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

Completed · Not applicable · Has a placebo group

Conditions studied: Healthy

In brief

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

Key facts

Study ID

NCT05832463

Run by

dōTERRA International

People needed

43

Starts

2021-05-14

Expected to finish

2022-07-15

Last updated by the study team

2023-04-27

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• doTERRA International — Pleasant Grove, Utah, United States

Full record on ClinicalTrials.gov

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