Psyllium-enriched Hamburger Meatballs: Effects on Postprandial Lipidemia, Glycemia, Appetite, and Food Intake
NCT ID: NCT05825963
Last Updated: 2024-01-03
Study Results
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Basic Information
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COMPLETED
NA
28 participants
INTERVENTIONAL
2022-04-12
2022-08-17
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
QUADRUPLE
Study Groups
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PEHM/CHM
In this arm, participants received psyllium-enriched hamburger meatballs first, then after the washout period, they received classic hamburger meatballs.
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.
CHM/PEHM
In this arm, participants received classic hamburger meatballs first, then after the washout period, they received psyllium-enriched hamburger meatballs.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Aged 19 to 35
* No chronic or metabolic disorders
* Body mass index (BMI) between 18.5 and 25 kg/m2
Exclusion Criteria
* 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).
19 Years
35 Years
ALL
Yes
Sponsors
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Ahmet Murat Günal
OTHER
Responsible Party
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Ahmet Murat Günal
Assistant Professor Doctor
Principal Investigators
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Ahmet Murat Günal, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Okan University
Locations
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İstanbul Okan University
Istanbul, , Turkey (Türkiye)
Countries
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References
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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.
Fischer 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.
Gibb 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.
McRorie 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.
Wanders 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.
Howarth 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.
Trumbo 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.
Isganaitis 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.
Schulz 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.
Khossousi 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.
Pal 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.
Brennan 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.
Pal 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.
Karhunen 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.
Brum 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.
Gunal AM, Ongun Yilmaz H, Bas M. Enrichment of Hamburger Meatballs With Psyllium: Effects on Postprandial Lipidemia, Glycemia, Appetite, and Food Intake in a Triple-Blind Randomized Controlled Crossover Trial. Food Sci Nutr. 2025 Oct 9;13(10):e71066. doi: 10.1002/fsn3.71066. eCollection 2025 Oct.
Other Identifiers
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IstanbulOkanU
Identifier Type: -
Identifier Source: org_study_id
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