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

dōTERRA

Status: Completed

Conditions: Healthy

Treatments: Dietary Supplement: Placebo capsule; Dietary Supplement: Carbohydrate blocking supplement (CBS)

Study type: Interventional

Funder types: Industry

Identifiers

NCT05832463

DO-120043-CBS

Details and patient eligibility

About

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

Full 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.

Enrollment: 43 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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43 participants in 2 patient groups, including a placebo group

Experimental arm

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Carbohydrate blocking supplement (CBS)

Placebo arm

Placebo Comparator group

Description:

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.

Treatment:

Dietary Supplement: Placebo capsule