HealthyNCT05832463
Effects of a Novel Supplement on Glycemic Variability Measured by Continuous Glucose Monitoring
A study testing Carbohydrate blocking supplement (CBS) in people with Healthy, run by dōTERRA International at 1 site in United States.
Trial summary
This is a two-cohort, crossover pilot study to determine interstitial glucose levels coincident with the consumption of a novel carbohydrate blocking supplement. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Carbohydrate blocking supplement (CBS)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- 14 May 2021to 15 Jul 2022
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- If female, negative pregnancy test
- Body mass index (BMI) ≤ 32
- HbA1C ≤ 6.4% at screening
- Fasting blood glucose level ≤ 125 mg/dL at screening
- [COHORT 1 ONLY] Willing and able (in the opinion of the investigator) to comply with all study requirements, including swallowing size 00 capsules (approximately 23 mm long and 8.5 mm diameter), food journaling, consumption of a standardized, high carbohydrate meal daily, CGM device application, and phlebotomy
- [COHORT 2 ONLY] Willing and able (in the opinion of the investigator) to comply with all study requirements, including swallowing size 00 capsules (approximately 23 mm long and 8.5 mm diameter), CGM device application, and phlebotomy
- Signed informed consent, HIPAA Authorization, and Confidentiality Agreement
Who cannot join
- Pregnancy within the last 60 days or currently breastfeeding
- Existence of any medical condition, significant disease or disorder, or surgery within the past 12 months that may, in the judgment of the medical provider, put the participant at risk, or affect study results, procedures or outcomes
- Existence of any medical concerns, or any finding that may, in the judgment of the staff medical provider, put the participant at risk, or affect study results, procedures or outcome
- [COHORT 1 ONLY] Sensitivity or allergy to gluten, sugar, peanuts, apples, strawberries, dairy, or orange juice
- Known or suspected allergy or sensitivity to essential oil, fatty oils, cellulose, or botanical products
- Currently following a ketogenic or medically prescribed diet, or have followed a ketogenic or medically prescribed diet within the last 3 months
Show all 11Show fewer
- Arterial hypertension ≥140/90 mmHg.
- HbA1c ≥ 6.5% at screening
- Fasting blood glucose > 125 mg/dL at screening
- Current or previous participation in any other clinical trial within the last month
- History of smoking or vaping within the last 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of a Novel Carbohydrate Blocking Supplement on Glycemic Variability as Measured by Continuous Glucose Monitoring
This is a two-cohort, crossover pilot study to determine interstitial glucose levels coincident with the consumption of a novel carbohydrate blocking supplement.
Read the detailed description
This two-cohort study will evaluate a novel supplement developed for metabolic support using measures of glycemic variability, fasting glucose, and fasting insulin. In the first cohort, over the course of two weeks, these endpoints will be determined by continuous glucose monitoring (CGM) and blood/urine analyses in healthy adults using a carbohydrate blocking supplement (CBS). Following an interim analysis, the CBS will be evaluated for an additional two months in healthy volunteers using the same measures outlined above.
- Conditions
- Healthy
- Being tested
- Carbohydrate blocking supplement (CBS), Placebo capsule
- Keywords
- Carbohydrate blocking supplement, Continuous Glucose Monitoring, Interstitial glucose levels
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carbohydrate blocking supplement (CBS)Dietary supplement
The CBS is composed of a Hypromellose outer shell, and filled with mulberry leaf extract, berberine HCl, cinnamon bark powder, and cinnamon bark essential oil.
Mulberry leaf extract (Reducose) - 250 mg Berberine HCl (97%)(Berberis aristata root extract)- 25 mg Organic cinnamon powder (Cinnamon (Cinnamomum loureirii) bark powder) - 20 mg Essential oil blend (Grapefruit (Citrus paradisii) peel oil, Lemon (Citrus limon) peel oil Peppermint (Mentha piperita) aerial (leaf/stem) oil), Ginger (Zingiber officinale) root oil, Cinnamon (Cinnamomum zeylanicum) bark oil) - 5 mg
Placebo capsuleDietary supplement
The placebo is composed of a Hypromellose outer shell filled with extra virgin olive oil.
| Study group | Role | What they receive |
|---|---|---|
| Experimental arm | Experimental | In cohort 1, participants will receive either a 250 mg mulberry leaf extract CBS dose (1 supplement capsule t.i.d. + 1 placebo capsule to preserve blinding) or a 500 mg mulberry leaf extract CBS dose (2 supplements t.i.d.) in the experimental arm and will cross over to or from the placebo arm.
In cohort 2, participants will receive a 500 mg mulberry leaf extract CBS dose (2 supplement capsules t.i.d.) in the experimental arm and will cross over to or from the placebo arm. Receives: Dietary Supplement: Carbohydrate blocking supplement (CBS) |
| Placebo arm | Placebo comparator | In Cohorts 1 and 2, participants will receive 2 placebo capsules in the placebo arm and will cross over to or from the experimental arm. Receives: Dietary Supplement: Placebo capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety/tolerability (cohort 1)
This study will monitor the occurrence and frequency of adverse events and safety, both through participant report and blood chemistry/hematology analyses. Dosage for cohort 2 will be determined
Measured: 2 weeks
Dose determination for Cohort 2
Dosage for cohort 2 will be determined
Measured: 2 weeks
Glucose levels monitoring (Cohort 2)
Use of continuous glucose monitoring (CGM) to monitor interstitial glucose levels
Measured: 2 months
Glycemic variability (Cohort 2)
Glycemic variability will be determined in healthy individuals.
Measured: 2 months
Secondary outcomes (19)
Glucose levels monitoring (Cohort 1)
Use of continuous glucose monitoring (CGM) to monitor interstitial glucose levels
Measured: 2 weeks
Glycemic variability (Cohort 1)
Use of continuous glucose monitoring (CGM) to monitor interstitial glucose levels and Glycemic variability will be determined in healthy individuals.
Measured: 2 weeks
Albumin (g/dL)
Item in comprehensive metabolic panel for safety assessment
Measured: 2 weeks (Cohort 1), 2 months (Cohort 2)
BUN (mg/dL)
Item in comprehensive metabolic panel for safety assessment
Measured: 2 weeks (Cohort 1), 2 months (Cohort 2)
Creatinine (mg/dL)
Item in comprehensive metabolic panel for safety assessment
Measured: 2 weeks (Cohort 1), 2 months (Cohort 2)
Alkaline phosphatase (U/L)
Item in comprehensive metabolic panel for safety assessment
Measured: 2 weeks (Cohort 1), 2 months (Cohort 2)
ALT (U/L)
Item in comprehensive metabolic panel for safety assessment
Measured: 2 weeks (Cohort 1), 2 months (Cohort 2)
AST (U/L)
Item in comprehensive metabolic panel for safety assessment
Measured: 2 weeks (Cohort 1), 2 months (Cohort 2)
Calcium (mg/dL)
Item in comprehensive metabolic panel for safety assessment
Measured: 2 weeks, 2 months (Cohort 2)
Carbon Dioxide (mmol/L)
Item in comprehensive metabolic panel for safety assessment
Measured: 2 weeks (Cohort 1), 2 months (Cohort 2)
Chloride (mmol/L)
Item in comprehensive metabolic panel for safety assessment
Measured: 2 weeks (Cohort 1), 2 months (Cohort 2)
Potassium (mmol/L)
Item in comprehensive metabolic panel for safety assessment
Measured: 2 weeks (Cohort 1), 2 months (Cohort 2)
Sodium (mmol/L)
Item in comprehensive metabolic panel for safety assessment
Measured: 2 weeks (Cohort 1), 2 months (Cohort 2)
Total bilirubin (mg/dL)
Item in comprehensive metabolic panel for safety assessment
Measured: 2 weeks (Cohort 1), 2 months (Cohort 2)
Total protein (g/dL)
Item in comprehensive metabolic panel for safety assessment
Measured: 2 weeks (Cohort 1), 2 months (Cohort 2)
Fasting insulin
Fasting insulin to determine changes, if any, to metabolism.
Measured: 2 weeks (Cohort 1), 2 months (Cohort 2)
Fasting glucose
Fasting glucose to determine changes, if any, to metabolism.
Measured: 2 weeks (Cohort 1), 2 months (Cohort 2)
Body weight
Determine whether body weight is affected by the consumption of the study product.
Measured: 2 weeks (Cohort 1), 2 months (Cohort 2)
Safety/tolerability (cohort 2)
This study will monitor the occurrence and frequency of adverse events and safety, both through participant report and blood chemistry/hematology analyses.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2023
- Study start14 May 2021
- Primary completion12 Jul 2022
- Study completion15 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- dōTERRA International
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Russell Osguthorpe, MD, Principal investigator, doTERRA International
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05832463
- Sponsor's protocol ID
- DO-120043-CBS
- Status last verified
- Apr 2023
- First submitted
- 10 Mar 2023
- Last updated
- 27 Apr 2023
- Results posted
- No
- 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 27 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Novel Carbohydrate Blocking Supplement on Glycemic Variability as Measured by Continuous Glucose Monitoring
- ClinicalTrials.gov ID
- NCT05832463
- Acronym / sponsor ID
- DO-120043-CBS
- Conditions
- Healthy
- Keywords
- Carbohydrate blocking supplement, Continuous Glucose Monitoring, Interstitial glucose levels
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- dōTERRA InternationalIndustry (pharma, biotech, devices)
- Study start
- 14 May 2021 (actual)
- Primary completion
- 12 Jul 2022 (actual)
- Study completion
- 15 Jul 2022 (actual)
- First posted
- 27 Apr 2023 (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.
This is a two-cohort, crossover pilot study to determine interstitial glucose levels coincident with the consumption of a novel carbohydrate blocking supplement.
Detailed description
This two-cohort study will evaluate a novel supplement developed for metabolic support using measures of glycemic variability, fasting glucose, and fasting insulin. In the first cohort, over the course of two weeks, these endpoints will be determined by continuous glucose monitoring (CGM) and blood/urine analyses in healthy adults using a carbohydrate blocking supplement (CBS). Following an interim analysis, the CBS will be evaluated for an additional two months in healthy volunteers using the same measures outlined above.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental arm | Experimental | Dietary Supplement: Carbohydrate blocking supplement (CBS)In cohort 1, participants will receive either a 250 mg mulberry leaf extract CBS dose (1 supplement capsule t.i.d. + 1 placebo capsule to preserve blinding) or a 500 mg mulberry leaf extract CBS dose (2 supplements t.i.d.) in the experimental arm and will cross over to or from the placebo arm. In cohort 2, participants will receive a 500 mg mulberry leaf extract CBS dose (2 supplement capsules t.i.d.) in the experimental arm and will cross over to or from the placebo arm. |
| Placebo arm | Placebo comparator | Dietary Supplement: Placebo capsuleIn Cohorts 1 and 2, participants will receive 2 placebo capsules in the placebo arm and will cross over to or from the experimental arm. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- If female, negative pregnancy test
- Body mass index (BMI) ≤ 32
- HbA1C ≤ 6.4% at screening
- Fasting blood glucose level ≤ 125 mg/dL at screening
- [COHORT 1 ONLY] Willing and able (in the opinion of the investigator) to comply with all study requirements, including swallowing size 00 capsules (approximately 23 mm long and 8.5 mm diameter), food journaling, consumption of a standardized, high carbohydrate meal daily, CGM device application, and phlebotomy
Key exclusion criteria (11 listed)
- Pregnancy within the last 60 days or currently breastfeeding
- Existence of any medical condition, significant disease or disorder, or surgery within the past 12 months that may, in the judgment of the medical provider, put the participant at risk, or affect study results, procedures or outcomes
- Existence of any medical concerns, or any finding that may, in the judgment of the staff medical provider, put the participant at risk, or affect study results, procedures or outcome
- [COHORT 1 ONLY] Sensitivity or allergy to gluten, sugar, peanuts, apples, strawberries, dairy, or orange juice
- Known or suspected allergy or sensitivity to essential oil, fatty oils, cellulose, or botanical products
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 |
|---|---|---|
| Carbohydrate blocking supplement (CBS)The CBS is composed of a Hypromellose outer shell, and filled with mulberry leaf extract, berberine HCl, cinnamon bark powder, and cinnamon bark essential oil. Mulberry leaf extract (Reducose) - 250 mg Berberine HCl (97%)(Berberis aristata root extract)- 25 mg Organic cinnamon powder (Cinnamon (Cinnamomum loureirii) bark powder) - 20 mg Essential oil blend (Grapefruit (Citrus paradisii) peel oil, Lemon (Citrus limon) peel oil Peppermint (Mentha piperita) aerial (leaf/stem) oil), Ginger (Zingiber officinale) root oil, Cinnamon (Cinnamomum zeylanicum) bark oil) - 5 mg | Dietary supplement | Experimental arm |
| Placebo capsuleThe placebo is composed of a Hypromellose outer shell filled with extra virgin olive oil. | Dietary supplement | Placebo arm |
Primary outcome
Safety/tolerability (cohort 1)
Time frame: 2 weeks
This study will monitor the occurrence and frequency of adverse events and safety, both through participant report and blood chemistry/hematology analyses. Dosage for cohort 2 will be determined
Dose determination for Cohort 2
Time frame: 2 weeks
Dosage for cohort 2 will be determined
Glucose levels monitoring (Cohort 2)
Time frame: 2 months
Use of continuous glucose monitoring (CGM) to monitor interstitial glucose levels
Glycemic variability (Cohort 2)
Time frame: 2 months
Glycemic variability will be determined in healthy individuals.
19 secondary outcomes
Glucose levels monitoring (Cohort 1)
Time frame: 2 weeks
Glycemic variability (Cohort 1)
Time frame: 2 weeks
Albumin (g/dL)
Time frame: 2 weeks (Cohort 1), 2 months (Cohort 2)
BUN (mg/dL)
Time frame: 2 weeks (Cohort 1), 2 months (Cohort 2)
Creatinine (mg/dL)
Time frame: 2 weeks (Cohort 1), 2 months (Cohort 2)
Alkaline phosphatase (U/L)
Time frame: 2 weeks (Cohort 1), 2 months (Cohort 2)
ALT (U/L)
Time frame: 2 weeks (Cohort 1), 2 months (Cohort 2)
AST (U/L)
Time frame: 2 weeks (Cohort 1), 2 months (Cohort 2)
Calcium (mg/dL)
Time frame: 2 weeks, 2 months (Cohort 2)
Carbon Dioxide (mmol/L)
Time frame: 2 weeks (Cohort 1), 2 months (Cohort 2)
Chloride (mmol/L)
Time frame: 2 weeks (Cohort 1), 2 months (Cohort 2)
Potassium (mmol/L)
Time frame: 2 weeks (Cohort 1), 2 months (Cohort 2)
Sodium (mmol/L)
Time frame: 2 weeks (Cohort 1), 2 months (Cohort 2)
Total bilirubin (mg/dL)
Time frame: 2 weeks (Cohort 1), 2 months (Cohort 2)
Total protein (g/dL)
Time frame: 2 weeks (Cohort 1), 2 months (Cohort 2)
Fasting insulin
Time frame: 2 weeks (Cohort 1), 2 months (Cohort 2)
Fasting glucose
Time frame: 2 weeks (Cohort 1), 2 months (Cohort 2)
Body weight
Time frame: 2 weeks (Cohort 1), 2 months (Cohort 2)
Safety/tolerability (cohort 2)
Time frame: 2 months
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 27 Apr 2023.
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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.
Russell Osguthorpe, MD principal investigator
doTERRA International
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carbohydrate blocking supplement (CBS) in people with Healthy, run by dōTERRA International 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 7 inclusion and 11 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 27 Apr 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. Some participants in this study may receive a placebo. 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?
Safety/tolerability (cohort 1) (time frame: 2 weeks). The study lists 4 primary outcomes in all. 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 27 Apr 2023.