Effects on Glycemic Control of WBF-0031 in Subjects With Abnormal Glucose Tolerance

NCT04490460 | Unknown DMC

• 1 other identifier: WB01-501
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluation of the safety and effects on glycemic control of medical food formulation WBF-0031 in subjects with abnormal glucose control.

Conditions

Abnormal Glucose Tolerance

Outcome Measures

Primary Outcomes (2)

• Safety Assessment of Adverse Events

  Safety assessed via spontaneous adverse events reported during the study period and changes in chemistry 14 panel

  30 weeks

• Time spent in target blood glucose

  Difference in daily glucose levels as measured by the amount of time spent in target blood glucose for each CGM wear period. Adjustable glucose thresholds will be set as follows:\<60 mg/dL, \<70 mg/dL, \>140 mg/dL, \>180 mg/dL and \>240 mg/dL. The percent of values above, below, and between these points will be calculated.

  Three 14 day intervals

Secondary Outcomes (4)

• Total Glucose Area Under the Curve (AUC) from baseline

  24 weeks

• Incremental Glucose Area Under the Curve (AUC) from baseline

  24 weeks

• Glucose peaks

  30 weeks

• A1c

  Week 0, Week 12, Week 24

Other Outcomes (1)

• Questionnaire

  Week 0, Week 12, Week 24

Study Arms (2)

First 12 Weeks

PLACEBO COMPARATOR

1 capsule administered twice daily with morning and evening meal for 12 weeks. Double blind 50% Placebo capsules identical to those containing WB-0031 and 50% WB-0031

Dietary Supplement: WBF-0031

Second 12 Weeks

ACTIVE COMPARATOR

1 capsule administered twice daily with morning and evening meal for 12 weeks. All participants receiving WB-0031.

Dietary Supplement: WBF-0031

Interventions

WBF-0031 DIETARY_SUPPLEMENT

Medical food formulation WBF-0031

First 12 Weeks; Second 12 Weeks

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eden Miller: lead
• Pendulum Therapeutics: collaborator

Study Sites (1)

Diabetes and Obesity Care

Bend, Oregon, 97703, United States

Location

Study Officials

• Eden Miller, D.O.

  Diabetes and Obesity Care

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Study product was provided for each arm in identical capsules.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Balanced randomization first arm, formulation WBF-0031 and placebo. Second arm all subjects formulation WBF-0031.

Study Record Dates

• First Submitted: July 13, 2020
• First Posted: July 29, 2020
• Study Start: June 1, 2020
• Primary Completion: February 1, 2021
• Study Completion: February 28, 2021
• Last Updated: July 29, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)