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

dōTERRA International43 enrolled

Overview

This is a two-cohort, crossover pilot study to determine interstitial glucose levels coincident with the consumption of a novel carbohydrate blocking supplement.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Enrollment

Conditions

Healthy

Interventions

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

doTERRA International

Pleasant Grove, Utah, United States

Outcomes

Primary Outcomes

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

Time frame: 2 weeks

Dose determination for Cohort 2

Dosage for cohort 2 will be determined

Time frame: 2 weeks

Glucose levels monitoring (Cohort 2)

Use of continuous glucose monitoring (CGM) to monitor interstitial glucose levels

Time frame: 2 months

Glycemic variability (Cohort 2)

Glycemic variability will be determined in healthy individuals.

Time frame: 2 months

Secondary Outcomes

Glucose levels monitoring (Cohort 1)

Use of continuous glucose monitoring (CGM) to monitor interstitial glucose levels

Time frame: 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.

Time frame: 2 weeks

Albumin (g/dL)

Item in comprehensive metabolic panel for safety assessment

Time frame: 2 weeks (Cohort 1), 2 months (Cohort 2)

BUN (mg/dL)

Item in comprehensive metabolic panel for safety assessment

Data from ClinicalTrials.gov

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