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

NCT05130593 | Completed Results

• 2 other identifiers: PBRC 2020-0225P50AT002776-15
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Prevention

Keywords

tarragon

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (1)

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

Interventions

Nutrasorb bar DIETARY_SUPPLEMENT

250 kcal bar containing 30 g of 5011-Nutrasorb (120 kcal), 20 g fat (100 kcal), and 30 kcal from carbohydrate and flavorings

Nutrasorb bar evaluation

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pennington Biomedical Research Center: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator
• Office of Dietary Supplements (ODS): collaborator

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

Results Point of Contact

• Title: Jennifer C Rood, PhD
• Organization: Pennington Biomedical Research Center

jennifer.rood@pbrc.edu

225-763-2524

Study Officials

• Jennifer C Rood, Ph.D.

  Pennington Biomedical Research Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 6, 2021
• First Posted: November 23, 2021
• Study Start: October 25, 2021
• Primary Completion: October 31, 2022
• Study Completion: October 31, 2022
• Last Updated: November 18, 2023
• Results First Posted: November 18, 2023

Record last verified: 2023-11

Locations

US (1)