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

NCT04869215 | Completed

• 1 other identifier: Satiety EVP in bread
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Satiety of High Fiber High Protein Bread

Keywords

satiation, fullness, protein, fiber, hunger, bread

Outcome Measures

Primary Outcomes (1)

• Energy intake comparison

  Compare energy intake from the ad libitum pizza meal following the EverVita Pro containing meal and a control meal.

  at time point 1.5 hours

Secondary Outcomes (3)

• Satiety scores from VAS per individual

  every 10 minutes for 90 minutes, then after 120 minutes again

• Satiety scores from VAS between individuals

  every 10 minutes for 90 minutes, then after 120 minutes again

• Gastrointestinal effects via GI symptoms questionnaire

  at t=0, after 90 minutes, before bed time and 24 hours after start intervention

Study Arms (2)

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.

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.

Other: Control bread

Interventions

EverVita Pro OTHER

EverVita Pro is composed of barley and corn, grown and mechanically processed in Europe, with non-GMO grains.

EverVita Pro consumed at breakfast followed by an ad lib meal

Control bread OTHER

Bread baked with normal Bakers flour

Control consumed at breakfast followed by an ad lib meal.

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Evergrain, LLC: lead
• INQUIS Clinical Research: collaborator

Study Sites (1)

INQUIS Clinical Research

Toronto, Ontario, M5C2N8, Canada

Location

Study Officials

• Thomas Wolever, DM, PhD

  INQUIS Clinical Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2021
• First Posted: May 3, 2021
• Study Start: June 22, 2021
• Primary Completion: September 17, 2021
• Study Completion: September 17, 2021
• Last Updated: July 28, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)