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

January 2, 2024 updated by: Ahmet Murat Günal

Enrichment of Hamburger Meatballs With Psyllium and Determination of the Effects on Postprandial Lipidemia, Glycemia, Appetite, and Food Intake

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:

  1. There is no difference in sensory analysis results between hamburger meatballs enriched with psyllium and those that are not enriched.
  2. The rise in postprandial lipids after consuming psyllium-enriched hamburger meatballs is lower than that of classic hamburgers.
  3. The rise in postprandial glycemia after consuming psyllium-enriched hamburger meatballs is lower than that of classic hamburgers.
  4. 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.
  5. 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

28

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

  • Turkey
      • Istanbul, Turkey, 34000
        • Istanbul Okan University

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

  • Adult

Accepts Healthy Volunteers

Yes

Description

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).

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: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PEHM/CHM
In this arm, participants received psyllium-enriched hamburger meatballs first, then after the washout period, they received classic hamburger meatballs.
Dietary supplement: Psyllium
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.
Experimental: CHM/PEHM
In this arm, participants received classic hamburger meatballs first, then after the washout period, they received psyllium-enriched hamburger meatballs.
Dietary supplement: Psyllium
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postprandial changes in lipid profile
Time Frame: 0 and 2nd hours of each intervention
Comparison of participants' fasting and postprandial lipid levels according to the hamburgers consumed (mg/dL) will be conducted.
0 and 2nd hours of each intervention
Postprandial changes in glycemia
Time Frame: 0 and 2nd hours of each intervention
Comparison of participants' fasting and postprandial glucose levels according to the hamburgers consumed (mg/dL) will be conducted.
0 and 2nd hours of each intervention
Postprandial changes in satiety and hunger
Time Frame: Change from baseline to 6th hours of each intervention
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.
Change from baseline to 6th hours of each intervention
Changes in daily food intake
Time Frame: Change from one day before to one day after of each intervention
Comparison of participants' food intake according to the hamburgers consumed will be conducted using 24-hour food intake record.
Change from one day before to one day after of each intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ahmet Murat Günal

Investigators

  • Principal Investigator: Ahmet Murat Günal, Ph.D., Okan University

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

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)

April 12, 2022

Primary Completion (Actual)

April 26, 2022

Study Completion (Actual)

August 17, 2022

Study Registration Dates

First Submitted

March 24, 2023

First Submitted That Met QC Criteria

April 11, 2023

First Posted (Actual)

April 24, 2023

Study Record Updates

Last Update Posted (Estimated)

January 3, 2024

Last Update Submitted That Met QC Criteria

January 2, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IstanbulOkanU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

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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