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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05825963
• Other study ID #: IstanbulOkanU
• Status: Completed
• Phase: N/A
• Start date: April 12, 2022
• Est. completion date: August 17, 2022

Study information

• Verified date: January 2024
• Source: Okan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: August 17, 2022
• Est. primary completion date: April 26, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 35 Years

Eligibility

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).

Related Conditions & MeSH terms

• Appetitive Behavior
• Cardiovascular Diseases
• Food Preferences
• Hyperlipidemias
• Obesity

Intervention

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.

Locations

Country	Name	City	State
Turkey	Istanbul Okan University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Ahmet Murat Günal

Country where clinical trial is conducted

Turkey, 

References & Publications (15)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum In: J Am Diet Assoc. 2003 May;103(5):563. — View Citation

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. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postprandial changes in lipid profile	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
Primary	Postprandial changes in glycemia	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
Primary	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.	Change from baseline to 6th hours of each intervention
Primary	Changes in daily food intake	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