- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04869215
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
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ontario
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Toronto, Ontario, Canada, M5C2N8
- Inquis Clinical research
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / 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.
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EverVita Pro is composed of barley and corn, grown and mechanically processed in Europe, with non-GMO grains.
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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.
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Bread baked with normal Bakers flour
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Energy intake comparison
Time Frame: at time point 1.5 hours
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Compare energy intake from the ad libitum pizza meal following the EverVita Pro containing meal and a control meal.
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at time point 1.5 hours
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Satiety scores from VAS per individual
Time Frame: every 10 minutes for 90 minutes, then after 120 minutes again
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Compare satiety scores at each time point for each individual question between EverVita Protest and control over 2h
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every 10 minutes for 90 minutes, then after 120 minutes again
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Satiety scores from VAS between individuals
Time Frame: every 10 minutes for 90 minutes, then after 120 minutes again
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Compare composite satiety score at each time point between EverVita Pro and control over 2h
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every 10 minutes for 90 minutes, then after 120 minutes again
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Gastrointestinal effects via GI symptoms questionnaire
Time Frame: at t=0, after 90 minutes, before bed time and 24 hours after start intervention
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Compare the incidence and severity of GI symptoms after ingestion of EverVita Pro with a control over 24h
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at t=0, after 90 minutes, before bed time and 24 hours after start intervention
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Thomas Wolever, DM, PhD, INQUIS Clinical Research Ltd.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Satiety EVP in bread
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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