Impact of Protein Source and Polyphenol Complexation in Protein Bars on Metabolic Health

NCT07489118 | Active Not Recruiting

• 2 other identifiers: 2637758-3060-1-043
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Immune Cells Activity; Food Acceptance; Metabolic Health; Microbiome Composition

Outcome Measures

Primary Outcomes (2)

• 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)

Secondary Outcomes (7)

• Perceived health

  At baseline and after 2 months (end of study)

• Fasting insulin

  At baseline and after 2 months (end of study)

• Fasting glucose

  At baseline and after 2 months (end of study)

• Glycosylated HbA1C

  At baseline and after 2 months (end of study)

• triglycerides

  At baseline and after 2 months (end of study)

Other Outcomes (2)

• Immune activation of PMBC cells

  At baseline and after 2 months (end of study)

• Gastrointestinal microbiome profiles

  At baseline and after 2 months (end of study)

Study Arms (4)

Whey protein bar

ACTIVE COMPARATOR

Whey protein bar

Other: Whey protein bar

Pea protein bar

EXPERIMENTAL

Pea protein bar

Other: Pea protein bar

Pea protein complexed with polyphenols bar

EXPERIMENTAL

Pea proteins and complexed with blackcurrant polyphenols as a single ingredient

Other: Pea protein with complexed polyphenols bar

Pea protein with free polyphenols

EXPERIMENTAL

Pea proteins and blackcurrant polyphenols are two independent ingredients

Other: Pea protein with free polyphenols bar

Interventions

Whey protein bar OTHER

Whey protein bar

Whey protein bar

Pea protein bar OTHER

Pea protein bar

Pea protein bar

Pea protein with complexed polyphenols bar OTHER

Pea protein with complexed polyphenols bar

Pea protein complexed with polyphenols bar

Pea protein with free polyphenols bar OTHER

Pea protein with free polyphenols bar

Pea protein with free polyphenols

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• North Carolina State University: lead

Study Sites (1)

Plants for Human Health Institute

Kannapolis, North Carolina, 28081, United States

Location

Related Publications (1)

• https://doi.org/10.1111/jfpe.70121

  BACKGROUND

MeSH Terms

Interventions

Pea Proteins

Intervention Hierarchy (Ancestors)

Plant Proteins, Dietary; Dietary Proteins; Proteins; Amino Acids, Peptides, and Proteins; Plant Proteins; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Pharmacogenomics

Study Record Dates

• First Submitted: March 5, 2026
• First Posted: March 23, 2026
• Study Start: May 1, 2025
• Primary Completion: September 8, 2025
• Study Completion: April 1, 2026
• Last Updated: March 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)