Satiety of High Fiber High Protein BreadNCT04869215
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
A study testing EverVita Pro in people with Satiety of High Fiber High Protein Bread, run by Evergrain, LLC at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Satiety of High Fiber High Protein Bread
- What is being tested?
- EverVita Pro
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 22 Jun 2021to 17 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Satiety of High Fiber High Protein Bread
- Being tested
- EverVita Pro, Control bread
- Keywords
- satiation, fullness, protein, fiber, hunger, bread
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EverVita ProOther
EverVita Pro is composed of barley and corn, grown and mechanically processed in Europe, with non-GMO grains.
Control breadOther
Bread baked with normal Bakers flour
| Study group | Role | What they receive |
|---|---|---|
| EverVita Pro consumed at breakfast followed by an ad lib meal | Experimental | 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. Receives: Other: EverVita Pro |
| Control consumed at breakfast followed by an ad lib meal. | Placebo comparator | 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. Receives: Other: Control bread |
What is being measured
The primary outcome is the main question the study is designed to answer.
Energy intake comparison
Compare energy intake from the ad libitum pizza meal following the EverVita Pro containing meal and a control meal.
Measured: at time point 1.5 hours
Secondary outcomes (3)
Satiety scores from VAS per individual
Compare satiety scores at each time point for each individual question between EverVita Protest and control over 2h
Measured: every 10 minutes for 90 minutes, then after 120 minutes again
Satiety scores from VAS between individuals
Compare composite satiety score at each time point between EverVita Pro and control over 2h
Measured: every 10 minutes for 90 minutes, then after 120 minutes again
Gastrointestinal effects via GI symptoms questionnaire
Compare the incidence and severity of GI symptoms after ingestion of EverVita Pro with a control over 24h
Measured: at t=0, after 90 minutes, before bed time and 24 hours after start intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2021
- Study start22 Jun 2021
- Primary completion17 Sep 2021
- Study completion17 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Satiety of High Fiber High Protein BreadStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Evergrain, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- INQUIS Clinical Research
- Responsible party
- Sponsor
- Investigators
- Thomas Wolever, DM, PhD, Principal investigator, INQUIS Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04869215
- Sponsor's protocol ID
- Satiety EVP in bread
- Status last verified
- Jul 2022
- First submitted
- 29 Apr 2021
- Last updated
- 28 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04869215
- Acronym / sponsor ID
- Satiety EVP in bread
- Conditions
- Satiety of High Fiber High Protein Bread
- Keywords
- satiation, fullness, protein, fiber, hunger, bread
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Evergrain, LLCIndustry (pharma, biotech, devices)
- Collaborators
- INQUIS Clinical Research
- Study start
- 22 Jun 2021 (actual)
- Primary completion
- 17 Sep 2021 (actual)
- Study completion
- 17 Sep 2021 (actual)
- First posted
- 3 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EverVita Pro consumed at breakfast followed by an ad lib meal | Experimental | Other: EverVita ProBefore 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. |
| Control consumed at breakfast followed by an ad lib meal. | Placebo comparator | Other: Control breadBefore 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. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EverVita ProEverVita Pro is composed of barley and corn, grown and mechanically processed in Europe, with non-GMO grains. | Other | EverVita Pro consumed at breakfast followed by an ad lib meal |
| Control breadBread baked with normal Bakers flour | Other | Control consumed at breakfast followed by an ad lib meal. |
Primary outcome
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.
3 secondary outcomes
Satiety scores from VAS per individual
Time frame: every 10 minutes for 90 minutes, then after 120 minutes again
Satiety scores from VAS between individuals
Time frame: every 10 minutes for 90 minutes, then after 120 minutes again
Gastrointestinal effects via GI symptoms questionnaire
Time frame: at t=0, after 90 minutes, before bed time and 24 hours after start intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2022.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Wolever, DM, PhD principal investigator
INQUIS Clinical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EverVita Pro in people with Satiety of High Fiber High Protein Bread, run by Evergrain, LLC at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Energy intake comparison (time frame: at time point 1.5 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2022.