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| ID | Type | Description | Link |
|---|---|---|---|
| 5P50AT002776-15 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
| Office of Dietary Supplements (ODS) | NIH |
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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.
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:
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:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| 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) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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healthy males and females aged 18-50 with a body mass index between 20-30 kg/m2
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer C Rood, Ph.D. | Pennington Biomedical Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pennington Biomedical Research Center | Baton Rouge | Louisiana | 70808 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Phase 2 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Test Day (immediately after taste-testing the bar) |
|
Test Day (up to 4 hours)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jennifer C Rood, PhD | Pennington Biomedical Research Center | 225-763-2524 | jennifer.rood@pbrc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 14, 2020 | Nov 1, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 14, 2020 | Nov 1, 2022 | ICF_001.pdf |
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| 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 |
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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units | Counts |
|---|---|
| Participants |
|
|
| 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 | 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. | Posted | Mean | Standard Deviation | ug/mL | 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 | 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. | Posted | Mean | Standard Deviation | mg/dL | 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 | 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. | Posted | Mean | Standard Deviation | uIU/mL | 10 minutes pre-consumption, immediately post-consumption, and 30, 60, 120, and 180 minutes post-consumption |
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|
| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | 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 | 0 | 10 | 0 | 10 | 0 | 10 |
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| Title | Measurements |
|---|---|
|
| 60 min |
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| 120 min |
|
| 180 min |
|
| Title | Measurements |
|---|---|
|
| 60 min |
|
| 120 min |
|
| 180 min |
|
| Title | Measurements |
|---|---|
|
| 60 min |
|
| 120 min |
|
| 180 min |
|