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Comparison of the Effect of MCFA and LCFA on Postprandial Appetite and Lipemia

Primary Purpose

Lipemia

Status
Completed
Phase
Not Applicable
Locations
Jordan
Study Type
Interventional
Intervention
Coconut oil
Palm oil
Sponsored by
University of Jordan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lipemia focused on measuring Postprandial lipemia

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • The University of Jordan
  • The University of Jordan

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Coconut oil

Palm oil

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Anthropometric measurements ( Height)
Standing height, without footwear, will be taken using stadiometer to the nearest 5mm
Anthropometric measurements (Weight)
Bioelectrical impedance will be used to determine body weight
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
Anthropometric measurements (percentage body fat)
Bioelectrical impedance will be used to determine body composition
Biochemical measurements (Total cholesterol (TC))
Up to 6 hours
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
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
Biochemical measurements (Triglyceride (TG))
Triglyceride test will be performed after an overnight fast and 2, 4, and 6 hours after eating the meals
Dietary intake (3-days food record)
Participants will be asked to fill out a food record to track changes in their (intake) appetite

Secondary Outcome Measures

Full Information

First Posted
June 13, 2022
Last Updated
August 27, 2023
Sponsor
University of Jordan
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1. Study Identification

Unique Protocol Identification Number
NCT05539742
Brief Title
Comparison of the Effect of MCFA and LCFA on Postprandial Appetite and Lipemia
Official Title
Comparison of the Effect of Medium-Chain Fatty Acids and Long-Chain Fatty Acids on Postprandial Appetite and Lipemia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
June 1, 2022 (Actual)
Primary Completion Date
October 1, 2022 (Actual)
Study Completion Date
November 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Jordan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lipemia
Keywords
Postprandial lipemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
randomized crossover single-blinded intervention study
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Coconut oil
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Palm oil
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Coconut oil
Intervention Description
Coconut oil will be given to each participant in the amount of 40 g, which will be incorporated into biscuits.
Intervention Type
Dietary Supplement
Intervention Name(s)
Palm oil
Intervention Description
Palm oil will be given to each participant in the amount of 40 g, which will be incorporated into biscuits.
Primary Outcome Measure Information:
Title
Anthropometric measurements ( Height)
Description
Standing height, without footwear, will be taken using stadiometer to the nearest 5mm
Time Frame
baseline, pre-intervention, 1 day for each participant /during 3 months
Title
Anthropometric measurements (Weight)
Description
Bioelectrical impedance will be used to determine body weight
Time Frame
baseline, pre-intervention, 1 day for each participant /during 3 months
Title
Anthropometric measurements (waist circumference)
Description
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
Time Frame
baseline, pre-intervention, 1 day for each participant /during 3 months
Title
Anthropometric measurements (percentage body fat)
Description
Bioelectrical impedance will be used to determine body composition
Time Frame
baseline, pre-intervention,1 day for each participant /during 3 months
Title
Biochemical measurements (Total cholesterol (TC))
Description
Up to 6 hours
Time Frame
After the intervention / up to 3 months from collecting the samples
Title
Biochemical measurements (Low density lipoprotein cholesterol (LDL))
Description
Low-density lipoprotein cholesterol test will be performed after an overnight fast and 2, 4, and 6 hours after eating the meals
Time Frame
Up to 6 hours
Title
Biochemical measurements ( High density lipoprotein cholesterol (HDL))
Description
High-density lipoprotein cholesterol test will be performed after an overnight fast and 2, 4, and 6 hours after eating the meals
Time Frame
Up to 6 hours
Title
Biochemical measurements (Triglyceride (TG))
Description
Triglyceride test will be performed after an overnight fast and 2, 4, and 6 hours after eating the meals
Time Frame
Up to 6 hours
Title
Dietary intake (3-days food record)
Description
Participants will be asked to fill out a food record to track changes in their (intake) appetite
Time Frame
one day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shatha S Hammad, PhD
Organizational Affiliation
The University of Jordan
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Jordan
City
Amman
ZIP/Postal Code
11942
Country
Jordan
Facility Name
The University of Jordan
City
Amman
Country
Jordan

12. IPD Sharing Statement

Plan to Share IPD
No
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Comparison of the Effect of MCFA and LCFA on Postprandial Appetite and Lipemia

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