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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02922062
Other study ID # GRT00038995
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 2016
Est. completion date March 2018

Study information

Verified date August 2018
Source Ohio State University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date March 2018
Est. primary completion date March 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 21 Years to 65 Years
Eligibility Inclusion Criteria:

- normocholesterolemic

Exclusion Criteria:

- hypercholesterolemia

- diabetes

- liver disease

- kidney disease

- other metabolic or endocrine dysfunction

- diagnosis of cancer within the previous 5 years

- hypertension

- current use of cholesterol reducing medications

- current use of diabetic medications

Study Design


Related Conditions & MeSH terms


Intervention

Other:
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 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.
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.

Locations

Country Name City State
United States Physical Activity and Education Services (PAES) Building Columbus Ohio

Sponsors (2)

Lead Sponsor Collaborator
Ohio State University Malaysia Palm Oil Board

Country where clinical trial is conducted

United States, 

References & Publications (26)

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Forsythe CE, Phinney SD, Feinman RD, Volk BM, Freidenreich D, Quann E, Ballard K, Puglisi MJ, Maresh CM, Kraemer WJ, Bibus DM, Fernandez ML, Volek JS. Limited effect of dietary saturated fat on plasma saturated fat in the context of a low carbohydrate diet. Lipids. 2010 Oct;45(10):947-62. doi: 10.1007/s11745-010-3467-3. Epub 2010 Sep 7. — View Citation

Forsythe CE, Phinney SD, Fernandez ML, Quann EE, Wood RJ, Bibus DM, Kraemer WJ, Feinman RD, Volek JS. Comparison of low fat and low carbohydrate diets on circulating fatty acid composition and markers of inflammation. Lipids. 2008 Jan;43(1):65-77. Epub 2007 Nov 29. — View Citation

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Hodge 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. — View Citation

Howard 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. — View Citation

Krauss RM. Lipoprotein subfractions and cardiovascular disease risk. Curr Opin Lipidol. 2010 Aug;21(4):305-11. doi: 10.1097/MOL.0b013e32833b7756. Review. — View Citation

Kröger J, Zietemann V, Enzenbach C, Weikert C, Jansen EH, Döring 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. — View Citation

Mahendran Y, Ågren J, Uusitupa M, Cederberg H, Vangipurapu J, Stancáková 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. — View Citation

Matthews DR, Hosker JP, Rudenski AS, Naylor BA, Treacher DF, Turner RC. Homeostasis model assessment: insulin resistance and beta-cell function from fasting plasma glucose and insulin concentrations in man. Diabetologia. 1985 Jul;28(7):412-9. — View Citation

Miettinen 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. — View Citation

Otvos JD, Jeyarajah EJ, Bennett DW, Krauss RM. Development of a proton nuclear magnetic resonance spectroscopic method for determining plasma lipoprotein concentrations and subspecies distributions from a single, rapid measurement. Clin Chem. 1992 Sep;38(9):1632-8. — View Citation

Patel 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. Erratum in: Am J Clin Nutr. 2013 Jul;98(1):255-8. — View Citation

Simon 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. — View Citation

Vessby 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. — View Citation

Volek JS, Phinney SD, Forsythe CE, Quann EE, Wood RJ, Puglisi MJ, Kraemer WJ, Bibus DM, Fernandez ML, Feinman RD. Carbohydrate restriction has a more favorable impact on the metabolic syndrome than a low fat diet. Lipids. 2009 Apr;44(4):297-309. doi: 10.1007/s11745-008-3274-2. Epub 2008 Dec 12. — View Citation

Volk BM, Kunces LJ, Freidenreich DJ, Kupchak BR, Saenz C, Artistizabal JC, Fernandez ML, Bruno RS, Maresh CM, Kraemer WJ, Phinney SD, Volek JS. Effects of step-wise increases in dietary carbohydrate on circulating saturated Fatty acids and palmitoleic Acid in adults with metabolic syndrome. PLoS One. 2014 Nov 21;9(11):e113605. doi: 10.1371/journal.pone.0113605. eCollection 2014. — View Citation

Wang L, Folsom AR, Eckfeldt JH. Plasma fatty acid composition and incidence of coronary heart disease in middle aged adults: the Atherosclerosis Risk in Communities (ARIC) Study. Nutr Metab Cardiovasc Dis. 2003 Oct;13(5):256-66. — View Citation

Wang 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. — View Citation

Warensjö E, Risérus 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. Epub 2005 Aug 13. — View Citation

Yamagishi K, Nettleton JA, Folsom AR; ARIC Study Investigators. Plasma fatty acid composition and incident heart failure in middle-aged adults: the Atherosclerosis Risk in Communities (ARIC) Study. Am Heart J. 2008 Nov;156(5):965-74. doi: 10.1016/j.ahj.2008.06.017. Epub 2008 Aug 29. — View Citation

Zong 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. — View Citation

* Note: There are 26 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Other Change in C-Reactive Protein between the Canola Oil and Palm Oil Diet Phases (Part of an Inflammatory Panel) The change in C-Reactive Protein between Canola Oil and Palm Oil diets will be assessed using a multiplex ELISA platform Assessed during the 3rd week of the canola oil and palm oil diets
Other Change in C-Reactive Protein between the Canola Oil and Butter Diet Phases (Part of an Inflammatory Panel) The change in C-Reactive Protein between Canola Oil and Palm Oil diets will be assessed using a multiplex ELISA platform Assessed during the 3rd week of the canola oil and butter diets
Other Change in Interleukin (IL)-1beta Protein between the Canola Oil and Palm Oil Diet Phases (Part of an Inflammatory Panel) The change in IL-1beta between Canola Oil and Palm Oil diets will be assessed using a multiplex ELISA platform Assessed during the 3rd week of the canola oil and palm oil diets
Other Change in IL-1beta Protein between the Canola Oil and Butter Diet Phases (Part of an Inflammatory Panel) The change in IL-1beta between Canola Oil and Butter diets will be assessed using a multiplex ELISA platform Assessed during the 3rd week of the canola oil and butter diets
Other Change in Tumor Necrosis Factor (TNF)-alpha between the Canola Oil and Palm Oil Diet Phases (Part of an Inflammatory Panel) The change in TNF-alpha between Canola Oil and Palm Oil diets will be assessed using a multiplex ELISA platform Assessed during the 3rd week of the canola oil and palm oil diets
Other Change in TNF-alpha between the Canola Oil and Butter Diet Phases (Part of an Inflammatory Panel) The change in TNF-alpha between Canola Oil and Palm Oil will be assessed using a multiplex ELISA platform Assessed during the 3rd week of the canola oil and butter diets
Other Change in Neopterin between the Canola Oil and Palm Oil Diet Phases (Part of an Inflammatory Panel) The change in TNF-alpha between Canola Oil and Palm Oil diets will be assessed using a singleplex ELISA platform Assessed during the 3rd week of the canola oil and palm oil diets
Other Change in Neopterin between the Canola Oil and Butter Diet Phases (Part of an Inflammatory Panel) The change in Neopterin between Canola Oil and Butter diets will be assessed using a singleplex ELISA platform Assessed during the 3rd week of the canola oil and butter diets
Other Change in Elastase between the Canola Oil and Palm Oil Diet Phases (Part of an Inflammatory Panel) The change in Elastase between Canola Oil and Palm Oil diets will be assessed using a singleplex ELISA platform Assessed during the 3rd week of the canola oil and palm oil diets
Other Change in Elastase between the Canola Oil and Butter Diet Phases (Part of an Inflammatory Panel) The change in Elastase between Canola Oil and Butter diets will be assessed using a singleplex ELISA platform Assessed during the 3rd week of the canola oil and butter diets
Other Change in Conjugated Dienes between the Canola Oil and Palm Oil Diet Phases (Part of an Antioxidant Status Assessment) The change in Conjugated dienes, an early stage lipid peroxidation product, between Canola Oil and Palm Oil diets will be assessed by spectrophotometry. Assessed during the 3rd week of the canola oil and palm oil diets
Other Change in Conjugated Dienes between the Canola Oil and Butter Diet Phases (Part of an Antioxidant Status Assessment) The change in Conjugated dienes, an early stage lipid peroxidation product, between Canola Oil and Butter diets will be assessed by spectrophotometry. Assessed during the 3rd week of the canola oil and butter diets
Other Change in Malondialdehyde between the Canola Oil and Palm Oil Diet Phases (Part of an Antioxidant Status Assessment) The change in Malondialdehyde, a late stage lipid peroxidation product, between Canola Oil and Palm Oil diets will be assessed by spectroscopy. Assessed during the 3rd week of the canola oil and palm oil diets
Other Change in Malondialdehyde between the Canola Oil and Butter Diet Phases (Part of an Antioxidant Status Assessment) The change in Malondialdehyde, a late stage lipid peroxidation product, between Canola Oil and Butter diets will be assessed by high performance liquid chromatography. Assessed during the 3rd week of the canola oil and butter diets
Other Change in the Total Antioxidant Capacity of the blood between the Canola Oil and Palm Oil Diet Phases (Part of an Antioxidant Status Assessment) The change in the total antioxidant capacity of the blood between Canola Oil and Palm Oil diets will be assessed by spectrophotometry using the Ferric Reducing Antioxidant Power (FRAP) assay. Assessed during the 3rd week of the canola oil and palm oil diets
Other Change in the Total Antioxidant Capacity of the blood between the Canola Oil and Butter Diet Phases (Part of an Antioxidant Status Assessment) The change in the total antioxidant capacity of the blood between Canola Oil and Butter diets will be assessed by spectrophotometry using the FRAP assay. Assessed during the 3rd week of the canola oil and butter diets
Primary 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 Assessed during the 3rd week of the canola oil and palm oil diet
Primary 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 Assessed during the 3rd week of the canola oil and butter diets
Primary 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 Assessed during the 3rd week of the canola oil and palm oil diets
Primary 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 Assessed during the 3rd week of the canola oil and butter diets
Primary 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 Assessed during the 3rd week of the canola oil and palm oil diets
Primary 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 Assessed during the 3rd week of the canola oil and butter diets
Secondary 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 Assessed during the 3rd week of the canola oil and palm oil diets
Secondary 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 Assessed during the 3rd week of the canola oil and butter diets
Secondary 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 Assessed during the 3rd week of the canola oil and palm oil diets
Secondary 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 Assessed during the 3rd week of the canola oil and butter diets
Secondary 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 Assessed during the 3rd week of the canola oil and palm oil diets
Secondary 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 Assessed during the 3rd week of the canola oil and butter diets
Secondary 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. Assessed during the 3rd week of the canola oil and palm oil diets
Secondary 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. Assessed during the 3rd week of the canola oil and butter diets
Secondary 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 Assessed during the 3rd week of the canola oil and palm oil diets
Secondary 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 Assessed during the 3rd week of the canola oil and butter diets
Secondary 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 Assessed during the 3rd week of the canola oil and palm oil diets
Secondary 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 Assessed during the 3rd week of the canola oil and butter diets
Secondary 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 Assessed during the 3rd week of the canola oil and Palm Oil diets
Secondary 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 Assessed during the 3rd week of the canola oil and butter diets
Secondary 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 Assessed during the 3rd week of the canola oil and palm oil diets
Secondary 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 Assessed during the 3rd week of the canola oil and butter diets
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