Diabetes Prevention
Conditions
Keywords
tarragon
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.
Interventions
DIETARY_SUPPLEMENTNutrasorb bar
250 kcal bar containing 30 g of 5011-Nutrasorb (120 kcal), 20 g fat (100 kcal), and 30 kcal from carbohydrate and flavorings
Sponsors
National Center for Complementary and Integrative Health (NCCIH)
Office of Dietary Supplements (ODS)
Pennington Biomedical Research Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Palatability of Bar | Test Day (immediately after taste-testing the 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 |
| 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 | 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 |
| 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 | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Phase 1 Participants taste-tested a bar containing PMI-5011/Nutrasorb for acceptability. 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 |
| Phase 2 Participants consumed a bar containing PMI-5011/Nutrasorb and had blood samples drawn for measurement of safety parameters (glucose and insulin) and bioactive compounds (DMC-2). 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 |
| Total | 20 |
Baseline characteristics
| Characteristic | Phase 1 | Phase 2 | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants | 10 Participants | 20 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 10 Participants | 9 Participants | 19 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 7 Participants | 10 Participants | 17 Participants |
| Region of Enrollment United States | 10 participants | 10 participants | 20 participants |
| Sex: Female, Male Female | 6 Participants | 5 Participants | 11 Participants |
| Sex: Female, Male Male | 4 Participants | 5 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 0 / 10 | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 |
Outcome results
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.
Time frame: Test Day (immediately after taste-testing the bar)
Population: Only the participants in Phase 1 of the study participated in taste-testing of the bar for palatability. Participants from Phase 1 were not allowed to participate in Phase 2.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 1 | Palatability of Bar | Visual Appearance | 77.4 score on a scale | Standard Deviation 19.7 |
| Phase 1 | Palatability of Bar | Smell | 59.5 score on a scale | Standard Deviation 19.2 |
| Phase 1 | Palatability of Bar | Taste | 27.8 score on a scale | Standard Deviation 24.4 |
| Phase 1 | Palatability of Bar | Texture | 50.6 score on a scale | Standard Deviation 20.8 |
| Phase 1 | Palatability of Bar | Aftertaste | 56.5 score on a scale | Standard Deviation 31.4 |
| Phase 1 | Palatability of Bar | Pleasantness | 32.2 score on a scale | Standard Deviation 25.6 |
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
Time frame: 10 minutes pre-consumption, immediately post-consumption, and 30, 60, 120, and 180 minutes post-consumption
Population: Only the participants in Phase 2 of the study had blood samples drawn for measurement of bioactive compounds (DMC-2). Participants from Phase 1 were not allowed to participate in Phase 2.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 1 | Levels of Plasma BIoactive (DMC-2) Before and After Ingestion of a Bar Containing PMI-5011/Nutrasorb. | - 10 min | 0.05 ug/mL | Standard Deviation 0 |
| Phase 1 | Levels of Plasma BIoactive (DMC-2) Before and After Ingestion of a Bar Containing PMI-5011/Nutrasorb. | 0 min | 0.05 ug/mL | Standard Deviation 0 |
| Phase 1 | Levels of Plasma BIoactive (DMC-2) Before and After Ingestion of a Bar Containing PMI-5011/Nutrasorb. | 30 min | 0.094 ug/mL | Standard Deviation 0.026 |
| Phase 1 | Levels of Plasma BIoactive (DMC-2) Before and After Ingestion of a Bar Containing PMI-5011/Nutrasorb. | 60 min | 0.076 ug/mL | Standard Deviation 0.022 |
| Phase 1 | Levels of Plasma BIoactive (DMC-2) Before and After Ingestion of a Bar Containing PMI-5011/Nutrasorb. | 120 min | 0.087 ug/mL | Standard Deviation 0.026 |
| Phase 1 | Levels of Plasma BIoactive (DMC-2) Before and After Ingestion of a Bar Containing PMI-5011/Nutrasorb. | 180 min | 0.074 ug/mL | Standard Deviation 0.013 |
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
Time frame: 10 minutes pre-consumption, immediately post-consumption, and 30, 60, 120, and 180 minutes post-consumption
Population: Only the participants in Phase 2 of the study had blood samples drawn for measurement of serum glucose. Participants from Phase 1 were not allowed to participate in Phase 2.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 1 | Levels of Serum Glucose Before and After Ingestion of a Bar Containing PMI-5011/Nutrasorb. | -10 min | 88 mg/dL | Standard Deviation 6.2 |
| Phase 1 | Levels of Serum Glucose Before and After Ingestion of a Bar Containing PMI-5011/Nutrasorb. | 0 min | 89 mg/dL | Standard Deviation 5.5 |
| Phase 1 | Levels of Serum Glucose Before and After Ingestion of a Bar Containing PMI-5011/Nutrasorb. | 30 min | 91 mg/dL | Standard Deviation 6.9 |
| Phase 1 | Levels of Serum Glucose Before and After Ingestion of a Bar Containing PMI-5011/Nutrasorb. | 60 min | 91 mg/dL | Standard Deviation 5.5 |
| Phase 1 | Levels of Serum Glucose Before and After Ingestion of a Bar Containing PMI-5011/Nutrasorb. | 120 min | 90 mg/dL | Standard Deviation 4.7 |
| Phase 1 | Levels of Serum Glucose Before and After Ingestion of a Bar Containing PMI-5011/Nutrasorb. | 180 min | 89 mg/dL | Standard Deviation 5.1 |
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
Time frame: 10 minutes pre-consumption, immediately post-consumption, and 30, 60, 120, and 180 minutes post-consumption
Population: Only the participants in Phase 2 of the study had blood samples drawn for measurement of insulin. Participants from Phase 1 were not allowed to participate in Phase 2.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 1 | Measurement of Blood Levels of Serum Insulin Before and After Ingestion of a Bar Containing PMI-5011/Nutrasorb. | -10 min | 9.6 uIU/mL | Standard Deviation 12.8 |
| Phase 1 | Measurement of Blood Levels of Serum Insulin Before and After Ingestion of a Bar Containing PMI-5011/Nutrasorb. | 0 min | 10.4 uIU/mL | Standard Deviation 13.9 |
| Phase 1 | Measurement of Blood Levels of Serum Insulin Before and After Ingestion of a Bar Containing PMI-5011/Nutrasorb. | 30 min | 30.7 uIU/mL | Standard Deviation 30.5 |
| Phase 1 | Measurement of Blood Levels of Serum Insulin Before and After Ingestion of a Bar Containing PMI-5011/Nutrasorb. | 60 min | 25.8 uIU/mL | Standard Deviation 31.4 |
| Phase 1 | Measurement of Blood Levels of Serum Insulin Before and After Ingestion of a Bar Containing PMI-5011/Nutrasorb. | 120 min | 14.3 uIU/mL | Standard Deviation 16.7 |
| Phase 1 | Measurement of Blood Levels of Serum Insulin Before and After Ingestion of a Bar Containing PMI-5011/Nutrasorb. | 180 min | 7.2 uIU/mL | Standard Deviation 6.4 |