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History of Changes for Study: NCT03893422
Exploratory Placebo-Controlled Study of the Metabolic Effects of Two Medical Foods in Type 2 Diabetes
Latest version (submitted February 25, 2020) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 March 25, 2019 None (earliest Version on record)
2 February 25, 2020 Study Identification, Study Status
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Study NCT03893422
Submitted Date:  March 25, 2019 (v1)

Open or close this module Study Identification
Unique Protocol ID: WB201-202
Brief Title: Exploratory Placebo-Controlled Study of the Metabolic Effects of Two Medical Foods in Type 2 Diabetes
Official Title: An Exploratory Placebo-Controlled Study to Evaluate the Metabolic Effects of Two Medical Food Products in Subjects With Type 2 Diabetes Treated With Diet and Exercise Alone or in Combination With Metformin ± Sulfonylurea
Secondary IDs:
Open or close this module Study Status
Record Verification: March 2019
Overall Status: Completed
Study Start: October 22, 2017
Primary Completion: August 16, 2018 [Actual]
Study Completion: September 14, 2018 [Actual]
First Submitted: March 13, 2019
First Submitted that
Met QC Criteria:
March 25, 2019
First Posted: March 28, 2019 [Actual]
Last Update Submitted that
Met QC Criteria:
March 25, 2019
Last Update Posted: March 28, 2019 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Pendulum Therapeutics
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module Study Description
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)..
Detailed Description:

Targeting the microbiome for treating metabolic syndrome has been gaining traction with multiple population studies demonstrating a difference between healthy individuals and patients with metabolic syndrome. Whole Biome has identified and created two medical food formulations (MFFs) aimed at improving metabolic syndrome via two mechanisms of action targeting the microbiome: (1) increasing butyrate production and (2) increasing mucin regulation.

This randomized, parallel-group, placebo-controlled, double-blinded study assesses the safety and metabolic effects of 2 MFFs on glucose control and the generalized inflammatory state associated with Type 2 Diabetes. The microbes have been fully characterized, certified as Generally Recognized As Safe (GRAS) and manufactured to Good Manufacturing Practice (GMP) standards. The target population was patients with Type 2 Diabetes who either had not been treated with antidiabetic agents or treated with metformin +/- a sulfonylurea. Subjects were randomized in a balanced manner to receive capsules containing placebo, WBF10 or WBF11.

Open or close this module Conditions
Conditions: Type 2 Diabetes Mellitus
Keywords: glucose control
inflammation
safety
microbiome
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Other
Study Phase: Not Applicable
Interventional Study Model: Parallel Assignment
Balanced randomization across 3 arms: formulation WB-010, formulation WB-011 and placebo
Number of Arms: 3
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 76 [Actual]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: WB-010
3 capsules administered twice daily with morning and evening meal for 12 weeks
WB-010
Medical food formulation
Experimental: WB-011
3 capsules administered twice daily with morning and evening meal for 12 weeks
WB-011
WB-011 medical food product
Placebo Comparator: Placebo
3 capsules administered twice daily with morning and evening meal for 12 weeks
Placebo
Placebo Capsules identical to those containing WB-010 and WB-011.
Open or close this module Outcome Measures
Primary Outcome Measures:
1. 3-hour plasma glucose AUC
[ Time Frame: From Baseline to Week 12 ]

Change in area under plasma glucose concentration versus time curve (AUC) during standardized 3-hour Meal Tolerance Test
2. CRP
[ Time Frame: From Baseline to Week 12 ]

Change in c-reactive protein concentration
Secondary Outcome Measures:
1. Incremental glucose AUC
[ Time Frame: From Baseline to Week 12 ]

Change in area under plasma glucose concentration versus time curve (AUC) above the fasting plasma glucose level during standardized 3-hour Meal Tolerance Test
2. Hemoglobin A1c
[ Time Frame: From Baseline to Week 4 and Week 12 ]

Change in A1c
3. Fasting plasma glucose concentration
[ Time Frame: From Baseline to Weeks 4, 8 and 12 ]

Change in fasting plasma glucose concentration
4. Fasting plasma insulin concentration
[ Time Frame: Baseline to Weeks 4, 8 and 12 ]

Change in fasting plasma insulin concentration
5. Plasma insulin AUC
[ Time Frame: From Baseline to Week 12 ]

Change in area under plasma insulin concentration versus time curve (AUC) during standardized 3-hour Meal Tolerance Test
6. Homeostatic Model Assessment (HOMA) of Insulin Resistance (IR)
[ Time Frame: From Baseline to Week 12 ]

Change in HOMA-IR
7. Matsuda index
[ Time Frame: From Baseline to Week 12 ]

Change in Matsuda index
8. Fasting Lipid Panel
[ Time Frame: From Baseline to Week 12 ]

Change in fasting serum concentrations of total cholesterol, LDL cholesterol, HDL cholesterol and triglycerides
9. Inflammatory markers
[ Time Frame: From Baseline to Week 12 ]

Change in concentrations of interleukin-6, interleukin-10, tumor growth factor-α and T-cell growth factor-beta
10. Body weight in kilograms
[ Time Frame: From Baseline to Weeks 2, 4, 8 and 12 ]

Change in body weight in kilograms
11. Body Mass Index (BMI)
[ Time Frame: At Baseline ]

BMI = weight in kg/m2
12. Waist Circumference
[ Time Frame: From Baseline to Weeks 2, 4, 8 and 12 ]

Change in Waist Circumference
13. Fecal Microbiome Profile
[ Time Frame: From Baseline to Week 12 ]

Change in Fecal Microbiome Profile assessed by DNA sequencing
14. Adverse Events
[ Time Frame: From Baseline to Week 12 ]

Number of participants with adverse events related to therapy
15. Laboratory (Chemistry panel + CBC) Values
[ Time Frame: From Baseline to Week 12 ]

Number of Participants With Abnormal Laboratory Values Related to Therapy
16. Hospital Anxiety and Depression Scale
[ Time Frame: From Baseline to Week 12 ]

Subjects respond to 14 questions; 7 anxiety focused and 7 depression focused. Responses of "not at all", "not much", "sometimes" and "definitely" are translated to a numerical score of 0 to 4 respectively. For 2 of the depression related questions, the scoring scale is reversed. The individual numerical scores are added to provide an overall score which is interpreted as follows: 0 to 7 graded a non-case, 8 to 10 graded a borderline case and 11+ graded a case. An increase in the overall numerical score from baseline to Week 12 represents worsening and a decrease in the numerical score from baseline to Week 12 represents improvement.
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 75 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)
  • Active GI disease
  • Gastrointestinal tract surgery (appendectomy and cholecystectomy allowed)
  • Cystic fibrosis
  • Any condition deemed by the investigator to disqualify subject
Open or close this module Contacts/Locations
Study Officials: Orville G Kolterman, MD
Principal Investigator
Pendulum Therapeutics
Locations: United States, California
Science 37
Torrance, California, United States, 90505
Orange County Research Center
Tustin, California, United States, 92780
United States, Ohio
Northside Medical Center
Youngstown, Ohio, United States, 44505
United States, South Carolina
Coastal Carolina Research Center
Mount Pleasant, South Carolina, United States, 29464
United States, Texas
Juno Research, LLC
Houston, Texas, United States, 77074
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Links:
Available IPD/Information:

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U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services