Pilot Study Evaluating the Hedonic Acceptability and Absorption of the Bioactive Compounds of a 5011-Nutrasorb Bar (Russian Tarragon Nutrasorb)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Palatability of Bar
研究概览
简要总结
The purpose of this study is to make a bar from the soy-protein Russian Tarragon complex (PMI-5011/Nutrasorb) that is safe and acceptable for consumption, and to test the blood levels of plasma bioactive (DMC-2) after ingestion of the bar. The PMI-5011/Nutrasorb comes from a plant source called Artemisia dracunculus. This plant has a long history of medicinal (health) and culinary (food) use and has been reported as effective as a traditional treatment for diabetes in various parts of the world.
详细描述
Phase 1
Test Day: Fasting Visit (nothing to eat or drink other than water beginning at 10 pm the night before the test day); visit will be approximately 1 ½ hours.
The following procedures will be done on the Test Day:
- Informed consent will be signed by those agreeing to participate.
- Body weight and height will be measured (body mass index will be calculated from these measures).
- Participants will provide a list of any medications they are currently taking.
- Blood pressure and pulse will be measured.
- Taste test of the study bar will be conducted.
- Participants will answer questions regarding the appearance, smell, taste, texture, aftertaste, and pleasantness of the bar.
Phase 1 participants may be asked to return up to two additional times to complete the taste test and questions again. This will occur if the product is found unacceptable and will be completed after a new bar is produced.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy males or females between 18 and 50 years of age inclusive.
- •Body mass index between 20-30 kg/m2.
排除标准
- •Pregnant or currently lactating.
- •Taking any prescription medications.
- •Taking any over-the-counter medications that cannot be stopped for test days.
- •Allergic to any ingredients contained in the bar.
- •Other conditions or situations that would interfere with the study or the participant's safety as determined by the investigators.
- •Participants in Phase 1 of the study may not participate in Phase 2 of the study.
结局指标
主要结局
Palatability of Bar
时间窗: Test Day (immediately after taste-testing the bar)
Participants were asked to rate the bar on a visual analog scale to indicate their impression of its visual appearance, smell, taste, texture, aftertaste, and overall pleasantness. The scale range for each attribute is 0-100 with higher scores equating to a better outcome.
次要结局
- Levels of Plasma BIoactive (DMC-2) Before and After Ingestion of a Bar Containing PMI-5011/Nutrasorb.(10 minutes pre-consumption, immediately post-consumption, and 30, 60, 120, and 180 minutes post-consumption)
- Levels of Serum Glucose Before and After Ingestion of a Bar Containing PMI-5011/Nutrasorb.(10 minutes pre-consumption, immediately post-consumption, and 30, 60, 120, and 180 minutes post-consumption)
- Measurement of Blood Levels of Serum Insulin Before and After Ingestion of a Bar Containing PMI-5011/Nutrasorb.(10 minutes pre-consumption, immediately post-consumption, and 30, 60, 120, and 180 minutes post-consumption)
研究者
Jennifer C. Rood
Principal Investigator
Pennington Biomedical Research Center