Cardiovascular DiseasesNCT02922062
The Effects of Consuming Palm Oil With Different Macronutrient Intakes on Blood Lipids
A study testing Canola Oil, Palm Oil and Butter in people with Cardiovascular Diseases and Inflammation, run by Ohio State University at 1 site in United States.
Trial summary
The purpose of this study is to determine the effects of palm oil when consumed as either part of a low carbohydrate diet or a high carbohydrate diet on blood lipids, cardiovascular health and inflammation. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases, Inflammation
- What is being tested?
- Canola Oil, Palm Oil and Butter
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2016to Mar 2018
- 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 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- normocholesterolemic
Who cannot join
- hypercholesterolemia
- diabetes
- liver disease
- kidney disease
- other metabolic or endocrine dysfunction
- diagnosis of cancer within the previous 5 years
Show all 9Show fewer
- hypertension
- current use of cholesterol reducing medications
- current use of diabetic medications
Trial locations and contacts
1 site in 1 country.
United States1 site
Physical Activity and Education Services (PAES) Building
Columbus, Ohio, 43210
About this study
Official title: The Effects of Palm Oil Consumed Under Different Macronutrient Distributions on Circulating Lipoprotein and Fatty Acid Profiles
The purpose of this study is to determine the effects of palm oil when consumed as either part of a low carbohydrate diet or a high carbohydrate diet on blood lipids, cardiovascular health and inflammation. The study will help us better understand how the quality of saturated fat and the quantity of carbohydrate interact to impact blood lipids and cardiovascular health.
Read the detailed description
The purpose of this study is to determine the effects of palm oil on blood lipids, cardiovascular health and inflammation. Potential subjects will be screened until 24 qualifying healthy participants are enrolled. After enrollment participants will undergo a baseline battery of tests including blood draws, body composition, measures of height and weight, blood lipid profile (cholesterol, lipoprotein particle size, quantity and fatty acid composition), insulin sensitivity using a static index, inflammation, antioxidant status and measurement of energy expenditure and substrate oxidation by indirect calorimetry. Participants will be randomly divided into one of two arms/tracks, either a low carbohydrate diet arm or a high carbohydrate diet arm. Each diet arm consists of 3 phases a low saturated fat control diet where the primary cooking oil is canola oil and two saturated fat diet phases where the primary cooking oil is either palm oil or butter.
Participants will begin with the low saturated fat diet phase first which consists of 50% of fat calories derived from canola oil for 3 weeks. At the end of this control diet phase the battery of tests completed at baseline will be repeated. After a 2-week washout period participants will then proceed in random order into either the palm oil or butter diet phases of their diet arm/track. The palm oil and butter diet phases are also 3 weeks in duration and separated by a 2 week washout period. The palm oil and butter diet phases will derive 50% of the fat calories from either palm oil or butter. Both oils are high in saturated fat but differ in the quality of saturated fat. At the end of each diet phase the testing battery completed at baseline will be repeated. The subjects will never be exposed to more than minimal risk and in return will receive 9 weeks of food, individualized reports of their study results and a monetary stipend. The study will help us better understand how the quality of saturated fat and the quantity of carbohydrate interact to impact blood lipids and cardiovascular health. This knowledge can be used to aid dietary recommendations for cardiovascular health and control of blood lipids.
- Conditions
- Cardiovascular Diseases, Inflammation
- Being tested
- Canola Oil, Palm Oil, Butter
- Keywords
- lipids, saturated fat, palm oil
- Medical subject headings
- Cardiovascular Diseases, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Canola OilOther
Also called low saturated fat control, Controlled Dietary Intervention using Canola Oil
Subjects will be provided with all their meals prepared in our metabolic kitchen in order to control their diets. The major cooking oil used in food preparation will be canola oil. The meals will be tailored to the caloric needs of each individual in order to maintain their body weight.
Palm OilOther
Also called saturated fat, Controlled Dietary Intervention using Palm Oil
Subjects will be provided with all their meals prepared in our metabolic kitchen in order to control their diets. The major cooking oil used in food preparation will be palm oil. The meals will be tailored to the caloric needs of each individual in order to maintain their body weight.
ButterOther
Also called saturated fat, Controlled Dietary Intervention using Butter
Subjects will be provided with all their meals prepared in our metabolic kitchen in order to control their diets. The major cooking oils used in food preparation will be butter. The meals will be tailored to the caloric needs of each individual in order to maintain their body weight.
| Study group | Role | What they receive |
|---|---|---|
| Low Carbohydrate Diet | Experimental | Half of the participants will be randomly assigned to this diet arm. The macronutrient composition of the diet will be (PRO (protein):CHO (carbohydrate):FAT, 18:8:74). There are three diet phases within this arm that use different fats as the primary cooking oil either canola oil, palm oil or butter. Each diet phase lasts for 3 weeks. At the end of each diet phase the testing battery completed at baseline will be repeated followed by a 2 week washout where subjects revert back to their usual diets. Canola oil is the low saturated fat control diet and is administered first. Participants then randomly begin either the palm oil or canola oil diet phases. Receives: Other: Canola Oil; Other: Palm Oil; Other: Butter |
| High Carbohydrate Diet | Active comparator | Half of the participants will be randomly assigned to this diet arm. The macronutrient composition of the diet will be (PRO:CHO:FAT, 18:60:22). There are three diet phases within this arm that use different fats as the primary cooking oil either canola oil, palm oil or butter. Each diet phase lasts for 3 weeks. At the end of each diet phase the testing battery completed at baseline will be repeated followed by a 2 week washout where subjects revert back to their usual diets. Canola oil is the low saturated fat control diet and is administered first. Participants then randomly begin either the palm oil or canola oil diet phases. Receives: Other: Canola Oil; Other: Palm Oil; Other: Butter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in High-Density Lipoprotein (HDL) Particle Size between Canola Oil and Palm Oil Diet Phases (Part of the Lipoprotein Distribution)
The change in HDL particle size and the number of each size particle between Canola Oil and Palm Oil diets will be assessed by Nuclear Magnetic Resonance (NMR) spectroscopy
Measured: Assessed during the 3rd week of the canola oil and palm oil diet
Change in HDL Particle Size between Canola Oil and Butter Diet Phases (Part of the Lipoprotein Distribution)
The change in HDL particle size and the number of each size particle between Canola Oil and Butter diets will be assessed by Nuclear Magnetic Resonance (NMR) spectroscopy
Measured: Assessed during the 3rd week of the canola oil and butter diets
Change in Low-Density Lipoprotein (LDL) Particle Size between Canola Oil and Palm Oil Diet Phases (Part of the Lipoprotein Distribution)
The change in LDL particle size and the number of each size particle between Canola Oil and Palm Oil diets will be assessed by NMR spectroscopy
Measured: Assessed during the 3rd week of the canola oil and palm oil diets
Change in LDL Particle Size between Canola Oil and Butter Diet Phases (Part of the Lipoprotein Distribution)
The change in LDL particle size and the number of each size particle between Canola Oil and Palm Oil diets will be assessed by NMR spectroscopy
Measured: Assessed during the 3rd week of the canola oil and butter diets
Change in Very Low-Density Lipoprotein (VLDL) Particle Size between Canola Oil and Palm Oil Diet Phases (Part of the Lipoprotein Distribution)
The change in VLDL particle size and the number of each size particle between Canola Oil and Palm Oil diets will be assessed by NMR spectroscopy
Measured: Assessed during the 3rd week of the canola oil and palm oil diets
Change in VLDL Particle Size between Canola Oil and Butter Diet Phases (Part of the Lipoprotein Distribution)
The change in VLDL particle size and the number of each size particle between Canola and Butter diets will be assessed by NMR spectroscopy
Measured: Assessed during the 3rd week of the canola oil and butter diets
Secondary outcomes (16)
Change in Insulin Sensitivity between the Canola Oil and Palm Oil Diet Phases
The change in glucose and insulin between Canola Oil and Palm Oil diets will be measured from plasma to determine the Homeostasis Model Assessment (HOMA) index score
Measured: Assessed during the 3rd week of the canola oil and palm oil diets
Change in Insulin Sensitivity between the Canola Oil and Butter Diet Phases
The change in glucose and insulin between Canola Oil and Palm Oil diets will be measured from plasma to determine the Homeostasis Model Assessment (HOMA) index score
Measured: Assessed during the 3rd week of the canola oil and butter diets
Change in Body Weight between the Canola Oil and Palm Oil Diet Phases
The change in body mass between Canola Oil and Palm Oil diets will be measured on a scale
Measured: Assessed during the 3rd week of the canola oil and palm oil diets
Change in Body Weight between the Canola Oil and Butter Diet Phases
The change in body mass between Canola Oil and Butter diets will be measured on a scale
Measured: Assessed during the 3rd week of the canola oil and butter diets
Change in Body Composition (Percent of Lean Mass, Fat Mass and Bone Mass according to the 3-compartment Model) between the Canola Oil and Palm Oil Diet Phases
The change in body composition between Canola Oil and Palm Oil diets will be measured by dual-energy X-ray absorptiometry
Measured: Assessed during the 3rd week of the canola oil and palm oil diets
Change in Body Composition (Percent of Lean Mass, Fat Mass and Bone Mass according to the 3-compartment Model) between the Canola Oil and Butter Diet Phases
The change in body composition between Canola Oil and Butter diets will be measured by dual-energy X-ray absorptiometry
Measured: Assessed during the 3rd week of the canola oil and butter diets
Change in the Cholesterol Profile between the Canola Oil and Palm Oil Diet Phases (Part of the Cholesterol Profile)
The change in total cholesterol and HDL cholesterol between Canola Oil and Palm Oil diets will be measured by immunoturbidimetry and LDL cholesterol will be calculated using these two values.
Measured: Assessed during the 3rd week of the canola oil and palm oil diets
Change in the Cholesterol Profile between the Canola Oil and Butter Diet Phases (Part of the Cholesterol Profile)
The change in total cholesterol and HDL cholesterol between Canola Oil and Butter diets will be measured by immunoturbidimetry and LDL cholesterol will be calculated using these two values.
Measured: Assessed during the 3rd week of the canola oil and butter diets
Change in Total Triglycerides between the Canola Oil and Palm Oil Diet Phases (Part of the Cholesterol Profile)
The change in triglycerides between Canola Oil and Palm Oil diets will be measured by immunoturbidimetry
Measured: Assessed during the 3rd week of the canola oil and palm oil diets
Change in Total Triglycerides between the Canola Oil and Butter Diet Phases (Part of the Cholesterol Profile)
The change in triglycerides between Canola Oil and Butter diets will be measured by immunoturbidimetry
Measured: Assessed during the 3rd week of the canola oil and butter diets
Change in the Apolopoprotein-A1 Concentration in plasma between the Canola Oil and Palm Oil Diet Phases (Part of the Cholesterol Profile)
The change in Apolopoprotein-A1 between Canola Oil and Palm Oil diets will be assessed by ELISA
Measured: Assessed during the 3rd week of the canola oil and palm oil diets
Change in the Apolopoprotein-A1 Concentration in plasma between the Canola Oil and Butter Diet Phases (Part of the Cholesterol Profile)
The change in Apolopoprotein-A1 between Canola Oil and Butter diets will be assessed by ELISA
Measured: Assessed during the 3rd week of the canola oil and butter diets
Change in the Apolopoprotein-B Concentration in plasma between the Canola Oil and Palm Oil Diet Phases (Part of the Cholesterol Profile)
The change in Apolopoprotein-B between Canola Oil and Palm Oil diets will be assessed by ELISA
Measured: Assessed during the 3rd week of the canola oil and Palm Oil diets
Change in the Apolopoprotein-B Concentration in plasma between the Canola Oil and Butter Diet Phases (Part of the Cholesterol Profile)
The change in Apolopoprotein-B between Canola Oil and Butter Diets will be assessed by ELISA
Measured: Assessed during the 3rd week of the canola oil and butter diets
Change in the Fatty Acid Composition of the Plasma between the Canola Oil and Palm Oil Diet Phases
Teh change in the fatty acid composition of the plasma between Canola Oil and Palm Oil diets will be assessed by gas chromatography using flame ionization detection
Measured: Assessed during the 3rd week of the canola oil and palm oil diets
Change in the Fatty Acid Composition of the Plasma between the Canola Oil and Butter Diet Phases
The change in the fatty acid composition of the plasma between Canola Oil and Butter will be assessed by gas chromatography using flame ionization detection
Measured: Assessed during the 3rd week of the canola oil and butter diets
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2016 (estimated)
- Study startNov 2016
- Primary completionMar 2018
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- Malaysia Palm Oil Board
- Responsible party
- Principal investigator, Jeff Volek, Ohio State University
- Investigators
- Jeff S Volek, Ph.D., Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02922062
- Sponsor's protocol ID
- GRT00038995
- Status last verified
- Aug 2018
- First submitted
- 17 Jun 2016
- Last updated
- 23 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: There is no plan to share data with other scientists but participants will be provided with their own individual data when the study is complete.
Publications
Clarke R, Frost C, Collins R, Appleby P, Peto R. Dietary lipids and blood cholesterol: quantitative meta-analysis of metabolic ward studies. BMJ. 1997 Jan 11;314(7074):112-7. doi: 10.1136/bmj.314.7074.112.
PubMed 9006469de Lorgeril M, Salen P, Martin JL, Monjaud I, Delaye J, Mamelle N. Mediterranean diet, traditional risk factors, and the rate of cardiovascular complications after myocardial infarction: final report of the Lyon Diet Heart Study. Circulation. 1999 Feb 16;99(6):779-85. doi: 10.1161/01.cir.99.6.779.
PubMed 9989963Howard BV, Van Horn L, Hsia J, Manson JE, Stefanick ML, Wassertheil-Smoller S, Kuller LH, LaCroix AZ, Langer RD, Lasser NL, Lewis CE, Limacher MC, Margolis KL, Mysiw WJ, Ockene JK, Parker LM, Perri MG, Phillips L, Prentice RL, Robbins J, Rossouw JE, Sarto GE, Schatz IJ, Snetselaar LG, Stevens VJ, Tinker LF, Trevisan M, Vitolins MZ, Anderson GL, Assaf AR, Bassford T, Beresford SA, Black HR, Brunner RL, Brzyski RG, Caan B, Chlebowski RT, Gass M, Granek I, Greenland P, Hays J, Heber D, Heiss G, Hendrix SL, Hubbell FA, Johnson KC, Kotchen JM. Low-fat dietary pattern and risk of cardiovascular disease: the Women's Health Initiative Randomized Controlled Dietary Modification Trial. JAMA. 2006 Feb 8;295(6):655-66. doi: 10.1001/jama.295.6.655.
PubMed 16467234Krauss RM. Lipoprotein subfractions and cardiovascular disease risk. Curr Opin Lipidol. 2010 Aug;21(4):305-11. doi: 10.1097/MOL.0b013e32833b7756.
PubMed 20531184Cromwell WC, Otvos JD, Keyes MJ, Pencina MJ, Sullivan L, Vasan RS, Wilson PW, D'Agostino RB. LDL Particle Number and Risk of Future Cardiovascular Disease in the Framingham Offspring Study - Implications for LDL Management. J Clin Lipidol. 2007 Dec;1(6):583-92. doi: 10.1016/j.jacl.2007.10.001.
PubMed 19657464Warensjo E, Riserus U, Vessby B. Fatty acid composition of serum lipids predicts the development of the metabolic syndrome in men. Diabetologia. 2005 Oct;48(10):1999-2005. doi: 10.1007/s00125-005-1897-x. Epub 2005 Aug 13.
PubMed 16132958Zong G, Zhu J, Sun L, Ye X, Lu L, Jin Q, Zheng H, Yu Z, Zhu Z, Li H, Sun Q, Lin X. Associations of erythrocyte fatty acids in the de novo lipogenesis pathway with risk of metabolic syndrome in a cohort study of middle-aged and older Chinese. Am J Clin Nutr. 2013 Aug;98(2):319-26. doi: 10.3945/ajcn.113.061218. Epub 2013 Jun 26.
PubMed 23803879Hodge AM, English DR, O'Dea K, Sinclair AJ, Makrides M, Gibson RA, Giles GG. Plasma phospholipid and dietary fatty acids as predictors of type 2 diabetes: interpreting the role of linoleic acid. Am J Clin Nutr. 2007 Jul;86(1):189-97. doi: 10.1093/ajcn/86.1.189.
PubMed 17616780Wang L, Folsom AR, Zheng ZJ, Pankow JS, Eckfeldt JH; ARIC Study Investigators. Plasma fatty acid composition and incidence of diabetes in middle-aged adults: the Atherosclerosis Risk in Communities (ARIC) Study. Am J Clin Nutr. 2003 Jul;78(1):91-8. doi: 10.1093/ajcn/78.1.91.
PubMed 12816776Kroger J, Zietemann V, Enzenbach C, Weikert C, Jansen EH, Doring F, Joost HG, Boeing H, Schulze MB. Erythrocyte membrane phospholipid fatty acids, desaturase activity, and dietary fatty acids in relation to risk of type 2 diabetes in the European Prospective Investigation into Cancer and Nutrition (EPIC)-Potsdam Study. Am J Clin Nutr. 2011 Jan;93(1):127-42. doi: 10.3945/ajcn.110.005447. Epub 2010 Oct 27.
PubMed 20980488Patel PS, Sharp SJ, Jansen E, Luben RN, Khaw KT, Wareham NJ, Forouhi NG. Fatty acids measured in plasma and erythrocyte-membrane phospholipids and derived by food-frequency questionnaire and the risk of new-onset type 2 diabetes: a pilot study in the European Prospective Investigation into Cancer and Nutrition (EPIC)-Norfolk cohort. Am J Clin Nutr. 2010 Nov;92(5):1214-22. doi: 10.3945/ajcn.2010.29182. Epub 2010 Sep 22.
PubMed 20861175Vessby B, Aro A, Skarfors E, Berglund L, Salminen I, Lithell H. The risk to develop NIDDM is related to the fatty acid composition of the serum cholesterol esters. Diabetes. 1994 Nov;43(11):1353-7. doi: 10.2337/diab.43.11.1353.
PubMed 7926311Mahendran Y, Agren J, Uusitupa M, Cederberg H, Vangipurapu J, Stancakova A, Schwab U, Kuusisto J, Laakso M. Association of erythrocyte membrane fatty acids with changes in glycemia and risk of type 2 diabetes. Am J Clin Nutr. 2014 Jan;99(1):79-85. doi: 10.3945/ajcn.113.069740. Epub 2013 Oct 23.
PubMed 24153340Miettinen TA, Naukkarinen V, Huttunen JK, Mattila S, Kumlin T. Fatty-acid composition of serum lipids predicts myocardial infarction. Br Med J (Clin Res Ed). 1982 Oct 9;285(6347):993-6. doi: 10.1136/bmj.285.6347.993.
PubMed 6812744Simon JA, Hodgkins ML, Browner WS, Neuhaus JM, Bernert JT Jr, Hulley SB. Serum fatty acids and the risk of coronary heart disease. Am J Epidemiol. 1995 Sep 1;142(5):469-76. doi: 10.1093/oxfordjournals.aje.a117662.
PubMed 7677125
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Palm Oil Consumed Under Different Macronutrient Distributions on Circulating Lipoprotein and Fatty Acid Profiles
- ClinicalTrials.gov ID
- NCT02922062
- Acronym / sponsor ID
- GRT00038995
- Conditions
- Cardiovascular Diseases, Inflammation
- Keywords
- lipids, saturated fat, palm oil
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- Malaysia Palm Oil Board
- Study start
- Nov 2016 (actual)
- Primary completion
- Mar 2018 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 3 Oct 2016 (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 determine the effects of palm oil when consumed as either part of a low carbohydrate diet or a high carbohydrate diet on blood lipids, cardiovascular health and inflammation. The study will help us better understand how the quality of saturated fat and the quantity of carbohydrate interact to impact blood lipids and cardiovascular health.
Detailed description
The purpose of this study is to determine the effects of palm oil on blood lipids, cardiovascular health and inflammation. Potential subjects will be screened until 24 qualifying healthy participants are enrolled. After enrollment participants will undergo a baseline battery of tests including blood draws, body composition, measures of height and weight, blood lipid profile (cholesterol, lipoprotein particle size, quantity and fatty acid composition), insulin sensitivity using a static index, inflammation, antioxidant status and measurement of energy expenditure and substrate oxidation by indirect calorimetry. Participants will be randomly divided into one of two arms/tracks, either a low carbohydrate diet arm or a high carbohydrate diet arm. Each diet arm consists of 3 phases a low saturated fat control diet where the primary cooking oil is canola oil and two saturated fat diet phases where the primary cooking oil is either palm oil or butter.
Participants will begin with the low saturated fat diet phase first which consists of 50% of fat calories derived from canola oil for 3 weeks. At the end of this control diet phase the battery of tests completed at baseline will be repeated. After a 2-week washout period participants will then proceed in random order into either the palm oil or butter diet phases of their diet arm/track. The palm oil and butter diet phases are also 3 weeks in duration and separated by a 2 week washout period. The palm oil and butter diet phases will derive 50% of the fat calories from either palm oil or butter. Both oils are high in saturated fat but differ in the quality of saturated fat. At the end of each diet phase the testing battery completed at baseline will be repeated. The subjects will never be exposed to more than minimal risk and in return will receive 9 weeks of food, individualized reports of their study results and a monetary stipend. The study will help us better understand how the quality of saturated fat and the quantity of carbohydrate interact to impact blood lipids and cardiovascular health. This knowledge can be used to aid dietary recommendations for cardiovascular health and control of blood lipids.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low Carbohydrate Diet | Experimental | Other: Canola Oil, Other: Palm Oil, Other: ButterHalf of the participants will be randomly assigned to this diet arm. The macronutrient composition of the diet will be (PRO (protein):CHO (carbohydrate):FAT, 18:8:74). There are three diet phases within this arm that use different fats as the primary cooking oil either canola oil, palm oil or butter. Each diet phase lasts for 3 weeks. At the end of each diet phase the testing battery completed at baseline will be repeated followed by a 2 week washout where subjects revert back to their usual diets. Canola oil is the low saturated fat control diet and is administered first. Participants then randomly begin either the palm oil or canola oil diet phases. |
| High Carbohydrate Diet | Active comparator | Other: Canola Oil, Other: Palm Oil, Other: ButterHalf of the participants will be randomly assigned to this diet arm. The macronutrient composition of the diet will be (PRO:CHO:FAT, 18:60:22). There are three diet phases within this arm that use different fats as the primary cooking oil either canola oil, palm oil or butter. Each diet phase lasts for 3 weeks. At the end of each diet phase the testing battery completed at baseline will be repeated followed by a 2 week washout where subjects revert back to their usual diets. Canola oil is the low saturated fat control diet and is administered first. Participants then randomly begin either the palm oil or canola oil diet phases. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- normocholesterolemic
Key exclusion criteria (9 listed)
- hypercholesterolemia
- diabetes
- liver disease
- kidney disease
- other metabolic or endocrine dysfunction
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 |
|---|---|---|
| Canola OilAlso: low saturated fat control, Controlled Dietary Intervention using Canola OilSubjects will be provided with all their meals prepared in our metabolic kitchen in order to control their diets. The major cooking oil used in food preparation will be canola oil. The meals will be tailored to the caloric needs of each individual in order to maintain their body weight. | Other | High Carbohydrate Diet, Low Carbohydrate Diet |
| Palm OilAlso: saturated fat, Controlled Dietary Intervention using Palm OilSubjects will be provided with all their meals prepared in our metabolic kitchen in order to control their diets. The major cooking oil used in food preparation will be palm oil. The meals will be tailored to the caloric needs of each individual in order to maintain their body weight. | Other | High Carbohydrate Diet, Low Carbohydrate Diet |
| ButterAlso: saturated fat, Controlled Dietary Intervention using ButterSubjects will be provided with all their meals prepared in our metabolic kitchen in order to control their diets. The major cooking oils used in food preparation will be butter. The meals will be tailored to the caloric needs of each individual in order to maintain their body weight. | Other | High Carbohydrate Diet, Low Carbohydrate Diet |
Primary outcome
Change in High-Density Lipoprotein (HDL) Particle Size between Canola Oil and Palm Oil Diet Phases (Part of the Lipoprotein Distribution)
Time frame: Assessed during the 3rd week of the canola oil and palm oil diet
The change in HDL particle size and the number of each size particle between Canola Oil and Palm Oil diets will be assessed by Nuclear Magnetic Resonance (NMR) spectroscopy
Change in HDL Particle Size between Canola Oil and Butter Diet Phases (Part of the Lipoprotein Distribution)
Time frame: Assessed during the 3rd week of the canola oil and butter diets
The change in HDL particle size and the number of each size particle between Canola Oil and Butter diets will be assessed by Nuclear Magnetic Resonance (NMR) spectroscopy
Change in Low-Density Lipoprotein (LDL) Particle Size between Canola Oil and Palm Oil Diet Phases (Part of the Lipoprotein Distribution)
Time frame: Assessed during the 3rd week of the canola oil and palm oil diets
The change in LDL particle size and the number of each size particle between Canola Oil and Palm Oil diets will be assessed by NMR spectroscopy
Change in LDL Particle Size between Canola Oil and Butter Diet Phases (Part of the Lipoprotein Distribution)
Time frame: Assessed during the 3rd week of the canola oil and butter diets
The change in LDL particle size and the number of each size particle between Canola Oil and Palm Oil diets will be assessed by NMR spectroscopy
Change in Very Low-Density Lipoprotein (VLDL) Particle Size between Canola Oil and Palm Oil Diet Phases (Part of the Lipoprotein Distribution)
Time frame: Assessed during the 3rd week of the canola oil and palm oil diets
The change in VLDL particle size and the number of each size particle between Canola Oil and Palm Oil diets will be assessed by NMR spectroscopy
Change in VLDL Particle Size between Canola Oil and Butter Diet Phases (Part of the Lipoprotein Distribution)
Time frame: Assessed during the 3rd week of the canola oil and butter diets
The change in VLDL particle size and the number of each size particle between Canola and Butter diets will be assessed by NMR spectroscopy
16 secondary outcomes
Change in Insulin Sensitivity between the Canola Oil and Palm Oil Diet Phases
Time frame: Assessed during the 3rd week of the canola oil and palm oil diets
Change in Insulin Sensitivity between the Canola Oil and Butter Diet Phases
Time frame: Assessed during the 3rd week of the canola oil and butter diets
Change in Body Weight between the Canola Oil and Palm Oil Diet Phases
Time frame: Assessed during the 3rd week of the canola oil and palm oil diets
Change in Body Weight between the Canola Oil and Butter Diet Phases
Time frame: Assessed during the 3rd week of the canola oil and butter diets
Change in Body Composition (Percent of Lean Mass, Fat Mass and Bone Mass according to the 3-compartment Model) between the Canola Oil and Palm Oil Diet Phases
Time frame: Assessed during the 3rd week of the canola oil and palm oil diets
Change in Body Composition (Percent of Lean Mass, Fat Mass and Bone Mass according to the 3-compartment Model) between the Canola Oil and Butter Diet Phases
Time frame: Assessed during the 3rd week of the canola oil and butter diets
Change in the Cholesterol Profile between the Canola Oil and Palm Oil Diet Phases (Part of the Cholesterol Profile)
Time frame: Assessed during the 3rd week of the canola oil and palm oil diets
Change in the Cholesterol Profile between the Canola Oil and Butter Diet Phases (Part of the Cholesterol Profile)
Time frame: Assessed during the 3rd week of the canola oil and butter diets
Change in Total Triglycerides between the Canola Oil and Palm Oil Diet Phases (Part of the Cholesterol Profile)
Time frame: Assessed during the 3rd week of the canola oil and palm oil diets
Change in Total Triglycerides between the Canola Oil and Butter Diet Phases (Part of the Cholesterol Profile)
Time frame: Assessed during the 3rd week of the canola oil and butter diets
Change in the Apolopoprotein-A1 Concentration in plasma between the Canola Oil and Palm Oil Diet Phases (Part of the Cholesterol Profile)
Time frame: Assessed during the 3rd week of the canola oil and palm oil diets
Change in the Apolopoprotein-A1 Concentration in plasma between the Canola Oil and Butter Diet Phases (Part of the Cholesterol Profile)
Time frame: Assessed during the 3rd week of the canola oil and butter diets
Change in the Apolopoprotein-B Concentration in plasma between the Canola Oil and Palm Oil Diet Phases (Part of the Cholesterol Profile)
Time frame: Assessed during the 3rd week of the canola oil and Palm Oil diets
Change in the Apolopoprotein-B Concentration in plasma between the Canola Oil and Butter Diet Phases (Part of the Cholesterol Profile)
Time frame: Assessed during the 3rd week of the canola oil and butter diets
Change in the Fatty Acid Composition of the Plasma between the Canola Oil and Palm Oil Diet Phases
Time frame: Assessed during the 3rd week of the canola oil and palm oil diets
Change in the Fatty Acid Composition of the Plasma between the Canola Oil and Butter Diet Phases
Time frame: Assessed during the 3rd week of the canola oil and butter diets
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 23 Aug 2018.
- Background: PubMed 9006469Clarke R, Frost C, Collins R, Appleby P, Peto R. Dietary lipids and blood cholesterol: quantitative meta-analysis of metabolic ward studies. BMJ. 1997 Jan 11;314(7074):112-7. doi: 10.1136/bmj.314.7074.112.
- Background: PubMed 9989963de Lorgeril M, Salen P, Martin JL, Monjaud I, Delaye J, Mamelle N. Mediterranean diet, traditional risk factors, and the rate of cardiovascular complications after myocardial infarction: final report of the Lyon Diet Heart Study. Circulation. 1999 Feb 16;99(6):779-85. doi: 10.1161/01.cir.99.6.779.
- Background: PubMed 16467234Howard BV, Van Horn L, Hsia J, Manson JE, Stefanick ML, Wassertheil-Smoller S, Kuller LH, LaCroix AZ, Langer RD, Lasser NL, Lewis CE, Limacher MC, Margolis KL, Mysiw WJ, Ockene JK, Parker LM, Perri MG, Phillips L, Prentice RL, Robbins J, Rossouw JE, Sarto GE, Schatz IJ, Snetselaar LG, Stevens VJ, Tinker LF, Trevisan M, Vitolins MZ, Anderson GL, Assaf AR, Bassford T, Beresford SA, Black HR, Brunner RL, Brzyski RG, Caan B, Chlebowski RT, Gass M, Granek I, Greenland P, Hays J, Heber D, Heiss G, Hendrix SL, Hubbell FA, Johnson KC, Kotchen JM. Low-fat dietary pattern and risk of cardiovascular disease: the Women's Health Initiative Randomized Controlled Dietary Modification Trial. JAMA. 2006 Feb 8;295(6):655-66. doi: 10.1001/jama.295.6.655.
- Background: PubMed 20531184Krauss RM. Lipoprotein subfractions and cardiovascular disease risk. Curr Opin Lipidol. 2010 Aug;21(4):305-11. doi: 10.1097/MOL.0b013e32833b7756.
- Background: PubMed 19657464Cromwell WC, Otvos JD, Keyes MJ, Pencina MJ, Sullivan L, Vasan RS, Wilson PW, D'Agostino RB. LDL Particle Number and Risk of Future Cardiovascular Disease in the Framingham Offspring Study - Implications for LDL Management. J Clin Lipidol. 2007 Dec;1(6):583-92. doi: 10.1016/j.jacl.2007.10.001.
- Background: PubMed 16132958Warensjo E, Riserus U, Vessby B. Fatty acid composition of serum lipids predicts the development of the metabolic syndrome in men. Diabetologia. 2005 Oct;48(10):1999-2005. doi: 10.1007/s00125-005-1897-x. Epub 2005 Aug 13.
- Background: PubMed 23803879Zong G, Zhu J, Sun L, Ye X, Lu L, Jin Q, Zheng H, Yu Z, Zhu Z, Li H, Sun Q, Lin X. Associations of erythrocyte fatty acids in the de novo lipogenesis pathway with risk of metabolic syndrome in a cohort study of middle-aged and older Chinese. Am J Clin Nutr. 2013 Aug;98(2):319-26. doi: 10.3945/ajcn.113.061218. Epub 2013 Jun 26.
- Background: PubMed 17616780Hodge AM, English DR, O'Dea K, Sinclair AJ, Makrides M, Gibson RA, Giles GG. Plasma phospholipid and dietary fatty acids as predictors of type 2 diabetes: interpreting the role of linoleic acid. Am J Clin Nutr. 2007 Jul;86(1):189-97. doi: 10.1093/ajcn/86.1.189.
- Background: PubMed 12816776Wang L, Folsom AR, Zheng ZJ, Pankow JS, Eckfeldt JH; ARIC Study Investigators. Plasma fatty acid composition and incidence of diabetes in middle-aged adults: the Atherosclerosis Risk in Communities (ARIC) Study. Am J Clin Nutr. 2003 Jul;78(1):91-8. doi: 10.1093/ajcn/78.1.91.
- Background: PubMed 20980488Kroger J, Zietemann V, Enzenbach C, Weikert C, Jansen EH, Doring F, Joost HG, Boeing H, Schulze MB. Erythrocyte membrane phospholipid fatty acids, desaturase activity, and dietary fatty acids in relation to risk of type 2 diabetes in the European Prospective Investigation into Cancer and Nutrition (EPIC)-Potsdam Study. Am J Clin Nutr. 2011 Jan;93(1):127-42. doi: 10.3945/ajcn.110.005447. Epub 2010 Oct 27.
- Background: PubMed 20861175Patel PS, Sharp SJ, Jansen E, Luben RN, Khaw KT, Wareham NJ, Forouhi NG. Fatty acids measured in plasma and erythrocyte-membrane phospholipids and derived by food-frequency questionnaire and the risk of new-onset type 2 diabetes: a pilot study in the European Prospective Investigation into Cancer and Nutrition (EPIC)-Norfolk cohort. Am J Clin Nutr. 2010 Nov;92(5):1214-22. doi: 10.3945/ajcn.2010.29182. Epub 2010 Sep 22.
- Background: PubMed 7926311Vessby B, Aro A, Skarfors E, Berglund L, Salminen I, Lithell H. The risk to develop NIDDM is related to the fatty acid composition of the serum cholesterol esters. Diabetes. 1994 Nov;43(11):1353-7. doi: 10.2337/diab.43.11.1353.
- Individual participant dataSharing planned: No. There is no plan to share data with other scientists but participants will be provided with their own individual data when the study is complete.
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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.
Jeff S Volek, Ph.D. principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Canola Oil, Palm Oil and Butter in people with Cardiovascular Diseases and Inflammation, run by Ohio State University 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 1 inclusion and 9 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 23 Aug 2018. 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. 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?
Change in High-Density Lipoprotein (HDL) Particle Size between Canola Oil and Palm Oil Diet Phases (Part of the Lipoprotein Distribution) (time frame: Assessed during the 3rd week of the canola oil and palm oil diet). The study lists 6 primary outcomes in all. 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 NCT02922062, which also lists 26 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 23 Aug 2018.