Effect of EverVita Pro, a Protein Rich Ingredient, on Satiety Measures, Subsequent Energy Intake, and Gastrointestinal Symptoms: A Randomized, Controlled, Cross-over Study in Healthy Subjects
Condition: Satiety of High Fiber High Protein Bread
Study type: Interventional

Summary: 
      This study will explore the satiating effect of EverVita Pro when consumed at breakfast on
      subsequent food intake. On 2 separate days, subjects will consume in random order a test
      breakfast (bread, butter, jam), either containing containing EverVita Pro or not (control),
      followed by an ad libitum pizza lunch 1.5 hours later. Before breakfast, after breakfast and
      after the pizza, subjects will fill in questionnaires regarding their motivation to eat
      (feelings of hunger/fullness). The hypothesis is that the EverVita Pro breakfast will result
      in less pizza consumption and prolonged feeling of fullness and satiety in comparison to the
      control bread.
    

Detailed description: 
      A standard breakfast meal will be consumed at each visit and it will contain either the test
      (EverVita Pro) or control product. The test meals and control meals are designed to be
      isocaloric. The portion size of the EverVitaPro or Control bread is matched in the calories
      equivalent to 3 slices of wholemeal bread.

      A (GI) symptoms questionnaire will be administered to assess GI tolerability: 1) before
      breakfast (0'), 2) before ad -libitum pizza lunch (90'), 3) before bedtime, and 4) before
      breakfast the following morning (24h). Comparison of satiety scores at each time point for
      each individual question between test and control over 2h. Subjective measurements of
      motivation to eat will be assessed using visual analog scales (VAS) by filling out the VAS
      motivation to eat questionnaire. For instance, fullness is assessed with the following
      statement on the left side of the line "not full at all" with the following statement to the
      right side of the line "As full as I have ever felt". Participants will place a vertical line
      along the horizontal line to the point that they feel reflects their feelings at that moment.
      Subjects will not be permitted to refer to their previous ratings when completing the VAS.

      Power calculation was done for a two-sided, two-sample t-test assuming equal variances and
      equal sample sizes for the two groups to detect a 700 KJ difference in intake between
      products using a non-central t-distribution.

      A sample size of 60 subjects, 30 per sequence, is sufficient to detect a 700 KJ difference in
      intake between products with 94% statistical power if the standard deviation for intake is as
      large as 1500 KJ.

      Randomization Individuals are allocated to the two sequence of preloads (EverVita Pro
      meal/Control meal and Control meal/EverVita Pro meal) completely at random.

      Statistical Analysis

      Primary Objective:

      The primary outcome (response) measured is the energy intake 90 min after preload
      administration.

      Secondary Objectives:

      Visual analogue scores (VAS) from 4 questions (Desire to eat, Hunger, Fullness, Prospective
      consumption) and gastrointestinal severity symptoms from 9 questions (Diarrhea, Vomiting,
      Abdominal distension, Hiccups, Stomach aches/abdominal pain, Constipation, Flatulence or gas
      in abdomen, Nausea, Indigestion) are evaluated as secondary outcomes.

      Data are presented as mean ± SEM unless stated otherwise. All statistical analyses are
      performed using R statistical software, version 3.6.3 (http://www.r-project.org/). All test
      are two-sided and a value of P < 0.05 is considered statistically significant.
    

Intervention name(s): EverVita Pro; Control bread
Intervention type(s): Other; Other
Intervention description(s): EverVita Pro is composed of barley and corn, grown and mechanically processed in Europe, with non-GMO grains.; Bread baked with normal Bakers flour
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: satiation, fullness, protein, fiber, hunger, bread