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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

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ClinicalTrials.gov Identifier: NCT04869215
Recruitment Status : Not yet recruiting
First Posted : May 3, 2021
Last Update Posted : May 3, 2021
Sponsor:
Collaborator:
INQUIS Clinical Research
Information provided by (Responsible Party):
Evergrain, LLC

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Satiety of High Fiber High Protein Bread Other: EverVita Pro Other: Control bread Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: 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
Estimated Study Start Date : May 2021
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: EverVita Pro consumed at breakfast followed by an ad lib meal
Before breakfast, a Motivation to Eat and a GI symptom questionnaire will be completed. They will then be given a standard breakfast which will include EverVita Pro bread, followed by an ad lib pizza meal 1.5h later. Subjects will be asked to fill out the VAS Motivation to Eat Questionnaire before being given the meal and at 10-minute intervals after they start consuming the test meal until they are given the ad lib pizza meal and 30 min after the start of the ad lib pizza meal.
 Other: EverVita Pro
EverVita Pro is composed of barley and corn, grown and mechanically processed in Europe, with non-GMO grains.
Placebo Comparator: Control consumed at breakfast followed by an ad lib meal.
Before breakfast, a Motivation to Eat and a GI symptom questionnaire will be completed. They will then be given a standard breakfast which will include the control bread, followed by an ad lib pizza meal 1.5h later. Subjects will be asked to fill out the VAS Motivation to Eat Questionnaire before being given the meal and at 10-minute intervals after they start consuming the test meal until they are given the ad lib pizza meal and 30 min after the start of the ad lib pizza meal.
 Other: Control bread
Bread baked with normal Bakers flour


Outcome Measures
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Primary Outcome Measures :
  1. Energy intake comparison [ Time Frame: at time point 1.5 hours ]
    Compare energy intake from the ad libitum pizza meal following the EverVita Pro containing meal and a control meal.


Secondary Outcome Measures :
  1. Satiety scores from VAS per individual [ Time Frame: every 10 minutes for 90 minutes, then after 120 minutes again ]
    Compare satiety scores at each time point for each individual question between EverVita Protest and control over 2h

  2. Satiety scores from VAS between individuals [ Time Frame: every 10 minutes for 90 minutes, then after 120 minutes again ]
    Compare composite satiety score at each time point between EverVita Pro and control over 2h

  3. Gastrointestinal effects via GI symptoms questionnaire [ Time Frame: at t=0, after 90 minutes, before bed time and 24 hours after start intervention ]
    Compare the incidence and severity of GI symptoms after ingestion of EverVita Pro with a control over 24h


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Body mass index (BMI) between 18 and 30kg/m2, inclusive
  • No major illness or surgery requiring hospitalization within 3 months of the screening visit
  • Subjects must be eligible to receive income in Canada.
  • Understanding Subjects must understand the study procedures and be willing to provide informed consent to participate in the study
  • Individuals who are able to become pregnant are willing to avoid pregnancy during the study period

Exclusion Criteria:

  • Failure to meet all the inclusion criteria
  • Smokers (cigarettes, vape, cannabis)
  • Pregnant or breastfeeding (self-reported)
  • Known history of diabetes, liver disease, renal failure, gallstone disease, significant cardiovascular disease, major psychiatric disorders or other medical conditions which might, in the opinion of the Principal Investigator (PI), either 1) make participation dangerous to the subject or to others, 2) affect the results, or 3) influence the ability of the subject to comply with study procedures
  • Use of any drug which would interfere with appetite, in the opinion of the PI.
  • Unwillingness or inability to comply with the experimental procedures and to follow INQUIS safety guidelines
  • Known intolerance, sensitivity or allergy to any ingredients in the study products
  • History of cancer in the prior two years, except for non-melanoma skin cancer
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04869215


Contacts
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Contact: Janice Campbell 416-861-0506 ext 201 jcampbell@inquis.com

Locations
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Canada, Ontario
INQUIS Clinical Research
Toronto, Ontario, Canada, M5C2N8
Contact: Janice Campbell, MSc         
Principal Investigator: Thomas Wolever, MD, PhD         
Sponsors and Collaborators
Evergrain, LLC
INQUIS Clinical Research
Investigators
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Principal Investigator: Thomas Wolever, DM, PhD INQUIS Clinical Research
More Information
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Responsible Party: Evergrain, LLC
ClinicalTrials.gov Identifier: NCT04869215    
Other Study ID Numbers: Satiety EVP in bread
First Posted: May 3, 2021    Key Record Dates
Last Update Posted: May 3, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Evergrain, LLC:
satiation, fullness, protein, fiber, hunger, bread