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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05832463
• Other study ID #: DO-120043-CBS
• Status: Completed
• Phase: N/A
• Start date: May 14, 2021
• Est. completion date: July 15, 2022

Study information

• Verified date: April 2023
• Source: doTERRA International
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: July 15, 2022
• Est. primary completion date: July 12, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Dietary Supplement:
• Carbohydrate 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
• Placebo capsule
The placebo is composed of a Hypromellose outer shell filled with extra virgin olive oil.

Locations

Country	Name	City	State
United States	doTERRA International	Pleasant Grove	Utah

Sponsors (1)

Lead Sponsor	Collaborator
doTERRA International

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Dose determination for Cohort 2	Dosage for cohort 2 will be determined	2 weeks
Primary	Glucose levels monitoring (Cohort 2)	Use of continuous glucose monitoring (CGM) to monitor interstitial glucose levels	2 months
Primary	Glycemic variability (Cohort 2)	Glycemic variability will be determined in healthy individuals.	2 months
Secondary	Glucose levels monitoring (Cohort 1)	Use of continuous glucose monitoring (CGM) to monitor interstitial glucose levels	2 weeks
Secondary	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
Secondary	Albumin (g/dL)	Item in comprehensive metabolic panel for safety assessment	2 weeks (Cohort 1), 2 months (Cohort 2)
Secondary	BUN (mg/dL)	Item in comprehensive metabolic panel for safety assessment	2 weeks (Cohort 1), 2 months (Cohort 2)
Secondary	Creatinine (mg/dL)	Item in comprehensive metabolic panel for safety assessment	2 weeks (Cohort 1), 2 months (Cohort 2)
Secondary	Alkaline phosphatase (U/L)	Item in comprehensive metabolic panel for safety assessment	2 weeks (Cohort 1), 2 months (Cohort 2)
Secondary	ALT (U/L)	Item in comprehensive metabolic panel for safety assessment	2 weeks (Cohort 1), 2 months (Cohort 2)
Secondary	AST (U/L)	Item in comprehensive metabolic panel for safety assessment	2 weeks (Cohort 1), 2 months (Cohort 2)
Secondary	Calcium (mg/dL)	Item in comprehensive metabolic panel for safety assessment	2 weeks, 2 months (Cohort 2)
Secondary	Carbon Dioxide (mmol/L)	Item in comprehensive metabolic panel for safety assessment	2 weeks (Cohort 1), 2 months (Cohort 2)
Secondary	Chloride (mmol/L)	Item in comprehensive metabolic panel for safety assessment	2 weeks (Cohort 1), 2 months (Cohort 2)
Secondary	Potassium (mmol/L)	Item in comprehensive metabolic panel for safety assessment	2 weeks (Cohort 1), 2 months (Cohort 2)
Secondary	Sodium (mmol/L)	Item in comprehensive metabolic panel for safety assessment	2 weeks (Cohort 1), 2 months (Cohort 2)
Secondary	Total bilirubin (mg/dL)	Item in comprehensive metabolic panel for safety assessment	2 weeks (Cohort 1), 2 months (Cohort 2)
Secondary	Total protein (g/dL)	Item in comprehensive metabolic panel for safety assessment	2 weeks (Cohort 1), 2 months (Cohort 2)
Secondary	Fasting insulin	Fasting insulin to determine changes, if any, to metabolism.	2 weeks (Cohort 1), 2 months (Cohort 2)
Secondary	Fasting glucose	Fasting glucose to determine changes, if any, to metabolism.	2 weeks (Cohort 1), 2 months (Cohort 2)
Secondary	Body weight	Determine whether body weight is affected by the consumption of the study product.	2 weeks (Cohort 1), 2 months (Cohort 2)
Secondary	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