Impact of Consuming Protein and Polyphenol Bars on Metabolic Health
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Taste
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Taste
时间窗: 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
时间窗: 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)
次要结局
- 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))
- Cholesterol(At baseline and after 2 months (end of study))
- Homeostatic Model Assessment of Insulin Resistance(At baseline and after 2 months (end of study))
研究者
Slavko Komarnytsky
Associate Professor, Pharmacogenomics
North Carolina State University