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| ID | Type | Description | Link |
|---|---|---|---|
| 58-3060-1-043 | Other Grant/Funding Number | USDA ARS Pulse Crop Health Initiative |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Whey protein bar | Active Comparator | Whey protein bar |
|
| Pea protein bar | Experimental | Pea protein bar |
|
| Pea protein complexed with polyphenols bar | Experimental | Pea proteins and complexed with blackcurrant polyphenols as a single ingredient |
|
| Pea protein with free polyphenols | Experimental | Pea proteins and blackcurrant polyphenols are two independent ingredients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Whey protein bar | Other | Whey protein bar |
| |
| Pea protein bar |
| Measure | Description | Time Frame |
|---|---|---|
| Taste | 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) | At baseline and after 2 months (end of study) |
| Gastrointestinal tolerance | 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) | At baseline and after 2 months (end of study) |
| Measure | Description | Time Frame |
|---|---|---|
| Perceived health | 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). | At baseline and after 2 months (end of study) |
| Measure | Description | Time Frame |
|---|---|---|
| Immune activation of PMBC cells | Global PMBC transcriptome analysis (DGE RNA-Seq) | At baseline and after 2 months (end of study) |
| Gastrointestinal microbiome profiles | Changes in fecal microbiome profiles |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Plants for Human Health Institute | Kannapolis | North Carolina | 28081 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | https://doi.org/10.1111/jfpe.70121 |
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| Other |
Pea protein bar |
|
| Pea protein with complexed polyphenols bar | Other | Pea protein with complexed polyphenols bar |
|
| Pea protein with free polyphenols bar | Other | Pea protein with free polyphenols bar |
|
| Fasting insulin |
Blood |
| At baseline and after 2 months (end of study) |
| Fasting glucose | Blood | At baseline and after 2 months (end of study) |
| Glycosylated HbA1C | Blood | At baseline and after 2 months (end of study) |
| triglycerides | Blood | At baseline and after 2 months (end of study) |
| Cholesterol | Blood | At baseline and after 2 months (end of study) |
| Homeostatic Model Assessment of Insulin Resistance | 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. | At baseline and after 2 months (end of study) |
| At baseline and after 2 months (end of study) |
| ID | Term |
|---|---|
| D000078724 | Pea Proteins |
| ID | Term |
|---|---|
| D014674 | Plant Proteins, Dietary |
| D004044 | Dietary Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D010940 | Plant Proteins |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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