Cardiovascular DiseaseNCT00535886
The Effects of Natural Versus Man-Made Trans Fatty Acids on Lipoprotein Profiles: A Pilot Study
A study testing Man-made Trans FA, Natural Trans FA and Oleic Acid in people with Cardiovascular Disease and Diabetes, run by UCSF Benioff Children's Hospital Oakland at 1 site in United States.
Trial summary
The purpose of this study is to test the effects of natural vs. man-made trans fatty acids (trans fats) on blood cholesterol. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease, Diabetes, Dyslipidemia
- What is being tested?
- Man-made Trans FA, Natural Trans FA and Oleic Acid
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2005to Apr 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Oakland Research Institute
Oakland, California, 94609
About this study
The purpose of this study is to test the effects of natural vs. man-made trans fatty acids (trans fats) on blood cholesterol.
Read the 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:
- 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
- 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.
- Conditions
- Cardiovascular Disease, Diabetes, Dyslipidemia
- Being tested
- Man-made Trans FA, Natural Trans FA, Oleic Acid
- Keywords
- Trans Fatty Acids, conjugated linoleic acid, vaccenic acid, High Density Lipoprotein Cholesterol, Low Density Lipoprotein Cholesterol, Beef
- Medical subject headings
- Cardiovascular Diseases, Diabetes Mellitus, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Man-made Trans FADietary supplement
EA as 6% of total energy
Natural Trans FADietary supplement
VA as 6% of total energy
Oleic AcidDietary supplement
OA as 6% of total energy
| Study group | Role | What they receive |
|---|---|---|
| Elaidic Acid | Active comparator | Not described Receives: Dietary Supplement: Man-made Trans FA |
| Vaccenic Acid | Experimental | Not described Receives: Dietary Supplement: Natural Trans FA |
| Oleic Acid | Placebo comparator | Not described Receives: Dietary Supplement: Oleic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Five weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2007 (estimated)
- Study startNov 2005
- Study completionApr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCSF Benioff Children's Hospital Oakland
- Sponsor type
- University, hospital or other
- Collaborators
- National Cattlemen's Beef Association, a contractor to the Beef Checkoff
- Investigators
- Ronald M Krauss, M.D., Principal investigator, UCSF Benioff Children's Hospital OaklandPatty Siri, Ph.D., Study director, UCSF Benioff Children's Hospital OaklandShira Miller, M.D., Study director, National Cattlemen's Beef Association, a contractor to the Beef Checkoff
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00535886
- Sponsor's protocol ID
- MM6222
- Other IDs
- IRB# 2005-45
- Status last verified
- Sep 2007
- First submitted
- 21 Sep 2007
- Last updated
- 7 May 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 8094827Hu 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.
PubMed 9366580Ascherio 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.
PubMed 8688759Pietinen 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.
PubMed 9149659Oomen 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.
PubMed 11253967Mann GV. Metabolic consequences of dietary trans fatty acids. Lancet. 1994 May 21;343(8908):1268-71. doi: 10.1016/s0140-6736(94)92157-1.
PubMed 7910281Ip 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.
PubMed 14587866McLeod 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.
PubMed 15159253Rainer 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.
PubMed 15175596Turpeinen 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.
PubMed 12197992Steinhart 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.
PubMed 12915330Griinari 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.
PubMed 10958825
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Natural Versus Man-Made Trans Fatty Acids on Lipoprotein Profiles: A Pilot Study
- ClinicalTrials.gov ID
- NCT00535886
- Acronym / sponsor ID
- MM6222
- Conditions
- Cardiovascular Disease, Diabetes, Dyslipidemia
- Keywords
- Trans Fatty Acids, conjugated linoleic acid, vaccenic acid, High Density Lipoprotein Cholesterol, Low Density Lipoprotein Cholesterol, Beef
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- UCSF Benioff Children's Hospital OaklandUniversity, hospital or other
- Collaborators
- National Cattlemen's Beef Association, a contractor to the Beef Checkoff
- Study start
- Nov 2005
- Study completion
- Apr 2006 (actual)
- First posted
- 26 Sep 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
- 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Man-made Trans FAEA as 6% of total energy | Dietary supplement | Elaidic Acid |
| Natural Trans FAVA as 6% of total energy | Dietary supplement | Vaccenic Acid |
| Oleic AcidOA as 6% of total energy | Dietary supplement | Oleic Acid |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2008.
- Background: PubMed 8094827Willett 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.
- Background: PubMed 9366580Hu 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.
- Background: PubMed 8688759Ascherio 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.
- Background: PubMed 9149659Pietinen 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.
- Background: PubMed 11253967Oomen 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.
- Background: PubMed 7910281Mann GV. Metabolic consequences of dietary trans fatty acids. Lancet. 1994 May 21;343(8908):1268-71. doi: 10.1016/s0140-6736(94)92157-1.
- Background: PubMed 14587866Ip 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.
- Background: PubMed 15159253McLeod 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.
- Background: PubMed 15175596Rainer 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.
- Background: PubMed 12197992Turpeinen 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.
- Background: PubMed 12915330Steinhart 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.
- Background: PubMed 10958825Griinari 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ronald M Krauss, M.D. principal investigator
UCSF Benioff Children's Hospital Oakland
Patty Siri, Ph.D. study director
UCSF Benioff Children's Hospital Oakland
Shira Miller, M.D. study director
National Cattlemen's Beef Association, a contractor to the Beef Checkoff
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Man-made Trans FA, Natural Trans FA and Oleic Acid in people with Cardiovascular Disease and Diabetes, run by UCSF Benioff Children's Hospital Oakland at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00535886, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2008.