Clinical trial NCT05832463: Effects of a Novel Supplement on Glycemic Variability Measured by Continuous Glucose Monitoring
Official title: Effects of a Novel Carbohydrate Blocking Supplement on Glycemic Variability as Measured by Continuous Glucose Monitoring
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Carbohydrate blocking supplement
Continuous Glucose Monitoring
Interstitial glucose levels
Lead sponsor: dōTERRA International
Sponsor class: INDUSTRY
First posted: 2023-04-27
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Safety/tolerability (cohort 1)
timeFrame: 2 weeks
measure: Dose determination for Cohort 2
timeFrame: 2 weeks
measure: Glucose levels monitoring (Cohort 2)
timeFrame: 2 months
measure: Glycemic variability (Cohort 2)
timeFrame: 2 months
Secondary outcomes:
measure: Glucose levels monitoring (Cohort 1)
timeFrame: 2 weeks
measure: Glycemic variability (Cohort 1)
timeFrame: 2 weeks
measure: Albumin (g/dL)
timeFrame: 2 weeks (Cohort 1), 2 months (Cohort 2)
measure: BUN (mg/dL)
timeFrame: 2 weeks (Cohort 1), 2 months (Cohort 2)
measure: Creatinine (mg/dL)
timeFrame: 2 weeks (Cohort 1), 2 months (Cohort 2)
measure: Alkaline phosphatase (U/L)
timeFrame: 2 weeks (Cohort 1), 2 months (Cohort 2)
measure: ALT (U/L)
timeFrame: 2 weeks (Cohort 1), 2 months (Cohort 2)
measure: AST (U/L)
timeFrame: 2 weeks (Cohort 1), 2 months (Cohort 2)
measure: Calcium (mg/dL)
timeFrame: 2 weeks, 2 months (Cohort 2)
measure: Carbon Dioxide (mmol/L)
timeFrame: 2 weeks (Cohort 1), 2 months (Cohort 2)
measure: Chloride (mmol/L)
timeFrame: 2 weeks (Cohort 1), 2 months (Cohort 2)
measure: Potassium (mmol/L)
timeFrame: 2 weeks (Cohort 1), 2 months (Cohort 2)
measure: Sodium (mmol/L)
timeFrame: 2 weeks (Cohort 1), 2 months (Cohort 2)
measure: Total bilirubin (mg/dL)
timeFrame: 2 weeks (Cohort 1), 2 months (Cohort 2)
measure: Total protein (g/dL)
timeFrame: 2 weeks (Cohort 1), 2 months (Cohort 2)
measure: Fasting insulin
timeFrame: 2 weeks (Cohort 1), 2 months (Cohort 2)
measure: Fasting glucose
timeFrame: 2 weeks (Cohort 1), 2 months (Cohort 2)
measure: Body weight
timeFrame: 2 weeks (Cohort 1), 2 months (Cohort 2)
measure: Safety/tolerability (cohort 2)
timeFrame: 2 months
Other outcomes:
Locations:
city: Pleasant Grove
country: United States
facility: doTERRA International
state: Utah
Study officials:
affiliation: doTERRA International
name: Russell Osguthorpe, MD
role: PRINCIPAL_INVESTIGATOR
References: