Vaccenic Acid

EXPERIMENTAL
Dietary Supplement: Natural Trans FA

Oleic Acid

PLACEBO COMPARATOR
Dietary Supplement: Oleic Acid

Interventions

Man-made Trans FADIETARY_SUPPLEMENT

EA as 6% of total energy

Elaidic Acid
Natural Trans FADIETARY_SUPPLEMENT

VA as 6% of total energy

Vaccenic Acid
Oleic AcidDIETARY_SUPPLEMENT

OA as 6% of total energy

Oleic Acid

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital Oakland Research Institute

Oakland, California, 94609, United States

Location

Related Publications (12)

  • Willett WC, Stampfer MJ, Manson JE, Colditz GA, Speizer FE, Rosner BA, Sampson LA, Hennekens CH. Intake of trans fatty acids and risk of coronary heart disease among women. Lancet. 1993 Mar 6;341(8845):581-5. doi: 10.1016/0140-6736(93)90350-p.

    PMID: 8094827BACKGROUND

  • Hu FB, Stampfer MJ, Manson JE, Rimm E, Colditz GA, Rosner BA, Hennekens CH, Willett WC. Dietary fat intake and the risk of coronary heart disease in women. N Engl J Med. 1997 Nov 20;337(21):1491-9. doi: 10.1056/NEJM199711203372102.

    PMID: 9366580BACKGROUND

  • Ascherio A, Rimm EB, Giovannucci EL, Spiegelman D, Stampfer M, Willett WC. Dietary fat and risk of coronary heart disease in men: cohort follow up study in the United States. BMJ. 1996 Jul 13;313(7049):84-90. doi: 10.1136/bmj.313.7049.84.

    PMID: 8688759BACKGROUND

  • Pietinen P, Ascherio A, Korhonen P, Hartman AM, Willett WC, Albanes D, Virtamo J. Intake of fatty acids and risk of coronary heart disease in a cohort of Finnish men. The Alpha-Tocopherol, Beta-Carotene Cancer Prevention Study. Am J Epidemiol. 1997 May 15;145(10):876-87. doi: 10.1093/oxfordjournals.aje.a009047.

    PMID: 9149659BACKGROUND

  • Oomen CM, Ocke MC, Feskens EJ, van Erp-Baart MA, Kok FJ, Kromhout D. Association between trans fatty acid intake and 10-year risk of coronary heart disease in the Zutphen Elderly Study: a prospective population-based study. Lancet. 2001 Mar 10;357(9258):746-51. doi: 10.1016/s0140-6736(00)04166-0.

    PMID: 11253967BACKGROUND

  • Mann GV. Metabolic consequences of dietary trans fatty acids. Lancet. 1994 May 21;343(8908):1268-71. doi: 10.1016/s0140-6736(94)92157-1.

    PMID: 7910281BACKGROUND

  • Ip MM, Masso-Welch PA, Ip C. Prevention of mammary cancer with conjugated linoleic acid: role of the stroma and the epithelium. J Mammary Gland Biol Neoplasia. 2003 Jan;8(1):103-18. doi: 10.1023/a:1025739506536.

    PMID: 14587866BACKGROUND

  • McLeod RS, LeBlanc AM, Langille MA, Mitchell PL, Currie DL. Conjugated linoleic acids, atherosclerosis, and hepatic very-low-density lipoprotein metabolism. Am J Clin Nutr. 2004 Jun;79(6 Suppl):1169S-1174S. doi: 10.1093/ajcn/79.6.1169S.

    PMID: 15159253BACKGROUND

  • Rainer L, Heiss CJ. Conjugated linoleic acid: health implications and effects on body composition. J Am Diet Assoc. 2004 Jun;104(6):963-8, quiz 1032. doi: 10.1016/j.jada.2004.03.016.

    PMID: 15175596BACKGROUND

  • Turpeinen AM, Mutanen M, Aro A, Salminen I, Basu S, Palmquist DL, Griinari JM. Bioconversion of vaccenic acid to conjugated linoleic acid in humans. Am J Clin Nutr. 2002 Sep;76(3):504-10. doi: 10.1093/ajcn/76.3.504.

    PMID: 12197992BACKGROUND

  • Steinhart H, Rickert R, Winkler K. Trans fatty acids (TFA): analysis, occurrence, intake and clinical relevance. Eur J Med Res. 2003 Aug 20;8(8):358-62.

    PMID: 12915330BACKGROUND

  • Griinari JM, Corl BA, Lacy SH, Chouinard PY, Nurmela KV, Bauman DE. Conjugated linoleic acid is synthesized endogenously in lactating dairy cows by Delta(9)-desaturase. J Nutr. 2000 Sep;130(9):2285-91. doi: 10.1093/jn/130.9.2285.

    PMID: 10958825BACKGROUND

MeSH Terms

Conditions

Cardiovascular DiseasesDiabetes MellitusDyslipidemias

Interventions

Oleic Acid

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesLipid Metabolism Disorders

Intervention Hierarchy (Ancestors)

Oleic AcidsFatty Acids, MonounsaturatedFatty Acids, UnsaturatedFatty AcidsLipids

Study Officials

  • Ronald M Krauss, M.D.

    UCSF Benioff Children's Hospital Oakland

    PRINCIPAL INVESTIGATOR

  • Patty Siri, Ph.D.

    UCSF Benioff Children's Hospital Oakland

    STUDY DIRECTOR

  • Shira Miller, M.D.

    National Cattlemen's Beef Association, a contractor to the Beef Checkoff

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 21, 2007

First Posted

September 26, 2007

Study Start

November 1, 2005

Study Completion

April 1, 2006

Last Updated

May 7, 2008

Record last verified: 2007-09

Locations

US(1)