Effects of a Novel Supplement on Glycemic Variability Measured by Continuous Glucose Monitoring

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effects of a Novel Carbohydrate Blocking Supplement on Glycemic Variability as Measured by Continuous Glucose Monitoring

Conditions
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Healthy

Intervention / Treatment
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* Dietary Supplement: Carbohydrate blocking supplement (CBS)
* Dietary Supplement: Placebo capsule


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental arm<br>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. | Dietary Supplement: Carbohydrate blocking supplement (CBS)<br>* 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<br>|
| Placebo Comparator: Placebo arm<br>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. | Dietary Supplement: Placebo capsule<br>* The placebo is composed of a Hypromellose outer shell filled with extra virgin olive oil.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 2 weeks | 
| Dose determination for Cohort 2 | Dosage for cohort 2 will be determined | 2 weeks | 
| Glucose levels monitoring (Cohort 2) | Use of continuous glucose monitoring (CGM) to monitor interstitial glucose levels | 2 months | 
| Glycemic variability (Cohort 2) | Glycemic variability will be determined in healthy individuals. | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose levels monitoring (Cohort 1) | Use of continuous glucose monitoring (CGM) to monitor interstitial glucose levels | 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. | 2 weeks | 
| Albumin (g/dL) | Item in comprehensive metabolic panel for safety assessment | 2 weeks (Cohort 1), 2 months (Cohort 2) | 
| BUN (mg/dL) | Item in comprehensive metabolic panel for safety assessment | 2 weeks (Cohort 1), 2 months (Cohort 2) | 
| Creatinine (mg/dL) | Item in comprehensive metabolic panel for safety assessment | 2 weeks (Cohort 1), 2 months (Cohort 2) | 
| Alkaline phosphatase (U/L) | Item in comprehensive metabolic panel for safety assessment | 2 weeks (Cohort 1), 2 months (Cohort 2) | 
| ALT (U/L) | Item in comprehensive metabolic panel for safety assessment | 2 weeks (Cohort 1), 2 months (Cohort 2) | 
| AST (U/L) | Item in comprehensive metabolic panel for safety assessment | 2 weeks (Cohort 1), 2 months (Cohort 2) | 
| Calcium (mg/dL) | Item in comprehensive metabolic panel for safety assessment | 2 weeks, 2 months (Cohort 2) | 
| Carbon Dioxide (mmol/L) | Item in comprehensive metabolic panel for safety assessment | 2 weeks (Cohort 1), 2 months (Cohort 2) | 
| Chloride (mmol/L) | Item in comprehensive metabolic panel for safety assessment | 2 weeks (Cohort 1), 2 months (Cohort 2) | 
| Potassium (mmol/L) | Item in comprehensive metabolic panel for safety assessment | 2 weeks (Cohort 1), 2 months (Cohort 2) | 
| Sodium (mmol/L) | Item in comprehensive metabolic panel for safety assessment | 2 weeks (Cohort 1), 2 months (Cohort 2) | 
| Total bilirubin (mg/dL) | Item in comprehensive metabolic panel for safety assessment | 2 weeks (Cohort 1), 2 months (Cohort 2) | 
| Total protein (g/dL) | Item in comprehensive metabolic panel for safety assessment | 2 weeks (Cohort 1), 2 months (Cohort 2) | 
| Fasting insulin | Fasting insulin to determine changes, if any, to metabolism. | 2 weeks (Cohort 1), 2 months (Cohort 2) | 
| Fasting glucose | Fasting glucose to determine changes, if any, to metabolism. | 2 weeks (Cohort 1), 2 months (Cohort 2) | 
| Body weight | Determine whether body weight is affected by the consumption of the study product. | 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. | 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Carbohydrate blocking supplement, Continuous Glucose Monitoring, Interstitial glucose levels