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

N/AActive Not RecruitingNCT07489118

North Carolina State University72 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Enrollment

Conditions

Food Acceptance Metabolic Health Immune Cells Activity

Eligibility

Sex: ALLMin age: 18 YearsMax age: 64 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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)