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Psyllium-enriched Hamburger Meatballs: Effects on Postprandial Lipidemia, Glycemia, Appetite, and Food Intake

Primary Purpose

Nutrition, Healthy, Appetitive Behavior, Food Preferences

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Psyllium
Sponsored by
Ahmet Murat Günal
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Nutrition, Healthy focused on measuring Psyllium, soluble fiber, hamburger, postprandial lipidemia, food intake, appetite

Eligibility Criteria

19 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Being willing to participate in the research Aged 19 to 35 No chronic or metabolic disorders Body mass index (BMI) between 18.5 and 25 kg/m2 Exclusion Criteria: Not being willing to participate in the research, Having chronic diseases such as diabetes, hypertension, cancer, metabolic syndrome, chronic kidney disease, dyslipidemia, etc. Having a congenital metabolic disease, Taking medication to lower blood lipids, Being pregnant or breastfeeding, Being vegan or vegetarian (as the study requires meat consumption).

Sites / Locations

  • İstanbul Okan University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

PEHM/CHM

CHM/PEHM

Arm Description

In this arm, participants received psyllium-enriched hamburger meatballs first, then after the washout period, they received classic hamburger meatballs.

In this arm, participants received classic hamburger meatballs first, then after the washout period, they received psyllium-enriched hamburger meatballs.

Outcomes

Primary Outcome Measures

Postprandial changes in lipid profile
Comparison of participants' fasting and postprandial lipid levels according to the hamburgers consumed (mg/dL) will be conducted.
Postprandial changes in glycemia
Comparison of participants' fasting and postprandial glucose levels according to the hamburgers consumed (mg/dL) will be conducted.
Postprandial changes in satiety and hunger
Comparison of participants' subjective evaluations of hunger and satiety according to the hamburgers consumed will be conducted using visual analog scale (VAS). Which is a 100mm horizontal scale, indicating stronger feelings (satiety, hunger) toward 100.
Changes in daily food intake
Comparison of participants' food intake according to the hamburgers consumed will be conducted using 24-hour food intake record.

Secondary Outcome Measures

Full Information

First Posted
March 24, 2023
Last Updated
April 11, 2023
Sponsor
Ahmet Murat Günal
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1. Study Identification

Unique Protocol Identification Number
NCT05825963
Brief Title
Psyllium-enriched Hamburger Meatballs: Effects on Postprandial Lipidemia, Glycemia, Appetite, and Food Intake
Official Title
Enrichment of Hamburger Meatballs With Psyllium and Determination of the Effects on Postprandial Lipidemia, Glycemia, Appetite, and Food Intake
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
April 12, 2022 (Actual)
Primary Completion Date
April 26, 2022 (Actual)
Study Completion Date
August 17, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ahmet Murat Günal

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 goal of this clinical trial is to enrich the hamburger meatball with psyllium without impairing its sensory properties and to investigate the effects on acute postprandial lipemia and glycemia, prospective food intake, and some appetite indicators in healthy adults. The main hypotheses of the study are: There is no difference in sensory analysis results between hamburger meatballs enriched with psyllium and those that are not enriched. The rise in postprandial lipids after consuming psyllium-enriched hamburger meatballs is lower than that of classic hamburgers. The rise in postprandial glycemia after consuming psyllium-enriched hamburger meatballs is lower than that of classic hamburgers. The feeling of satiety after consuming psyllium-enriched hamburger meatballs lasts longer, and the feeling of hunger lasts for a shorter period compared to classic hamburgers. Daily food intake after consuming psyllium-enriched hamburger meatballs is less than that of classic hamburgers. Participants will, Eat hamburgers, after fasting for 12 hours, with psyllium-enriched and classic meatballs on intervention days. Keep a record of their food intake for the previous and following 24 hours of each intervention. Be given fasting and postprandial blood samples. Evaluate their hunger and satiety levels on a 100 mm horizontal visual analog scale (VAS) at the beginning and every hour for the following 6 hours of the study.
Detailed Description
After preparing 7.5% psyllium-enriched hamburger meatballs (PEHMs) and control hamburger meatballs (CHMs), they will be placed in identical storage containers and frozen at -18°C in a deep freezer. An independent academic will use the Google Random Number Generator to randomly assign two three-digit numbers and code each group accordingly to ensure that the experimental period will be triple-blind. Participants will be asked to keep a record of their food intake for the previous 24 hours, avoid heavy physical activity, abstain from alcohol before the first day of the study, and to arrive at the study in a state of fasting for 12 hours. On the study day, the participants' sociodemographic information will be collected, anthropometric measurements (height, weight, and fat percentage) will be taken, and fasting blood samples will be collected by a nurse. The participants will then select hamburgers randomly by themselves, with or without (control) 12 g of psyllium, each containing 85 g of hamburger bread, 160 g of 20% fat beef, 2.56 g of salt, and 1.28 g of pepper. They will be asked to consume them with 200 ml of water. The codes for the hamburgers will be written under the plate. The researcher will record which participant consumed which coded hamburger. After waiting two hours in a designated room, postprandial blood samples will be collected in the same order and sent for analysis. After analyzing the fasting blood values of the participants, if any of them have dyslipidemia (LDL> 149) will be excluded from the study. The remaining participants will be invited back for the second day of the study following a two-week washout period. On this day, the hamburger that they did not consume on the first day will be served to them and the same procedure will repeat. The guidelines outlined in the CONSORT 2010 statement will be followed during the conduct of the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nutrition, Healthy, Appetitive Behavior, Food Preferences, Obesity, Cardiovascular Diseases
Keywords
Psyllium, soluble fiber, hamburger, postprandial lipidemia, food intake, appetite

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Triple blind study design
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PEHM/CHM
Arm Type
Experimental
Arm Description
In this arm, participants received psyllium-enriched hamburger meatballs first, then after the washout period, they received classic hamburger meatballs.
Arm Title
CHM/PEHM
Arm Type
Experimental
Arm Description
In this arm, participants received classic hamburger meatballs first, then after the washout period, they received psyllium-enriched hamburger meatballs.
Intervention Type
Dietary Supplement
Intervention Name(s)
Psyllium
Intervention Description
The participants select hamburgers randomly by themselves, with or without (control) 12 g of psyllium, each containing 85 g of hamburger bread, 160 g of 20% fat beef, 2.56 g of salt, and 1.28 g of pepper, and asked to consume them with 200 ml of water.
Primary Outcome Measure Information:
Title
Postprandial changes in lipid profile
Description
Comparison of participants' fasting and postprandial lipid levels according to the hamburgers consumed (mg/dL) will be conducted.
Time Frame
0 and 2nd hours of each intervention
Title
Postprandial changes in glycemia
Description
Comparison of participants' fasting and postprandial glucose levels according to the hamburgers consumed (mg/dL) will be conducted.
Time Frame
0 and 2nd hours of each intervention
Title
Postprandial changes in satiety and hunger
Description
Comparison of participants' subjective evaluations of hunger and satiety according to the hamburgers consumed will be conducted using visual analog scale (VAS). Which is a 100mm horizontal scale, indicating stronger feelings (satiety, hunger) toward 100.
Time Frame
Change from baseline to 6th hours of each intervention
Title
Changes in daily food intake
Description
Comparison of participants' food intake according to the hamburgers consumed will be conducted using 24-hour food intake record.
Time Frame
Change from one day before to one day after of each intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Being willing to participate in the research Aged 19 to 35 No chronic or metabolic disorders Body mass index (BMI) between 18.5 and 25 kg/m2 Exclusion Criteria: Not being willing to participate in the research, Having chronic diseases such as diabetes, hypertension, cancer, metabolic syndrome, chronic kidney disease, dyslipidemia, etc. Having a congenital metabolic disease, Taking medication to lower blood lipids, Being pregnant or breastfeeding, Being vegan or vegetarian (as the study requires meat consumption).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmet Murat Günal, Ph.D.
Organizational Affiliation
Okan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
İstanbul Okan University
City
Istanbul
ZIP/Postal Code
34000
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All collected IPDs will be shared after publication.
IPD Sharing Time Frame
3 mounts after publication
IPD Sharing Access Criteria
For systematic review and meta-analyses.
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Psyllium-enriched Hamburger Meatballs: Effects on Postprandial Lipidemia, Glycemia, Appetite, and Food Intake

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