Food AcceptancePOLYPRONCT07489118
Impact of Protein Source and Polyphenol Complexation in Protein Bars on Metabolic Health
A study testing Whey protein bar, Pea protein bar and Pea protein with complexed polyphenols bar in people with Food Acceptance and Metabolic Health, run by North Carolina State University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Food Acceptance, Metabolic Health, Immune Cells Activity
- What is being tested?
- Whey protein bar, Pea protein bar and Pea protein with complexed polyphenols bar
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2025to 1 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Plants for Human Health Institute
Kannapolis, North Carolina, 28081
About this study
Official title: Impact of Consuming Protein and Polyphenol Bars on Metabolic Health
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.
- Being tested
- Whey protein bar, Pea protein bar, Pea protein with complexed polyphenols bar, Pea protein with free polyphenols bar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whey protein barOther
Whey protein bar
Pea protein barOther
Pea protein bar
Pea protein with complexed polyphenols barOther
Pea protein with complexed polyphenols bar
Pea protein with free polyphenols barOther
Pea protein with free polyphenols bar
| Study group | Role | What they receive |
|---|---|---|
| Whey protein bar | Active comparator | Whey protein bar Receives: Other: Whey protein bar |
| Pea protein bar | Experimental | Pea protein bar Receives: Other: Pea protein bar |
| Pea protein complexed with polyphenols bar | Experimental | Pea proteins and complexed with blackcurrant polyphenols as a single ingredient Receives: Other: Pea protein with complexed polyphenols bar |
| Pea protein with free polyphenols | Experimental | Pea proteins and blackcurrant polyphenols are two independent ingredients Receives: Other: Pea protein with free polyphenols bar |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: At baseline and after 2 months (end of study)
Secondary outcomes (7)
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).
Measured: At baseline and after 2 months (end of study)
Fasting insulin
Blood
Measured: At baseline and after 2 months (end of study)
Fasting glucose
Blood
Measured: At baseline and after 2 months (end of study)
Glycosylated HbA1C
Blood
Measured: At baseline and after 2 months (end of study)
triglycerides
Blood
Measured: At baseline and after 2 months (end of study)
Cholesterol
Blood
Measured: 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.
Measured: At baseline and after 2 months (end of study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2026
- Study start1 May 2025
- Primary completion8 Sep 2025
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Food AcceptanceStudies 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- North Carolina State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Slavko Komarnytsky, North Carolina State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07489118
- Sponsor's protocol ID
- 26377
- Other IDs
- 58-3060-1-043
- Acronym
- POLYPRO
- Status last verified
- Feb 2026
- First submitted
- 5 Mar 2026
- Last updated
- 23 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
https://doi.org/10.1111/jfpe.70121
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Consuming Protein and Polyphenol Bars on Metabolic Health
- ClinicalTrials.gov ID
- NCT07489118
- Acronym / sponsor ID
- POLYPRO / 26377
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 72 participants (actual)
- Lead sponsor
- North Carolina State UniversityUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 8 Sep 2025 (actual)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 23 Mar 2026 (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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Whey protein bar | Active comparator | Other: Whey protein barWhey protein bar |
| Pea protein bar | Experimental | Other: Pea protein barPea protein bar |
| Pea protein complexed with polyphenols bar | Experimental | Other: Pea protein with complexed polyphenols barPea proteins and complexed with blackcurrant polyphenols as a single ingredient |
| Pea protein with free polyphenols | Experimental | Other: Pea protein with free polyphenols barPea proteins and blackcurrant polyphenols are two independent ingredients |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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;
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 |
|---|---|---|
| Whey protein barWhey protein bar | Other | Whey protein bar |
| Pea protein barPea protein bar | Other | Pea protein bar |
| Pea protein with complexed polyphenols barPea protein with complexed polyphenols bar | Other | Pea protein complexed with polyphenols bar |
| Pea protein with free polyphenols barPea protein with free polyphenols bar | Other | Pea protein with free polyphenols |
Primary outcome
Taste
Time frame: 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
Time frame: 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)
7 secondary outcomes
Perceived health
Time frame: At baseline and after 2 months (end of study)
Fasting insulin
Time frame: At baseline and after 2 months (end of study)
Fasting glucose
Time frame: At baseline and after 2 months (end of study)
Glycosylated HbA1C
Time frame: At baseline and after 2 months (end of study)
triglycerides
Time frame: At baseline and after 2 months (end of study)
Cholesterol
Time frame: At baseline and after 2 months (end of study)
Homeostatic Model Assessment of Insulin Resistance
Time frame: At baseline and after 2 months (end of study)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
- Backgroundhttps://doi.org/10.1111/jfpe.70121
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whey protein bar, Pea protein bar and Pea protein with complexed polyphenols bar in people with Food Acceptance and Metabolic Health, run by North Carolina State University at 1 site in United States.
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 6 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 23 Mar 2026. 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 United States. 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. 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?
This study is still under way. Results are not available in the source record yet.
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?
Taste (time frame: At baseline and after 2 months (end of study)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07489118, which also lists 1 linked publication.
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 23 Mar 2026.