Psyllium-enriched Hamburger Meatballs: Effects on Postprandial Lipidemia, Glycemia, Appetite, and Food Intake
Condition: Nutrition, Healthy; Appetitive Behavior; Food Preferences; Obesity; Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases; Hyperlipidemias
Study type: Interventional

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.
    

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.
    

Intervention name(s): Psyllium
Intervention type(s): Dietary Supplement
Intervention description(s): 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.
Intervention MeSH terms: Psyllium
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Psyllium; soluble fiber; hamburger; postprandial lipidemia; food intake; appetite