Status:
COMPLETED
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
Lead Sponsor:
Evergrain, LLC
Collaborating Sponsors:
INQUIS Clinical Research
Conditions:
Satiety of High Fiber High Protein Bread
Eligibility:
All Genders
20-70 years
Phase:
NA
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, bu...
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 port...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 22 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 17 2021
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04869215
Start Date
June 22 2021
End Date
September 17 2021
Last Update
July 28 2022
Active Locations (1)
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1
INQUIS Clinical Research
Toronto, Ontario, Canada, M5C2N8