Ignite Creation Date:
2025-12-25 @ 1:14 AM
Ignite Modification Date:
2026-01-02 @ 2:03 PM
Study NCT ID:
NCT05130593
Status:
COMPLETED
Last Update Posted:
2023-11-18
First Post:
2021-10-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Pilot Study Evaluating the Acceptability and Absorption of the Bioactive Compounds of a Russian Tarragon Nutrasorb Bar
Sponsor:
Pennington Biomedical Research Center
Organization:
Study Overview
Official Title:
Pilot Study Evaluating the Hedonic Acceptability and Absorption of the Bioactive Compounds of a 5011-Nutrasorb Bar (Russian Tarragon Nutrasorb)
Status:
COMPLETED
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
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.
Phase 2
Screening Visit: Fasting Visit (nothing to eat or drink other than water after 10 pm the night before the Screening Visit); visit will be approximately 1 ½ hours.
The following procedures will be done on the Screening Visit:
* 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).
* Blood pressure and pulse will be measured.
* Medical history questionnaire will be completed.
* Blood will be drawn (approximately 2 teaspoons) to assess overall health.
Test Day: Fasting visit (nothing to eat or drink other than water after 10 pm the night before the Test Day); visit will be approximately 4 hours and will be completed within 30 days after Screening Visit.
The following procedures will be done on the Test Day:
* Blood will be drawn from an IV line placed in the participant's arm to assess the level of nutrients, blood sugar levels, and insulin levels from the study bar 10 minutes before the bar is consumed, immediately after the bar is consumed, and 30, 60, 120, and 180 minutes after the bar is consumed. A total of approximately 6 teaspoons of blood will be drawn for this Test Day.
* Participants will answer questions regarding the appearance, smell, taste, texture, aftertaste, and pleasantness of the bar.
* Participants will be asked about any side effects and how they feel throughout the Test Day.
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.
Phase 2
Screening Visit: Fasting Visit (nothing to eat or drink other than water after 10 pm the night before the Screening Visit); visit will be approximately 1 ½ hours.
The following procedures will be done on the Screening Visit:
* 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).
* Blood pressure and pulse will be measured.
* Medical history questionnaire will be completed.
* Blood will be drawn (approximately 2 teaspoons) to assess overall health.
Test Day: Fasting visit (nothing to eat or drink other than water after 10 pm the night before the Test Day); visit will be approximately 4 hours and will be completed within 30 days after Screening Visit.
The following procedures will be done on the Test Day:
* Blood will be drawn from an IV line placed in the participant's arm to assess the level of nutrients, blood sugar levels, and insulin levels from the study bar 10 minutes before the bar is consumed, immediately after the bar is consumed, and 30, 60, 120, and 180 minutes after the bar is consumed. A total of approximately 6 teaspoons of blood will be drawn for this Test Day.
* Participants will answer questions regarding the appearance, smell, taste, texture, aftertaste, and pleasantness of the bar.
* Participants will be asked about any side effects and how they feel throughout the Test Day.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 5P50AT002776-15 | NIH | None | https://reporter.nih.gov/quic… | View |