N/A
Completed N=20
Pilot Study Evaluating the Acceptability and Absorption of the Bioactive Compounds of a Russian Tarragon Nutrasorb Bar
Diabetes Prevention
Source: ClinicalTrials.gov NCT05130593 ↗
Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Nov 2023
Primary outcomePrimary: Palatability of Bar — 77.4; 59.5; 27.8; 50.6 score on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Palatability of Bar |
77.4; 59.5; 27.8; 50.6; 56.5; 32.2 | — |
| SECONDARY Levels of Plasma BIoactive (DMC-2) Before and After Ingestion of a Bar Containing PMI-5011/Nutrasorb. |
0.05; 0.05; 0.094; 0.076; 0.087; 0.074 | — |
| SECONDARY Levels of Serum Glucose Before and After Ingestion of a Bar Containing PMI-5011/Nutrasorb. |
88; 89; 91; 91; 90; 89 | — |
| SECONDARY Measurement of Blood Levels of Serum Insulin Before and After Ingestion of a Bar Containing PMI-5011/Nutrasorb. |
9.6; 10.4; 30.7; 25.8; 14.3; 7.2 | — |
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.
Data sourced from ClinicalTrials.gov (NCT05130593). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.