Effects of a Novel Supplement on Glycemic Variability Measured by Continuous Glucose Monitoring
- Conditions
- Healthy
- Interventions
- Dietary Supplement: Carbohydrate blocking supplement (CBS)Dietary Supplement: Placebo capsule
- Registration Number
- NCT05832463
- Lead Sponsor
- dōTERRA International
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 43
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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Experimental arm 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 capsule 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.
- Primary Outcome Measures
Name Time Method 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.
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
- Secondary Outcome Measures
Name Time Method 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.
Albumin (g/dL) 2 weeks (Cohort 1), 2 months (Cohort 2) Item in comprehensive metabolic panel for safety assessment
BUN (mg/dL) 2 weeks (Cohort 1), 2 months (Cohort 2) Item in comprehensive metabolic panel for safety assessment
Fasting glucose 2 weeks (Cohort 1), 2 months (Cohort 2) Fasting glucose to determine changes, if any, to metabolism.
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
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.
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
Potassium (mmol/L) 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.
Trial Locations
- Locations (1)
doTERRA International
🇺🇸Pleasant Grove, Utah, United States