Healthy
Conditions
Keywords
Carbohydrate blocking supplement, Continuous Glucose Monitoring, Interstitial glucose levels
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTCarbohydrate 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_SUPPLEMENTPlacebo capsule
The placebo is composed of a Hypromellose outer shell filled with extra virgin olive oil.
Sponsors
dōTERRA International
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Masking description
Cohort 1 is single-blind. Participants will not know their treatment allocation in either arm of the study. Furthermore, in cohort 1, the participants may receive a 250 mg or 500 mg CBS dose, but will not be informed which they receive. In order to preserve blinding to dosage allocation, participants will be instructed to consume two capsules prior to each meal. * Participants receiving the 500 mg CBS dose will take 2 CBS capsules * Participants receiving the 250 mg CBS dose will take 1 CBS capsule and 1 placebo capsule * Participants in the placebo arm will take 2 placebo capsules Cohort 2 is double blind - participants will know that they will receive either the treatment or placebo first, but will be blinded to which they receive. All members of research staff will be blinded with the exception of a designated member
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
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
Exclusion criteria
* 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety/tolerability (cohort 1) | 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 | 2 weeks | Dosage for cohort 2 will be determined |
| Glucose levels monitoring (Cohort 2) | 2 months | Use of continuous glucose monitoring (CGM) to monitor interstitial glucose levels |
| Glycemic variability (Cohort 2) | 2 months | Glycemic variability will be determined in healthy individuals. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Creatinine (mg/dL) | 2 weeks (Cohort 1), 2 months (Cohort 2) | Item in comprehensive metabolic panel for safety assessment |
| Alkaline phosphatase (U/L) | 2 weeks (Cohort 1), 2 months (Cohort 2) | Item in comprehensive metabolic panel for safety assessment |
| ALT (U/L) | 2 weeks (Cohort 1), 2 months (Cohort 2) | Item in comprehensive metabolic panel for safety assessment |
| AST (U/L) | 2 weeks (Cohort 1), 2 months (Cohort 2) | Item in comprehensive metabolic panel for safety assessment |
| Calcium (mg/dL) | 2 weeks, 2 months (Cohort 2) | Item in comprehensive metabolic panel for safety assessment |
| Carbon Dioxide (mmol/L) | 2 weeks (Cohort 1), 2 months (Cohort 2) | Item in comprehensive metabolic panel for safety assessment |
| Chloride (mmol/L) | 2 weeks (Cohort 1), 2 months (Cohort 2) | Item in comprehensive metabolic panel for safety assessment |
| Albumin (g/dL) | 2 weeks (Cohort 1), 2 months (Cohort 2) | Item in comprehensive metabolic panel for safety assessment |
| Sodium (mmol/L) | 2 weeks (Cohort 1), 2 months (Cohort 2) | Item in comprehensive metabolic panel for safety assessment |
| Total bilirubin (mg/dL) | 2 weeks (Cohort 1), 2 months (Cohort 2) | Item in comprehensive metabolic panel for safety assessment |
| Total protein (g/dL) | 2 weeks (Cohort 1), 2 months (Cohort 2) | Item in comprehensive metabolic panel for safety assessment |
| Fasting insulin | 2 weeks (Cohort 1), 2 months (Cohort 2) | Fasting insulin to determine changes, if any, to metabolism. |
| Fasting glucose | 2 weeks (Cohort 1), 2 months (Cohort 2) | Fasting glucose to determine changes, if any, to metabolism. |
| Body weight | 2 weeks (Cohort 1), 2 months (Cohort 2) | Determine whether body weight is affected by the consumption of the study product. |
| Safety/tolerability (cohort 2) | 2 months | This study will monitor the occurrence and frequency of adverse events and safety, both through participant report and blood chemistry/hematology analyses. |
| Potassium (mmol/L) | 2 weeks (Cohort 1), 2 months (Cohort 2) | Item in comprehensive metabolic panel for safety assessment |
| Glucose levels monitoring (Cohort 1) | 2 weeks | Use of continuous glucose monitoring (CGM) to monitor interstitial glucose levels |
| Glycemic variability (Cohort 1) | 2 weeks | Use of continuous glucose monitoring (CGM) to monitor interstitial glucose levels and Glycemic variability will be determined in healthy individuals. |
| BUN (mg/dL) | 2 weeks (Cohort 1), 2 months (Cohort 2) | Item in comprehensive metabolic panel for safety assessment |
Countries
United States
Outcome results
None listed