Nutrition, HealthyNCT05825963
Psyllium-enriched Hamburger Meatballs: Effects on Postprandial Lipidemia, Glycemia, Appetite, and Food Intake
A study testing Psyllium in people with Nutrition, Healthy and Appetitive Behavior, run by Ahmet Murat Günal at 1 site in Turkey (Türkiye).
Trial 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: 1. Read more about this study
- Who is it for?
- Ages 19 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Nutrition, Healthy, Appetitive Behavior, Food Preferences
- What is being tested?
- Psyllium
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Apr 2022to 17 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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:
- 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.
Read more
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.
Read the 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.
- Conditions
- Nutrition, Healthy, Appetitive Behavior, Food Preferences, Obesity, Cardiovascular Diseases
- Being tested
- Psyllium
- Keywords
- Psyllium, soluble fiber, hamburger, postprandial lipidemia, food intake, appetite
- Medical subject headings
- Appetitive Behavior, Food Preferences, Obesity, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsylliumDietary supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| PEHM/CHM | Experimental | In this arm, participants received psyllium-enriched hamburger meatballs first, then after the washout period, they received classic hamburger meatballs. Receives: Dietary Supplement: Psyllium |
| CHM/PEHM | Experimental | In this arm, participants received classic hamburger meatballs first, then after the washout period, they received psyllium-enriched hamburger meatballs. Receives: Dietary Supplement: Psyllium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postprandial changes in lipid profile
Comparison of participants' fasting and postprandial lipid levels according to the hamburgers consumed (mg/dL) will be conducted.
Measured: 0 and 2nd hours of each intervention
Postprandial changes in glycemia
Comparison of participants' fasting and postprandial glucose levels according to the hamburgers consumed (mg/dL) will be conducted.
Measured: 0 and 2nd hours of each intervention
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.
Measured: Change from baseline to 6th hours of each intervention
Changes in daily food intake
Comparison of participants' food intake according to the hamburgers consumed will be conducted using 24-hour food intake record.
Measured: Change from one day before to one day after of each intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2023
- Study start12 Apr 2022
- Primary completion26 Apr 2022
- Study completion17 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Nutrition, HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ahmet Murat Günal
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ahmet Murat Günal, Okan University
- Investigators
- Ahmet Murat Günal, Ph.D., Principal investigator, Okan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05825963
- Sponsor's protocol ID
- IstanbulOkanU
- Status last verified
- Jan 2024
- First submitted
- 24 Mar 2023
- Last updated
- 3 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected IPDs will be shared after publication.
Publications
Phan JL, Cowley JM, Neumann KA, Herliana L, O'Donovan LA, Burton RA. The novel features of Plantago ovata seed mucilage accumulation, storage and release. Sci Rep. 2020 Jul 16;10(1):11766. doi: 10.1038/s41598-020-68685-w.
PubMed 32678191Fischer MH, Yu N, Gray GR, Ralph J, Anderson L, Marlett JA. The gel-forming polysaccharide of psyllium husk (Plantago ovata Forsk). Carbohydr Res. 2004 Aug 2;339(11):2009-17. doi: 10.1016/j.carres.2004.05.023.
PubMed 15261594Gibb RD, McRorie JW Jr, Russell DA, Hasselblad V, D'Alessio DA. Psyllium fiber improves glycemic control proportional to loss of glycemic control: a meta-analysis of data in euglycemic subjects, patients at risk of type 2 diabetes mellitus, and patients being treated for type 2 diabetes mellitus. Am J Clin Nutr. 2015 Dec;102(6):1604-14. doi: 10.3945/ajcn.115.106989. Epub 2015 Nov 11.
PubMed 26561625McRorie JW Jr. Evidence-Based Approach to Fiber Supplements and Clinically Meaningful Health Benefits, Part 1: What to Look for and How to Recommend an Effective Fiber Therapy. Nutr Today. 2015 Mar;50(2):82-89. doi: 10.1097/NT.0000000000000082.
PubMed 25972618Wanders AJ, van den Borne JJ, de Graaf C, Hulshof T, Jonathan MC, Kristensen M, Mars M, Schols HA, Feskens EJ. Effects of dietary fibre on subjective appetite, energy intake and body weight: a systematic review of randomized controlled trials. Obes Rev. 2011 Sep;12(9):724-39. doi: 10.1111/j.1467-789X.2011.00895.x. Epub 2011 Jun 16.
PubMed 21676152Howarth NC, Saltzman E, Roberts SB. Dietary fiber and weight regulation. Nutr Rev. 2001 May;59(5):129-39. doi: 10.1111/j.1753-4887.2001.tb07001.x.
PubMed 11396693Trumbo P, Schlicker S, Yates AA, Poos M; Food and Nutrition Board of the Institute of Medicine, The National Academies. Dietary reference intakes for energy, carbohydrate, fiber, fat, fatty acids, cholesterol, protein and amino acids. J Am Diet Assoc. 2002 Nov;102(11):1621-30. doi: 10.1016/s0002-8223(02)90346-9. No abstract available.
PubMed 12449285Isganaitis E, Lustig RH. Fast food, central nervous system insulin resistance, and obesity. Arterioscler Thromb Vasc Biol. 2005 Dec;25(12):2451-62. doi: 10.1161/01.ATV.0000186208.06964.91. Epub 2005 Sep 15.
PubMed 16166564Schulz KF, Altman DG, Moher D. CONSORT 2010 statement: Updated guidelines for reporting parallel group randomised trials. J Pharmacol Pharmacother. 2010 Jul;1(2):100-7. doi: 10.4103/0976-500X.72352. No abstract available.
PubMed 21350618Khossousi A, Binns CW, Dhaliwal SS, Pal S. The acute effects of psyllium on postprandial lipaemia and thermogenesis in overweight and obese men. Br J Nutr. 2008 May;99(5):1068-75. doi: 10.1017/S0007114507864804. Epub 2007 Nov 16.
PubMed 18005484Pal S, Ho S, Gahler RJ, Wood S. Effect on Insulin, Glucose and Lipids in Overweight/Obese Australian Adults of 12 Months Consumption of Two Different Fibre Supplements in a Randomised Trial. Nutrients. 2017 Jan 29;9(2):91. doi: 10.3390/nu9020091.
PubMed 28146065Brennan MA, Derbyshire EJ, Brennan CS, Tiwari BK. Impact of dietary fibre-enriched ready-to-eat extruded snacks on the postprandial glycaemic response of non-diabetic patients. Mol Nutr Food Res. 2012 May;56(5):834-7. doi: 10.1002/mnfr.201100760.
PubMed 22648629Pal S, Khossousi A, Binns C, Dhaliwal S, Ellis V. The effect of a fibre supplement compared to a healthy diet on body composition, lipids, glucose, insulin and other metabolic syndrome risk factors in overweight and obese individuals. Br J Nutr. 2011 Jan;105(1):90-100. doi: 10.1017/S0007114510003132. Epub 2010 Aug 23.
PubMed 20727237Karhunen LJ, Juvonen KR, Flander SM, Liukkonen KH, Lahteenmaki L, Siloaho M, Laaksonen DE, Herzig KH, Uusitupa MI, Poutanen KS. A psyllium fiber-enriched meal strongly attenuates postprandial gastrointestinal peptide release in healthy young adults. J Nutr. 2010 Apr;140(4):737-44. doi: 10.3945/jn.109.115436. Epub 2010 Feb 10.
PubMed 20147463Brum JM, Gibb RD, Peters JC, Mattes RD. Satiety effects of psyllium in healthy volunteers. Appetite. 2016 Oct 1;105:27-36. doi: 10.1016/j.appet.2016.04.041. Epub 2016 May 7.
PubMed 27166077
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enrichment of Hamburger Meatballs With Psyllium and Determination of the Effects on Postprandial Lipidemia, Glycemia, Appetite, and Food Intake
- ClinicalTrials.gov ID
- NCT05825963
- Acronym / sponsor ID
- IstanbulOkanU
- Conditions
- Nutrition, Healthy, Appetitive Behavior, Food Preferences, Obesity, Cardiovascular Diseases
- Keywords
- Psyllium, soluble fiber, hamburger, postprandial lipidemia, food intake, appetite
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Ahmet Murat GünalUniversity, hospital or other
- Study start
- 12 Apr 2022 (actual)
- Primary completion
- 26 Apr 2022 (actual)
- Study completion
- 17 Aug 2022 (actual)
- First posted
- 24 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PEHM/CHM | Experimental | Dietary Supplement: PsylliumIn this arm, participants received psyllium-enriched hamburger meatballs first, then after the washout period, they received classic hamburger meatballs. |
| CHM/PEHM | Experimental | Dietary Supplement: PsylliumIn this arm, participants received classic hamburger meatballs first, then after the washout period, they received psyllium-enriched hamburger meatballs. |
Who may qualify
- Ages
- 19 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PsylliumThe 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. | Dietary supplement | CHM/PEHM, PEHM/CHM |
Primary outcome
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2024.
- Background: PubMed 32678191Phan JL, Cowley JM, Neumann KA, Herliana L, O'Donovan LA, Burton RA. The novel features of Plantago ovata seed mucilage accumulation, storage and release. Sci Rep. 2020 Jul 16;10(1):11766. doi: 10.1038/s41598-020-68685-w.
- Background: PubMed 15261594Fischer MH, Yu N, Gray GR, Ralph J, Anderson L, Marlett JA. The gel-forming polysaccharide of psyllium husk (Plantago ovata Forsk). Carbohydr Res. 2004 Aug 2;339(11):2009-17. doi: 10.1016/j.carres.2004.05.023.
- Background: PubMed 26561625Gibb RD, McRorie JW Jr, Russell DA, Hasselblad V, D'Alessio DA. Psyllium fiber improves glycemic control proportional to loss of glycemic control: a meta-analysis of data in euglycemic subjects, patients at risk of type 2 diabetes mellitus, and patients being treated for type 2 diabetes mellitus. Am J Clin Nutr. 2015 Dec;102(6):1604-14. doi: 10.3945/ajcn.115.106989. Epub 2015 Nov 11.
- Background: PubMed 25972618McRorie JW Jr. Evidence-Based Approach to Fiber Supplements and Clinically Meaningful Health Benefits, Part 1: What to Look for and How to Recommend an Effective Fiber Therapy. Nutr Today. 2015 Mar;50(2):82-89. doi: 10.1097/NT.0000000000000082.
- Background: PubMed 21676152Wanders AJ, van den Borne JJ, de Graaf C, Hulshof T, Jonathan MC, Kristensen M, Mars M, Schols HA, Feskens EJ. Effects of dietary fibre on subjective appetite, energy intake and body weight: a systematic review of randomized controlled trials. Obes Rev. 2011 Sep;12(9):724-39. doi: 10.1111/j.1467-789X.2011.00895.x. Epub 2011 Jun 16.
- Background: PubMed 11396693Howarth NC, Saltzman E, Roberts SB. Dietary fiber and weight regulation. Nutr Rev. 2001 May;59(5):129-39. doi: 10.1111/j.1753-4887.2001.tb07001.x.
- Background: PubMed 12449285Trumbo P, Schlicker S, Yates AA, Poos M; Food and Nutrition Board of the Institute of Medicine, The National Academies. Dietary reference intakes for energy, carbohydrate, fiber, fat, fatty acids, cholesterol, protein and amino acids. J Am Diet Assoc. 2002 Nov;102(11):1621-30. doi: 10.1016/s0002-8223(02)90346-9. No abstract available.
- Background: PubMed 16166564Isganaitis E, Lustig RH. Fast food, central nervous system insulin resistance, and obesity. Arterioscler Thromb Vasc Biol. 2005 Dec;25(12):2451-62. doi: 10.1161/01.ATV.0000186208.06964.91. Epub 2005 Sep 15.
- Background: PubMed 21350618Schulz KF, Altman DG, Moher D. CONSORT 2010 statement: Updated guidelines for reporting parallel group randomised trials. J Pharmacol Pharmacother. 2010 Jul;1(2):100-7. doi: 10.4103/0976-500X.72352. No abstract available.
- Background: PubMed 18005484Khossousi A, Binns CW, Dhaliwal SS, Pal S. The acute effects of psyllium on postprandial lipaemia and thermogenesis in overweight and obese men. Br J Nutr. 2008 May;99(5):1068-75. doi: 10.1017/S0007114507864804. Epub 2007 Nov 16.
- Background: PubMed 28146065Pal S, Ho S, Gahler RJ, Wood S. Effect on Insulin, Glucose and Lipids in Overweight/Obese Australian Adults of 12 Months Consumption of Two Different Fibre Supplements in a Randomised Trial. Nutrients. 2017 Jan 29;9(2):91. doi: 10.3390/nu9020091.
- Background: PubMed 22648629Brennan MA, Derbyshire EJ, Brennan CS, Tiwari BK. Impact of dietary fibre-enriched ready-to-eat extruded snacks on the postprandial glycaemic response of non-diabetic patients. Mol Nutr Food Res. 2012 May;56(5):834-7. doi: 10.1002/mnfr.201100760.
- Individual participant dataSharing planned: Yes. All collected IPDs will be shared after publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmet Murat Günal, Ph.D. principal investigator
Okan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psyllium in people with Nutrition, Healthy and Appetitive Behavior, run by Ahmet Murat Günal at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postprandial changes in lipid profile (time frame: 0 and 2nd hours of each intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05825963, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2024.