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

NCT05825963 | Completed

• 1 other identifier: IstanbulOkanU
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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:

• 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.

Conditions

Nutrition, Healthy; Appetitive Behavior; Food Preferences; Obesity; Cardiovascular Diseases

Keywords

Psyllium; soluble fiber; hamburger; postprandial lipidemia; food intake; appetite

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Study Arms (2)

PEHM/CHM

EXPERIMENTAL

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

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.

Dietary Supplement: Psyllium

Interventions

Psyllium DIETARY_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.

CHM/PEHM; PEHM/CHM

Eligibility Criteria

• Age: 19 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Ahmet Murat Günal: lead

Study Sites (1)

İstanbul Okan University

Istanbul, 34000, Turkey (Türkiye)

Location

Related Publications (16)

• 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.

  PMID: 32678191 BACKGROUND

• 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.

  PMID: 15261594 BACKGROUND

• 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.

  PMID: 26561625 BACKGROUND

• 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.

  PMID: 25972618 BACKGROUND

• 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.

  PMID: 21676152 BACKGROUND

• 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.

  PMID: 11396693 BACKGROUND

• 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.

  PMID: 12449285 BACKGROUND

• 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.

  PMID: 16166564 BACKGROUND

• 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.

  PMID: 21350618 BACKGROUND

• 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.

  PMID: 18005484 BACKGROUND

• 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.

  PMID: 28146065 BACKGROUND

• 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.

  PMID: 22648629 BACKGROUND

• 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.

  PMID: 20727237 BACKGROUND

• 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.

  PMID: 20147463 BACKGROUND

• 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.

  PMID: 27166077 BACKGROUND

• 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.

  PMID: 41078451 DERIVED

MeSH Terms

Conditions

Appetitive Behavior; Food Preferences; Obesity; Cardiovascular Diseases

Interventions

Psyllium

Condition Hierarchy (Ancestors)

Behavior, Animal; Behavior; Feeding Behavior; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Plant Extracts; Plant Preparations; Biological Products; Complex Mixtures

Study Officials

• Ahmet Murat Günal, Ph.D.

  Okan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Triple blind study design
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor Doctor

Study Record Dates

• First Submitted: March 24, 2023
• First Posted: April 24, 2023
• Study Start: April 12, 2022
• Primary Completion: April 26, 2022
• Study Completion: August 17, 2022
• Last Updated: January 3, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 3 mounts after publication
• Access Criteria: For systematic review and meta-analyses.

Locations

TU (1)