Status:
UNKNOWN
Effects on Glycemic Control of WBF-0031 in Subjects With Abnormal Glucose Tolerance
Lead Sponsor:
Eden Miller
Collaborating Sponsors:
Pendulum Therapeutics
Conditions:
Abnormal Glucose Tolerance
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
Evaluation of the safety and effects on glycemic control of medical food formulation WBF-0031 in subjects with abnormal glucose control.
Detailed Description
The current study aims to investigate if altering the microbiome though Pendulum Glucose Control supplementation can have implications aimed at maintaining normal blood glucose levels that are critica...
Eligibility Criteria
Inclusion
- Between 18-80 years of age
- BMI \< 45 kg/m2
- Eligible based on a recent (within the past year) blood test meeting one of these specifications:
- Fasting glucose of 100 to 125 mg/dl
- Plasma glucose measured 2 hours after a 75-gram glucose load of 140 to 199 mg/dl
- A1c of 5.7 to 6.4%
- Clinically diagnosed gestational diabetes mellitus (GDM) during a previous pregnancy (may be self-reported)
- Willing to comply with study requirements
- Provide written informed consent
Exclusion
- Known diagnosis of diabetes / taking any medication for the treatment of diabetes including the off-label use of a GLP-1 receptor agonist, SGLT-2, or metformin) within the last 3 months for weight loss.
- Active participation in another lifestyle or behavior change education or research program (DPP or weight loss program)
- Current treatment with systemic corticosteroids (topical and nasal steroids are allowed)
- Subjects who have received an antibiotic, antifungal, antiparasitic, or antiviral treatment within 30 days prior to study entry
- Pregnant women
Key Trial Info
Start Date :
June 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2021
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04490460
Start Date
June 1 2020
End Date
February 28 2021
Last Update
July 29 2020
Active Locations (1)
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1
Diabetes and Obesity Care
Bend, Oregon, United States, 97703