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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05539742
Other study ID # 2022/6
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 1, 2022
Est. completion date November 1, 2022

Study information

Verified date August 2023
Source University of Jordan
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The main objective is to investigate if foods high in coconut oil (MCFA) or palm oil (LCFA) have different impacts on postprandial blood lipid levels and appetite via a visual analog scale (VAS).


Description:

Postprandial lipemia has been recognized as a cardiovascular disease risk factor. The rate of postprandial triglyceride production and clearance in the blood, as well as the appetite, are influenced by the quality of the food consumed, such as the length of saturated fatty acids. The study will include 24 healthy adults ranging in age from 18 to 40 years old, of both sexes and it will be conducted at the University of Jordan. The study will involve two experimental test days, each separated by at least a week of washout interval, and each test day will last for 6 hours. All subjects will be randomly assigned to one of the experimental meals using computer-generated tables. Blood serum samples (2 mL) will be taken after an overnight fast and 2, 4, and 6 hours after eating the meals, and blood lipid profiles [total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), and triglyceride (TG)] will be examined in a private lab. After that, participants will be allowed an ad libitum intake of standard meals. Each meal will be weighed before and after it is consumed, with the amount of food ingested being calculated.


Recruitment information / eligibility

Status Completed
Enrollment 26
Est. completion date November 1, 2022
Est. primary completion date October 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria: - Age between 18-50 years - Males and females - Apparently healthy - Fasting triglyceride (TG) < 2.5 mmol/L or 222 mg/dl at the time of screening. - Body mass index (BMI) in normal range (18.5-24.9). - Stable weight for at least 3 months Exclusion Criteria: - Consumption of lipid-lowering drugs or any medication that might affect appetite. - Consumption of any supplement that may affect lipid metabolism or appetite on a regular basis for the past month. - Regular consumption of two or more fish meals a week over the previous month. - A history of diabetes, gastrointestinal , liver disease, congestive heart failure, stroke, myocardial infarction, coronary artery bypass graft or established atherosclerotic disease. - Current smokers - Pregnant , breastfeeding, postmenopausal or suffer from polycystic ovary syndrome (PCOS) - Athlete - Being on a diet or lifestyle changes for the past month.

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Coconut oil
Coconut oil will be given to each participant in the amount of 40 g, which will be incorporated into biscuits.
Palm oil
Palm oil will be given to each participant in the amount of 40 g, which will be incorporated into biscuits.

Locations

Country Name City State
Jordan The University of Jordan Amman
Jordan The University of Jordan Amman

Sponsors (1)

Lead Sponsor Collaborator
University of Jordan

Country where clinical trial is conducted

Jordan, 

References & Publications (22)

Abedi E, Sahari MA. Long-chain polyunsaturated fatty acid sources and evaluation of their nutritional and functional properties. Food Sci Nutr. 2014 Sep;2(5):443-63. doi: 10.1002/fsn3.121. Epub 2014 Jun 29. — View Citation

Austin G, Ferguson JJ, Thota RN, Singh H, Burrows T, Garg ML. Postprandial lipaemia following consumption of a meal enriched with medium chain saturated and/or long chain omega-3 polyunsaturated fatty acids. A randomised cross-over study. Clin Nutr. 2021 Feb;40(2):420-427. doi: 10.1016/j.clnu.2020.06.027. Epub 2020 Jul 1. — View Citation

Behrouz V, Yari Z. A review on differential effects of dietary fatty acids on weight, appetite and energy expenditure. Crit Rev Food Sci Nutr. 2022;62(8):2235-2249. doi: 10.1080/10408398.2020.1852172. Epub 2020 Dec 1. — View Citation

Boateng L, Ansong R, Owusu WB, Steiner-Asiedu M. Coconut oil and palm oil's role in nutrition, health and national development: A review. Ghana Med J. 2016 Sep;50(3):189-196. — View Citation

Bozzetto L, Della Pepa G, Vetrani C, Rivellese AA. Dietary Impact on Postprandial Lipemia. Front Endocrinol (Lausanne). 2020 Jul 7;11:337. doi: 10.3389/fendo.2020.00337. eCollection 2020. — View Citation

Dias CB, Moughan PJ, Wood LG, Singh H, Garg ML. Postprandial lipemia: factoring in lipemic response for ranking foods for their healthiness. Lipids Health Dis. 2017 Sep 18;16(1):178. doi: 10.1186/s12944-017-0568-5. — View Citation

Folwaczny A, Waldmann E, Altenhofer J, Henze K, Parhofer KG. Postprandial Lipid Metabolism in Normolipidemic Subjects and Patients with Mild to Moderate Hypertriglyceridemia: Effects of Test Meals Containing Saturated Fatty Acids, Mono-Unsaturated Fatty Acids, or Medium-Chain Fatty Acids. Nutrients. 2021 May 20;13(5):1737. doi: 10.3390/nu13051737. — View Citation

Karupaiah T, Tan CH, Chinna K, Sundram K. The chain length of dietary saturated fatty acids affects human postprandial lipemia. J Am Coll Nutr. 2011 Dec;30(6):511-21. doi: 10.1080/07315724.2011.10719997. — View Citation

Kaviani S, Cooper JA. Appetite responses to high-fat meals or diets of varying fatty acid composition: a comprehensive review. Eur J Clin Nutr. 2017 Oct;71(10):1154-1165. doi: 10.1038/ejcn.2016.250. Epub 2017 Jan 18. — View Citation

Khaw KT, Sharp SJ, Finikarides L, Afzal I, Lentjes M, Luben R, Forouhi NG. Randomised trial of coconut oil, olive oil or butter on blood lipids and other cardiovascular risk factors in healthy men and women. BMJ Open. 2018 Mar 6;8(3):e020167. doi: 10.1136/bmjopen-2017-020167. — View Citation

Ma WY, Yang CY, Shih SR, Hsieh HJ, Hung CS, Chiu FC, Lin MS, Liu PH, Hua CH, Hsein YC, Chuang LM, Lin JW, Wei JN, Li HY. Measurement of Waist Circumference: midabdominal or iliac crest? Diabetes Care. 2013 Jun;36(6):1660-6. doi: 10.2337/dc12-1452. Epub 2012 Dec 28. — View Citation

Maher T, Sampson A, Goslawska M, Pangua-Irigaray C, Shafat A, Clegg ME. Food Intake and Satiety Response after Medium-Chain Triglycerides Ingested as Solid or Liquid. Nutrients. 2019 Jul 17;11(7):1638. doi: 10.3390/nu11071638. — View Citation

Moneeb AHM, Hammam ARA, Ahmed AKA, Ahmed ME, Alsaleem KA. Effect of fat extraction methods on the fatty acids composition of bovine milk using gas chromatography. Food Sci Nutr. 2021 May 4;9(6):2936-2942. doi: 10.1002/fsn3.2252. eCollection 2021 Jun. — View Citation

Montoya C, Cochard B, Flori A, Cros D, Lopes R, Cuellar T, Espeout S, Syaputra I, Villeneuve P, Pina M, Ritter E, Leroy T, Billotte N. Genetic architecture of palm oil fatty acid composition in cultivated oil palm (Elaeis guineensis Jacq.) compared to its wild relative E. oleifera (H.B.K) Cortes. PLoS One. 2014 May 9;9(5):e95412. doi: 10.1371/journal.pone.0095412. eCollection 2014. Erratum In: PLoS One. 2014;9(6):e101628. — View Citation

Panth N, Abbott KA, Dias CB, Wynne K, Garg ML. Differential effects of medium- and long-chain saturated fatty acids on blood lipid profile: a systematic review and meta-analysis. Am J Clin Nutr. 2018 Oct 1;108(4):675-687. doi: 10.1093/ajcn/nqy167. Erratum In: Am J Clin Nutr. 2018 Dec 1;108(6):1356. — View Citation

Panth N, Dias CB, Wynne K, Singh H, Garg ML. Medium-chain fatty acids lower postprandial lipemia: A randomized crossover trial. Clin Nutr. 2020 Jan;39(1):90-96. doi: 10.1016/j.clnu.2019.02.008. Epub 2019 Feb 16. — View Citation

Pirillo A, Norata GD, Catapano AL. Postprandial lipemia as a cardiometabolic risk factor. Curr Med Res Opin. 2014 Aug;30(8):1489-503. doi: 10.1185/03007995.2014.909394. Epub 2014 May 2. — View Citation

Schonfeld P, Wojtczak L. Short- and medium-chain fatty acids in energy metabolism: the cellular perspective. J Lipid Res. 2016 Jun;57(6):943-54. doi: 10.1194/jlr.R067629. Epub 2016 Apr 14. — View Citation

Tan J, McKenzie C, Potamitis M, Thorburn AN, Mackay CR, Macia L. The role of short-chain fatty acids in health and disease. Adv Immunol. 2014;121:91-119. doi: 10.1016/B978-0-12-800100-4.00003-9. — View Citation

Teng KT, Chang CY, Kanthimathi MS, Tan AT, Nesaretnam K. Effects of amount and type of dietary fats on postprandial lipemia and thrombogenic markers in individuals with metabolic syndrome. Atherosclerosis. 2015 Sep;242(1):281-7. doi: 10.1016/j.atherosclerosis.2015.07.003. Epub 2015 Jul 7. — View Citation

Tvrzicka E, Kremmyda LS, Stankova B, Zak A. Fatty acids as biocompounds: their role in human metabolism, health and disease--a review. Part 1: classification, dietary sources and biological functions. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2011 Jun;155(2):117-30. doi: 10.5507/bp.2011.038. — View Citation

Zentek J, Buchheit-Renko S, Ferrara F, Vahjen W, Van Kessel AG, Pieper R. Nutritional and physiological role of medium-chain triglycerides and medium-chain fatty acids in piglets. Anim Health Res Rev. 2011 Jun;12(1):83-93. doi: 10.1017/S1466252311000089. — View Citation

* Note: There are 22 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Anthropometric measurements ( Height) Standing height, without footwear, will be taken using stadiometer to the nearest 5mm baseline, pre-intervention, 1 day for each participant /during 3 months
Primary Anthropometric measurements (Weight) Bioelectrical impedance will be used to determine body weight baseline, pre-intervention, 1 day for each participant /during 3 months
Primary Anthropometric measurements (waist circumference) Waist circumference (WC) will be measured at the midway between the lowest ribs and the iliac crest using a standard tape to the nearest 1 cm baseline, pre-intervention, 1 day for each participant /during 3 months
Primary Anthropometric measurements (percentage body fat) Bioelectrical impedance will be used to determine body composition baseline, pre-intervention,1 day for each participant /during 3 months
Primary Biochemical measurements (Total cholesterol (TC)) Up to 6 hours After the intervention / up to 3 months from collecting the samples
Primary Biochemical measurements (Low density lipoprotein cholesterol (LDL)) Low-density lipoprotein cholesterol test will be performed after an overnight fast and 2, 4, and 6 hours after eating the meals Up to 6 hours
Primary Biochemical measurements ( High density lipoprotein cholesterol (HDL)) High-density lipoprotein cholesterol test will be performed after an overnight fast and 2, 4, and 6 hours after eating the meals Up to 6 hours
Primary Biochemical measurements (Triglyceride (TG)) Triglyceride test will be performed after an overnight fast and 2, 4, and 6 hours after eating the meals Up to 6 hours
Primary Dietary intake (3-days food record) Participants will be asked to fill out a food record to track changes in their (intake) appetite one day
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