- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05539742
Comparison of the Effect of MCFA and LCFA on Postprandial Appetite and Lipemia
August 27, 2023 updated by: Shatha Hammad, Assistant Professor, University of Jordan
Comparison of the Effect of Medium-Chain Fatty Acids and Long-Chain Fatty Acids on Postprandial Appetite and Lipemia
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment (Actual)
26
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Amman, Jordan, 11942
- The university of Jordan
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Amman, Jordan
- The university of Jordan
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (Adult)
Accepts Healthy Volunteers
Yes
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Coconut oil
The coconut oil will be given to each participant in the amount of 40 g, which will be incorporated into biscuits.
Each participant will have ten minutes to consume biscuits with 250 ml of water.
No other food will be consumed during the study period (6 hours).
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.
Then the participants will take the other treatment after a 1-week washout interval.
|
Coconut oil will be given to each participant in the amount of 40 g, which will be incorporated into biscuits.
|
Active Comparator: Palm oil
The palm oil will be given to each participant in the amount of 40 g, which will be incorporated into biscuits.
Each participant will have ten minutes to consume biscuits with 250 ml of water.
No other food will be consumed during the study period (6 hours).
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.
Then the participants will take the other treatment after a 1-week washout interval.
|
Palm oil will be given to each participant in the amount of 40 g, which will be incorporated into biscuits.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Anthropometric measurements ( Height)
Time Frame: baseline, pre-intervention, 1 day for each participant /during 3 months
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Standing height, without footwear, will be taken using stadiometer to the nearest 5mm
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baseline, pre-intervention, 1 day for each participant /during 3 months
|
Anthropometric measurements (Weight)
Time Frame: baseline, pre-intervention, 1 day for each participant /during 3 months
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Bioelectrical impedance will be used to determine body weight
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baseline, pre-intervention, 1 day for each participant /during 3 months
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Anthropometric measurements (waist circumference)
Time Frame: baseline, pre-intervention, 1 day for each participant /during 3 months
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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
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baseline, pre-intervention, 1 day for each participant /during 3 months
|
Anthropometric measurements (percentage body fat)
Time Frame: baseline, pre-intervention,1 day for each participant /during 3 months
|
Bioelectrical impedance will be used to determine body composition
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baseline, pre-intervention,1 day for each participant /during 3 months
|
Biochemical measurements (Total cholesterol (TC))
Time Frame: After the intervention / up to 3 months from collecting the samples
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Up to 6 hours
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After the intervention / up to 3 months from collecting the samples
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Biochemical measurements (Low density lipoprotein cholesterol (LDL))
Time Frame: Up to 6 hours
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Low-density lipoprotein cholesterol test will be performed after an overnight fast and 2, 4, and 6 hours after eating the meals
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Up to 6 hours
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Biochemical measurements ( High density lipoprotein cholesterol (HDL))
Time Frame: Up to 6 hours
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High-density lipoprotein cholesterol test will be performed after an overnight fast and 2, 4, and 6 hours after eating the meals
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Up to 6 hours
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Biochemical measurements (Triglyceride (TG))
Time Frame: Up to 6 hours
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Triglyceride test will be performed after an overnight fast and 2, 4, and 6 hours after eating the meals
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Up to 6 hours
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Dietary intake (3-days food record)
Time Frame: one day
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Participants will be asked to fill out a food record to track changes in their (intake) appetite
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one day
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Shatha S Hammad, PhD, The university of Jordan
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2022
Primary Completion (Actual)
October 1, 2022
Study Completion (Actual)
November 1, 2022
Study Registration Dates
First Submitted
June 13, 2022
First Submitted That Met QC Criteria
September 12, 2022
First Posted (Actual)
September 14, 2022
Study Record Updates
Last Update Posted (Actual)
August 29, 2023
Last Update Submitted That Met QC Criteria
August 27, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022/6
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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