Placebo-Controlled Clinical Nutrition Study of the Safety and Metabolic Effects of Two Medical Foods in Type 2 Diabetes

NCT03893422 | Completed

• 1 other identifier: WB201-202
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 5

Brief Summary

This 16 week placebo-controlled study evaluates the safety and impact of two medical food study products, WBF10 and WBF11, consisting of commensal microbes. The primary endpoints were safety, glucose AUC during meal tolerance test and C reactive protein (CRP)..

Conditions

Type 2 Diabetes Mellitus

Keywords

glucose control; inflammation; safety; microbiome

Outcome Measures

Primary Outcomes (2)

• 3-hour plasma glucose AUC

  Change in area under plasma glucose concentration versus time curve (AUC) during standardized 3-hour Meal Tolerance Test

  From Baseline to Week 12

• CRP

  Change in c-reactive protein concentration

  From Baseline to Week 12

Secondary Outcomes (16)

• Incremental glucose AUC

  From Baseline to Week 12

• Hemoglobin A1c

  From Baseline to Week 4 and Week 12

• Fasting plasma glucose concentration

  From Baseline to Weeks 4, 8 and 12

• Fasting plasma insulin concentration

  Baseline to Weeks 4, 8 and 12

• Plasma insulin AUC

  From Baseline to Week 12

Study Arms (3)

WB-010

EXPERIMENTAL

3 capsules administered twice daily with morning and evening meal for 12 weeks

Other: WB-010

WB-011

EXPERIMENTAL

3 capsules administered twice daily with morning and evening meal for 12 weeks

Other: WB-011

Placebo

PLACEBO COMPARATOR

3 capsules administered twice daily with morning and evening meal for 12 weeks

Other: Placebo

Interventions

WB-010 OTHER

Medical food formulation

WB-010

WB-011 OTHER

WB-011 medical food product

WB-011

Placebo OTHER

Placebo Capsules identical to those containing WB-010 and WB-011.

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 2 diabetes treated with diet and exercise alone or in combination with metformin and/or sulfonylurea
• If treated with metformin and/or sulfonylurea, must have been on a stable dose of the drug(s) for a minimum of 3 months with a stable A1c value
• If treated with diet and exercise alone, must have one of the following:
• Documented fasting plasma glucose \>126 mg/dL
• A1c value ≥6.8%
• If treated with diet and exercise + metformin and/or sulfonylurea, must have a stable A1c between 6.8% and 11.0% for 3 months prior study entry
• BMI \>25 but \<45 and weight stable within +/- 5% over past 3 months
• If female, must meet all the following criteria:
• Not pregnant or breastfeeding
• If of childbearing potential (including peri-menopausal women with menstruation during past year) must practice and be willing to continue appropriate birth control during the entire duration of the study
• Have a home freezer available for immediate freezing of stool samples
• Able to read, understand, and sign the informed consent form (ICF) and HIPAA authorization when applicable,
• Able to communicate with the investigator, and understand and comply with protocol requirements

You may not qualify if:

• Use of antibiotic, antifungal, antiparasitic, or antiviral therapy within 30 days prior to study entry
• Planned use or antibiotic, antifungal, antiparasitic, or antiviral treatment during the study period
• Subjects using a proton pump inhibitor must be on a stable dose that will be maintained throughout the study period
• Present use of probiotics/nutritional supplements. (Note: Use of replacement doses of Vitamin D, calcium supplements, and a single daily multi-vitamin tablet allowed)
• Participation in a structured weight-loss program within the past 2 months
• Change in body weight ≥5% within the past month
• Excess alcohol consumption; with an alcoholic drink defined as 12 fluid ounces of beer (5% alcohol), 5 fluid ounces of wine (12% alcohol) or 1.5 fluid ounces of 80 proof distilled spirits
• Women: More than 2 alcoholic drinks/day or more than 7 drinks/week
• Men: More than 3 alcoholic drinks/day or more than 10 drinks/week
• Travel outside United States within 30 days of study entry
• Planned travel outside United States during study period
• Use of an experimental drug within 30 days prior to study entry
• Known milk, peanut, tree nut, wheat, soy or shellfish allergy
• Diagnosis of a sexually transmitted disease including, but not limited to, HIV, syphilis, herpes, gonorrhea, hepatitis A, hepatitis B, and hepatitis C
• Hospitalization during last 3 months (Same day surgery center procedures allowed)

Sponsors & Collaborators

• Pendulum Therapeutics: lead

Study Sites (5)

Science 37

Torrance, California, 90505, United States

Location

Orange County Research Center

Tustin, California, 92780, United States

Location

Northside Medical Center

Youngstown, Ohio, 44505, United States

Location

Coastal Carolina Research Center

Mt. Pleasant, South Carolina, 29464, United States

Location

Juno Research, LLC

Houston, Texas, 77074, United States

Location

Related Publications (1)

• Perraudeau F, McMurdie P, Bullard J, Cheng A, Cutcliffe C, Deo A, Eid J, Gines J, Iyer M, Justice N, Loo WT, Nemchek M, Schicklberger M, Souza M, Stoneburner B, Tyagi S, Kolterman O. Improvements to postprandial glucose control in subjects with type 2 diabetes: a multicenter, double blind, randomized placebo-controlled trial of a novel probiotic formulation. BMJ Open Diabetes Res Care. 2020 Jul;8(1):e001319. doi: 10.1136/bmjdrc-2020-001319.

  PMID: 32675291 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Inflammation

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Orville G Kolterman, MD

  Pendulum Therapeutics

  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: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Balanced randomization across 3 arms: formulation WB-010, formulation WB-011 and placebo

Study Record Dates

• First Submitted: March 13, 2019
• First Posted: March 28, 2019
• Study Start: October 22, 2017
• Primary Completion: August 16, 2018
• Study Completion: September 14, 2018
• Last Updated: February 27, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)