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

NCT ID: NCT05832463

Last Updated: 2023-04-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-14
• Study Completion Date: 2022-07-15

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Experimental arm

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.

Group Type: EXPERIMENTAL

Carbohydrate blocking supplement (CBS)

Intervention Type: 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 arm

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.

Group Type: PLACEBO_COMPARATOR

Placebo capsule

Intervention Type: DIETARY_SUPPLEMENT

The placebo is composed of a Hypromellose outer shell filled with extra virgin olive oil.

Interventions

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

Intervention Type: DIETARY_SUPPLEMENT

Placebo capsule

The placebo is composed of a Hypromellose outer shell filled with extra virgin olive oil.

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

dōTERRA International

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Russell Osguthorpe, MD

Role: PRINCIPAL_INVESTIGATOR

doTERRA International

Locations

doTERRA International

Pleasant Grove, Utah, United States

Countries

United States

Other Identifiers

DO-120043-CBS

Identifier Type: -

Identifier Source: org_study_id