Food HabitsNCT06509204
Real-world Evaluation of JBA GlucoTrojan With Reducose® on Glycemic Response
A study testing Glucotrojan in people with Food Habits, run by Tastermonial Inc at 1 site in United States.
Trial summary
The project is focused on evaluating the real-world efficacy of JBA GlucoTrojan, a powdered supplement sachet containing Reducose, a natural water extract of White Mulberry Leaf, which has been scientifically proven to reduce the absorption of sugars and carbs by up to 40%. Read more about this study
- Who is it for?
- Ages 21 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Food Habits
- What is being tested?
- Glucotrojan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Apr 2023to 4 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 21 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Consent to study protocol
- BMI: 18.5 to 29.9 kg/m2
- 21 to 75 years old
Who cannot join
- Physician-diagnosed T1D and insulin-dependent T2D
- Taking medications that modulate blood glucose response or control blood pressure other than Metformin
- An underlying health condition that warrants non-participation
- Individuals who are pregnant
- Any other dietary restrictions that prevent them from consuming study foods
- Unable to follow remote guidance via the Internet or smartphone
- Unable to follow controlled diet instructions
- Unable to use a CGM (Continuous Glucose Monitoring Devices)
Trial locations and contacts
1 site in 1 country.
About this study
The project is focused on evaluating the real-world efficacy of JBA GlucoTrojan, a powdered supplement sachet containing Reducose, a natural water extract of White Mulberry Leaf, which has been scientifically proven to reduce the absorption of sugars and carbs by up to 40%. The study aims to compare the effect of consuming GlucoTrojan with a meal (Test Meal) vs. having the meal alone (control) on the blood sugar response of 50 healthy adults, pre-diabetes, or non-insulin dependent diabetes, over a period of 14 days. It is expected that GlucoTrojan will reduce the incremental area under the curve and the peak for plasma glucose concentration over 120 minutes in normoglycemic adults when compared to the response to a control meal.
- Conditions
- Food Habits
- Being tested
- Glucotrojan
- Medical subject headings
- Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlucotrojanDietary supplement
Day 1: Start wearing the CGM sensor and let it self-calibrate for 24 h Day 2: Consume 1 serving of Test Meal for breakfast. Log the meal in the app. Day 3: Consume 1 serving of Test Meal with GlucoTrojan for breakfast. Log the meal in the app.
Days 4-8: Participants will be instructed to take GlucoTrojan twice per day. Once during their typical breakfast meal and once during their typical dinner meal. Each breakfast and dinner will be logged in the app.
Days 9-13: Participants will continue with their typical lives but continue to log meals - breakfast and dinner - in the app.
Day 14: end
| Study group | Role | What they receive |
|---|---|---|
| Consumer | Experimental | AQP Pharmaceuticals, Inc. ("Company") developed a powdered supplement sachet that can be added to meals targeting consumers who follow carbohydrate-heavy Asian diets. The product is formulated with the patented ingredient, "Reducose®", a natural water extract of novel White Mulberry Leaf that has been scientifically proven to reduce the absorption of sugars and other carbs by up to 40%. The effects have been confirmed previously via Randomized, Double-Blind, Controlled Trials.
The Company is looking to conduct a real-world study of blood glucose responses to JBA GlucoTrojan (see specifications here) with a 5% concentration of Reducose®. The study will observe the real-world efficacy of GlucoTrojan when taken with high carbohydrate meals. Receives: Dietary Supplement: Glucotrojan |
What is being measured
The primary outcome is the main question the study is designed to answer.
iAUC Calculation
Each participant's eating period (called a "meal") is normalized and overlaid in a data frame that captures glucose values over the course of the test. Several other metrics are computed, such as maximum and minimum values, standard deviation, and others. In particular, the iAUC ("incremental area under the curve"), a measure of the total amount of postprandial blood glucose level increased over the entire 2-hour period after eating. The methodology of iAUC calculation follows the gold standard used in the measurement of the glycemic index (1, 2). The iAUC metric allows our team to easily compare and rank testing results, as well as compare against the pure sugar responses or the sugar tolerance test of an individual.
Measured: 2-hour period after eating
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2024
- Study start4 Apr 2023
- Primary completion4 Jun 2023
- Study completion4 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Food HabitsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tastermonial Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- WCG clinical, Affordable Quality Pharmaceuticals
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06509204
- Sponsor's protocol ID
- 1351713
- Status last verified
- Jul 2024
- First submitted
- 28 Jun 2024
- Last updated
- 19 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Freckmann G, Hagenlocher S, Baumstark A, Jendrike N, Gillen RC, Rossner K, Haug C. Continuous glucose profiles in healthy subjects under everyday life conditions and after different meals. J Diabetes Sci Technol. 2007 Sep;1(5):695-703. doi: 10.1177/193229680700100513.
PubMed 19885137Zhou J, Li H, Ran X, Yang W, Li Q, Peng Y, Li Y, Gao X, Luan X, Wang W, Jia W. Reference values for continuous glucose monitoring in Chinese subjects. Diabetes Care. 2009 Jul;32(7):1188-93. doi: 10.2337/dc09-0076. Epub 2009 Apr 23.
PubMed 19389816Shah VN, DuBose SN, Li Z, Beck RW, Peters AL, Weinstock RS, Kruger D, Tansey M, Sparling D, Woerner S, Vendrame F, Bergenstal R, Tamborlane WV, Watson SE, Sherr J. Continuous Glucose Monitoring Profiles in Healthy Nondiabetic Participants: A Multicenter Prospective Study. J Clin Endocrinol Metab. 2019 Oct 1;104(10):4356-4364. doi: 10.1210/jc.2018-02763.
PubMed 31127824Rodriguez-Segade S, Rodriguez J, Camina F, Fernandez-Arean M, Garcia-Ciudad V, Pazos-Couselo M, Garcia-Lopez JM, Alonso-Sampedro M, Gonzalez-Quintela A, Gude F. Continuous glucose monitoring is more sensitive than HbA1c and fasting glucose in detecting dysglycaemia in a Spanish population without diabetes. Diabetes Res Clin Pract. 2018 Aug;142:100-109. doi: 10.1016/j.diabres.2018.05.026. Epub 2018 May 26.
PubMed 29807103Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group; Fox LA, Beck RW, Xing D. Variation of interstitial glucose measurements assessed by continuous glucose monitors in healthy, nondiabetic individuals. Diabetes Care. 2010 Jun;33(6):1297-9. doi: 10.2337/dc09-1971. Epub 2010 Mar 9.
PubMed 20215454
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-world Evaluation of JBA GlucoTrojan With Reducose® on Glycemic Response
- ClinicalTrials.gov ID
- NCT06509204
- Acronym / sponsor ID
- 1351713
- Conditions
- Food Habits
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Tastermonial IncIndustry (pharma, biotech, devices)
- Collaborators
- WCG clinical, Affordable Quality Pharmaceuticals
- Study start
- 4 Apr 2023 (actual)
- Primary completion
- 4 Jun 2023 (actual)
- Study completion
- 4 Jun 2023 (actual)
- First posted
- 19 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The project is focused on evaluating the real-world efficacy of JBA GlucoTrojan, a powdered supplement sachet containing Reducose, a natural water extract of White Mulberry Leaf, which has been scientifically proven to reduce the absorption of sugars and carbs by up to 40%. The study aims to compare the effect of consuming GlucoTrojan with a meal (Test Meal) vs. having the meal alone (control) on the blood sugar response of 50 healthy adults, pre-diabetes, or non-insulin dependent diabetes, over a period of 14 days. It is expected that GlucoTrojan will reduce the incremental area under the curve and the peak for plasma glucose concentration over 120 minutes in normoglycemic adults when compared to the response to a control meal.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Consumer | Experimental | Dietary Supplement: GlucotrojanAQP Pharmaceuticals, Inc. ("Company") developed a powdered supplement sachet that can be added to meals targeting consumers who follow carbohydrate-heavy Asian diets. The product is formulated with the patented ingredient, "Reducose®", a natural water extract of novel White Mulberry Leaf that has been scientifically proven to reduce the absorption of sugars and other carbs by up to 40%. The effects have been confirmed previously via Randomized, Double-Blind, Controlled Trials. The Company is looking to conduct a real-world study of blood glucose responses to JBA GlucoTrojan (see specifications here) with a 5% concentration of Reducose®. The study will observe the real-world efficacy of GlucoTrojan when taken with high carbohydrate meals. |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Consent to study protocol
- BMI: 18.5 to 29.9 kg/m2
- 21 to 75 years old
Key exclusion criteria (8 listed)
- Physician-diagnosed T1D and insulin-dependent T2D
- Taking medications that modulate blood glucose response or control blood pressure other than Metformin
- An underlying health condition that warrants non-participation
- Individuals who are pregnant
- Any other dietary restrictions that prevent them from consuming study foods
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 |
|---|---|---|
| GlucotrojanDay 1: Start wearing the CGM sensor and let it self-calibrate for 24 h Day 2: Consume 1 serving of Test Meal for breakfast. Log the meal in the app. Day 3: Consume 1 serving of Test Meal with GlucoTrojan for breakfast. Log the meal in the app. Days 4-8: Participants will be instructed to take GlucoTrojan twice per day. Once during their typical breakfast meal and once during their typical dinner meal. Each breakfast and dinner will be logged in the app. Days 9-13: Participants will continue with their typical lives but continue to log meals - breakfast and dinner - in the app. Day 14: end | Dietary supplement | Consumer |
Primary outcome
iAUC Calculation
Time frame: 2-hour period after eating
Each participant's eating period (called a "meal") is normalized and overlaid in a data frame that captures glucose values over the course of the test. Several other metrics are computed, such as maximum and minimum values, standard deviation, and others. In particular, the iAUC ("incremental area under the curve"), a measure of the total amount of postprandial blood glucose level increased over the entire 2-hour period after eating. The methodology of iAUC calculation follows the gold standard used in the measurement of the glycemic index (1, 2). The iAUC metric allows our team to easily compare and rank testing results, as well as compare against the pure sugar responses or the sugar tolerance test of an individual.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2024.
- Background: PubMed 19885137Freckmann G, Hagenlocher S, Baumstark A, Jendrike N, Gillen RC, Rossner K, Haug C. Continuous glucose profiles in healthy subjects under everyday life conditions and after different meals. J Diabetes Sci Technol. 2007 Sep;1(5):695-703. doi: 10.1177/193229680700100513.
- Background: PubMed 19389816Zhou J, Li H, Ran X, Yang W, Li Q, Peng Y, Li Y, Gao X, Luan X, Wang W, Jia W. Reference values for continuous glucose monitoring in Chinese subjects. Diabetes Care. 2009 Jul;32(7):1188-93. doi: 10.2337/dc09-0076. Epub 2009 Apr 23.
- Background: PubMed 31127824Shah VN, DuBose SN, Li Z, Beck RW, Peters AL, Weinstock RS, Kruger D, Tansey M, Sparling D, Woerner S, Vendrame F, Bergenstal R, Tamborlane WV, Watson SE, Sherr J. Continuous Glucose Monitoring Profiles in Healthy Nondiabetic Participants: A Multicenter Prospective Study. J Clin Endocrinol Metab. 2019 Oct 1;104(10):4356-4364. doi: 10.1210/jc.2018-02763.
- Background: PubMed 29807103Rodriguez-Segade S, Rodriguez J, Camina F, Fernandez-Arean M, Garcia-Ciudad V, Pazos-Couselo M, Garcia-Lopez JM, Alonso-Sampedro M, Gonzalez-Quintela A, Gude F. Continuous glucose monitoring is more sensitive than HbA1c and fasting glucose in detecting dysglycaemia in a Spanish population without diabetes. Diabetes Res Clin Pract. 2018 Aug;142:100-109. doi: 10.1016/j.diabres.2018.05.026. Epub 2018 May 26.
- Background: PubMed 20215454Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group; Fox LA, Beck RW, Xing D. Variation of interstitial glucose measurements assessed by continuous glucose monitors in healthy, nondiabetic individuals. Diabetes Care. 2010 Jun;33(6):1297-9. doi: 10.2337/dc09-1971. Epub 2010 Mar 9.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glucotrojan in people with Food Habits, run by Tastermonial Inc 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 3 inclusion and 8 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 19 Jul 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
iAUC Calculation (time frame: 2-hour period after eating). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06509204, which also lists 5 linked publications.
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 19 Jul 2024.