Pilot Study Evaluating the Acceptability and Absorption of the Bioactive Compounds of a Russian Tarragon Nutrasorb Bar

Pilot Study Evaluating the Hedonic Acceptability and Absorption of the Bioactive Compounds of a 5011-Nutrasorb Bar (Russian Tarragon Nutrasorb)

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Prevention
• Intervention / Treatment: Dietary supplement: Nutrasorb bar

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.

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• United States
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70808
      • Pennington Biomedical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

healthy males and females aged 18-50 with a body mass index between 20-30 kg/m2

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Nutrasorb bar evaluation; Participants in Phase 1 will taste test the bar for acceptability. Participants in Phase 2 will consume the bar and have blood samples drawn for measurement of safety parameters (glucose and insulin) and bioactive compounds (DMC-2).	Dietary supplement: Nutrasorb bar; 250 kcal bar containing 30 g of 5011-Nutrasorb (120 kcal), 20 g fat (100 kcal), and 30 kcal from carbohydrate and flavorings

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Palatability of 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.	Test Day (immediately after taste-testing the bar)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Levels of Plasma BIoactive (DMC-2) Before and After Ingestion of a Bar Containing PMI-5011/Nutrasorb.	Participants consumed a bar containing PMI-5011 and Nutrasorb and had blood samples drawn for measurement of DMC-2. Nutrasorb bar: 250 kcal bar containing 30 g of PMI-5011/Nutrasorb (120 kcal), 20 g fat (100 kcal), and 30 kcal from carbohydrate and flavorings	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.	Participants consumed a bar containing PMI-5011 and Nutrasorb and had blood samples drawn for measurement of safety parameters (glucose). Nutrasorb bar: 250 kcal bar containing 30 g of 5011-Nutrasorb (120 kcal), 20 g fat (100 kcal), and 30 kcal from carbohydrate and flavorings	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.	Participants consumed a bar containing PMI-5011 and Nutrasorb and had blood samples drawn for measurement of safety parameters (insulin). Nutrasorb bar: 250 kcal bar containing 30 g of 5011-Nutrasorb (120 kcal), 20 g fat (100 kcal), and 30 kcal from carbohydrate and flavorings	10 minutes pre-consumption, immediately post-consumption, and 30, 60, 120, and 180 minutes post-consumption

Collaborators and Investigators

• Sponsor: Pennington Biomedical Research Center
• Collaborators: National Center for Complementary and Integrative Health (NCCIH); Office of Dietary Supplements (ODS)
• Investigators: Principal Investigator: Jennifer C Rood, Ph.D., Pennington Biomedical Research Center

Study record dates

Study Major Dates

• Study Start (Actual): October 25, 2021
• Primary Completion (Actual): October 31, 2022
• Study Completion (Actual): October 31, 2022

Study Registration Dates

• First Submitted: October 6, 2021
• First Submitted That Met QC Criteria: November 10, 2021
• First Posted (Actual): November 23, 2021

Study Record Updates

• Last Update Posted (Estimated): November 16, 2023
• Last Update Submitted That Met QC Criteria: November 14, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: tarragon
• Other Study ID Numbers: PBRC 2020-022; 5P50AT002776-15 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No