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

Diabetes Prevention Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05130593
• Other study ID #: PBRC 2020-022
• Secondary ID: 5P50AT002776-15
• Status: Completed
• Start date: October 25, 2021
• Est. completion date: October 31, 2022

Study information

• Verified date: November 2023
• Source: Pennington Biomedical Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 31, 2022
• Est. primary completion date: October 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Prevention

Intervention

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

Locations

Country	Name	City	State
United States	Pennington Biomedical Research Center	Baton Rouge	Louisiana

Sponsors (3)

Lead Sponsor	Collaborator
Pennington Biomedical Research Center	National Center for Complementary and Integrative Health (NCCIH), Office of Dietary Supplements (ODS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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