NCT05539742

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2022

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

June 13, 2022

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 14, 2022

Completed
17 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2022

Completed
Last Updated

August 29, 2023

Status Verified

August 1, 2023

Enrollment Period

4 months

First QC Date

June 13, 2022

Last Update Submit

August 27, 2023

Conditions

Keywords

Postprandial lipemia

Outcome Measures

Primary Outcomes (9)

  • 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

  • Anthropometric measurements (Weight)

    Bioelectrical impedance will be used to determine body weight

    baseline, pre-intervention, 1 day for each participant /during 3 months

  • 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

  • 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

  • Biochemical measurements (Total cholesterol (TC))

    Up to 6 hours

    After the intervention / up to 3 months from collecting the samples

  • 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

  • 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

  • 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

  • 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

Study Arms (2)

Coconut oil

ACTIVE COMPARATOR

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.

Dietary Supplement: Coconut oil

Palm oil

ACTIVE COMPARATOR

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.

Dietary Supplement: Palm oil

Interventions

Coconut oilDIETARY_SUPPLEMENT

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

Coconut oil
Palm oilDIETARY_SUPPLEMENT

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

Palm oil

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

The University of Jordan

Amman, 11942, Jordan

Location

The University of Jordan

Amman, Jordan

Location

Related Publications (23)

  • 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.

    PMID: 32684486BACKGROUND
  • 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.

    PMID: 25473503BACKGROUND
  • 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.

    PMID: 33261509BACKGROUND
  • 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.

    PMID: 27752194BACKGROUND
  • 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.

    PMID: 32733374BACKGROUND
  • 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.

    PMID: 28923057BACKGROUND
  • 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.

    PMID: 34065380BACKGROUND
  • 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.

    PMID: 22331686BACKGROUND
  • 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.

    PMID: 28098139BACKGROUND
  • 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.

    PMID: 29511019BACKGROUND
  • 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.

    PMID: 31319633BACKGROUND
  • 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.

    PMID: 23275359BACKGROUND
  • 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.

    PMID: 34136161BACKGROUND
  • 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.

    PMID: 24816555BACKGROUND
  • 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.

    PMID: 30239550BACKGROUND
  • 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.

    PMID: 30824268BACKGROUND
  • 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.

    PMID: 24673475BACKGROUND
  • 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.

    PMID: 27080715BACKGROUND
  • 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.

    PMID: 24388214BACKGROUND
  • 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.

    PMID: 26232169BACKGROUND
  • 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.

    PMID: 21804620BACKGROUND
  • 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.

    PMID: 21676342BACKGROUND
  • Jadallah R, Hammad SS. Comparison of the effect of medium-chain fatty acids and long-chain fatty acids on postprandial appetite and lipemia: a randomised crossover trial. BMJ Nutr Prev Health. 2024 Dec 11;7(2):e001029. doi: 10.1136/bmjnph-2024-001029. eCollection 2024.

MeSH Terms

Conditions

Hyperlipidemias

Interventions

Coconut OilPalm Oil

Condition Hierarchy (Ancestors)

DyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Dietary FatsFatsLipidsPlant OilsOilsPlant PreparationsBiological ProductsComplex Mixtures

Study Officials

  • Shatha S Hammad, PhD

    The University of Jordan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: randomized crossover single-blinded intervention study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 13, 2022

First Posted

September 14, 2022

Study Start

June 1, 2022

Primary Completion

October 1, 2022

Study Completion

November 1, 2022

Last Updated

August 29, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations