Diabetes PreventionNCT05130593
Pilot Study Evaluating the Acceptability and Absorption of the Bioactive Compounds of a Russian Tarragon Nutrasorb Bar
An observational study of Diabetes Prevention, run by Pennington Biomedical Research Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Prevention
- What is being tested?
- Nutrasorb bar
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Oct 2021to 31 Oct 2022
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: healthy males and females aged 18-50 with a body mass index between 20-30 kg/m2
Who may be able to join
- Healthy males or females between 18 and 50 years of age inclusive.
- Body mass index between 20-30 kg/m2.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
About this study
Official title: Pilot Study Evaluating the Hedonic Acceptability and Absorption of the Bioactive Compounds of a 5011-Nutrasorb Bar (Russian Tarragon Nutrasorb)
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.
Read the 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.
- Conditions
- Diabetes Prevention
- Being tested
- Nutrasorb bar
- Keywords
- tarragon
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrasorb barDietary supplement
250 kcal bar containing 30 g of 5011-Nutrasorb (120 kcal), 20 g fat (100 kcal), and 30 kcal from carbohydrate and flavorings
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Dietary Supplement: Nutrasorb bar |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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
Measured: 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.
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
Measured: 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
Measured: 10 minutes pre-consumption, immediately post-consumption, and 30, 60, 120, and 180 minutes post-consumption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2021
- Study start25 Oct 2021
- Primary completion31 Oct 2022
- Study completion31 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diabetes PreventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH), Office of Dietary Supplements (ODS)
- Responsible party
- Principal investigator, Jennifer C. Rood, Pennington Biomedical Research Center
- Investigators
- Jennifer C Rood, Ph.D., Principal investigator, Pennington Biomedical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05130593
- Sponsor's protocol ID
- PBRC 2020-022
- Other IDs
- 5P50AT002776-15
- Status last verified
- Nov 2023
- First submitted
- 6 Oct 2021
- Last updated
- 18 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study Evaluating the Hedonic Acceptability and Absorption of the Bioactive Compounds of a 5011-Nutrasorb Bar (Russian Tarragon Nutrasorb)
- ClinicalTrials.gov ID
- NCT05130593
- Acronym / sponsor ID
- PBRC 2020-022
- Conditions
- Diabetes Prevention
- Keywords
- tarragon
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH), Office of Dietary Supplements (ODS)
- Study start
- 25 Oct 2021 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 31 Oct 2022 (actual)
- First posted
- 23 Nov 2021 (actual)
- Results
- Posted 18 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nutrasorb bar evaluation | – | Dietary Supplement: Nutrasorb barParticipants 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). |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- healthy males and females aged 18-50 with a body mass index between 20-30 kg/m2
Key inclusion criteria (2 listed)
- Healthy males or females between 18 and 50 years of age inclusive.
- Body mass index between 20-30 kg/m2.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutrasorb bar250 kcal bar containing 30 g of 5011-Nutrasorb (120 kcal), 20 g fat (100 kcal), and 30 kcal from carbohydrate and flavorings | Dietary supplement | Nutrasorb bar evaluation |
Primary outcome
Palatability of Bar
Time frame: 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.
3 secondary outcomes
Levels of Plasma BIoactive (DMC-2) Before and After Ingestion of a Bar Containing PMI-5011/Nutrasorb.
Time frame: 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.
Time frame: 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.
Time frame: 10 minutes pre-consumption, immediately post-consumption, and 30, 60, 120, and 180 minutes post-consumption
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer C Rood, Ph.D. principal investigator
Pennington Biomedical Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Prevention, run by Pennington Biomedical Research Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Palatability of Bar (time frame: Test Day (immediately after taste-testing the bar)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.