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Active, Not Recruiting

NCT Number: NCT07489118

Impact of Protein Source and Polyphenol Complexation in Protein 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Food Acceptance Immune Cells Activity Metabolic Health Microbiome Composition

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Plants for Human Health Institute

Kannapolis, North Carolina, 28081, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Whey protein bar

Other

Whey protein bar

Pea protein bar

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

Primary outcomes

  1. 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)

  2. 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)

Secondary outcomes

  1. Perceived health

    Time frame: 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).

  2. Fasting insulin

    Time frame: At baseline and after 2 months (end of study)

    Blood

  3. Fasting glucose

    Time frame: At baseline and after 2 months (end of study)

    Blood

  4. Glycosylated HbA1C

    Time frame: At baseline and after 2 months (end of study)

    Blood

  5. triglycerides

    Time frame: At baseline and after 2 months (end of study)

    Blood

  6. Cholesterol

    Time frame: At baseline and after 2 months (end of study)

    Blood

  7. Homeostatic Model Assessment of Insulin Resistance

    Time frame: 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.

Other outcomes

  1. Immune activation of PMBC cells

    Time frame: At baseline and after 2 months (end of study)

    Global PMBC transcriptome analysis (DGE RNA-Seq)

  2. Gastrointestinal microbiome profiles

    Time frame: At baseline and after 2 months (end of study)

    Changes in fecal microbiome profiles

Sponsors and collaborators

Lead sponsor

North Carolina State University

Other

Registry information

Official study title

Impact of Consuming Protein and Polyphenol Bars on Metabolic Health

Acronym: POLYPRO

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Mar 23, 2026
Registry last updated
Mar 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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