Clinical trial NCT05130593: Pilot Study Evaluating the Acceptability and Absorption of the Bioactive Compounds of a Russian Tarragon Nutrasorb Bar
Official title: Pilot Study Evaluating the Hedonic Acceptability and Absorption of the Bioactive Compounds of a 5011-Nutrasorb Bar (Russian Tarragon Nutrasorb)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Prevention
Keywords: tarragon
Lead sponsor: Pennington Biomedical Research Center
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
name: Office of Dietary Supplements (ODS)
First posted: 2021-11-23
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: healthy males and females aged 18-50 with a body mass index between 20-30 kg/m2

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.

Eligibility criteria: Inclusion Criteria:

* Healthy males or females between 18 and 50 years of age inclusive.
* Body mass index between 20-30 kg/m2.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Palatability of Bar
timeFrame: Test Day (immediately after taste-testing the bar)
Secondary outcomes:
measure: Levels of Plasma BIoactive (DMC-2) Before and After Ingestion of a Bar Containing PMI-5011/Nutrasorb.
timeFrame: 10 minutes pre-consumption, immediately post-consumption, and 30, 60, 120, and 180 minutes post-consumption
measure: Levels of Serum Glucose Before and After Ingestion of a Bar Containing PMI-5011/Nutrasorb.
timeFrame: 10 minutes pre-consumption, immediately post-consumption, and 30, 60, 120, and 180 minutes post-consumption
measure: Measurement of Blood Levels of Serum Insulin Before and After Ingestion of a Bar Containing PMI-5011/Nutrasorb.
timeFrame: 10 minutes pre-consumption, immediately post-consumption, and 30, 60, 120, and 180 minutes post-consumption
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
Study officials:
affiliation: Pennington Biomedical Research Center
name: Jennifer C Rood, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: