Food Acceptance, Immune Cells Activity, Metabolic Health, Microbiome Composition
Conditions
Brief summary
The goal of this clinical trial is to learn if pulse (pea) protein works similar to animal (whey) protein in protein bars consumed by healthy adults. The main questions it aims to answer are: What are the differences in taste and tolerance profiles between pea and whey proteins? What metabolic and immune changes do participants experience while eating them? What gastrointestinal microbiome shifts can be observed in these participants? How incorporation and complexation of polyphenols with these proteins changes the study outcomes? Participants will: Consume 1 protein bar with whey protein, pea protein, pea protein with complexed polyphenols, or pea protein with free polyphenols every day for 2 months. Visit the study site at baseline and end of study for checkups and tests. Fill dietary, food acceptance, gastrointestinal tolerance, and global health questionnaires.
Interventions
OTHERWhey protein bar
Whey protein bar
OTHERPea protein bar
Pea protein bar
OTHERPea protein with complexed polyphenols bar
Pea protein with complexed polyphenols bar
OTHERPea protein with free polyphenols bar
Pea protein with free polyphenols bar
Sponsors
North Carolina State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
Yes
Inclusion criteria
* both men and women between the ages of 18-64 years; * body mass index of 25 and higher; * generally healthy and without a clinically significant condition (diabetes, infectious disease, or cancer); * participants must not be pregnant or nursing; * participants must not be a tobacco user; and * history of allergies or intolerance to protein bar ingredients.
Exclusion criteria
* body mass index lower than 25; * pregnancy or nursing; * use of blood sugar lowering medications such as metformin, semaglutide, or insulin; * use of dietary supplements with polyphenols; * history of allergies or intolerance to protein bar ingredients; * noncompliance with the study protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Taste | At baseline and after 2 months (end of study) | Participants will report taste of the protein bars using a 9-point hedonic scale scored from 1 (dislike extremely) to 9 (like extremely) in a Food Acceptance Questionnaire (FAQ) |
| Gastrointestinal tolerance | At baseline and after 2 months (end of study) | Gastrointestinal tolerance will be assessed using the Gastrointestinal Tolerability Questionnaire (GTQ) scored on the scale of 0 (absent), 1 (mild), 2 (moderate), or 3 (severe) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Perceived health | At baseline and after 2 months (end of study) | Overall perceived health will be monitored using self-reported wellness status as determined by PROMIS Global-10 questionnaire scored into a physical and mental health components on the scale of 1 (poor), 2 (fair), 3 (good), 4 (very good), or 5 (excellent). |
| Fasting insulin | At baseline and after 2 months (end of study) | Blood |
| Fasting glucose | At baseline and after 2 months (end of study) | Blood |
| Glycosylated HbA1C | At baseline and after 2 months (end of study) | Blood |
| triglycerides | At baseline and after 2 months (end of study) | Blood |
| Cholesterol | At baseline and after 2 months (end of study) | Blood |
| Homeostatic Model Assessment of Insulin Resistance | At baseline and after 2 months (end of study) | The Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) will be calculated using fasting glucose (FG) and fasting insulin (FI) levels to evaluate insulin sensitivity as (FG×FI)/22.5. |
Countries
United States
Outcome results
None listed