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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03893422
Recruitment Status : Completed
First Posted : March 28, 2019
Last Update Posted : February 27, 2020
Sponsor:
Information provided by (Responsible Party):
Pendulum Therapeutics

Tracking Information
First Submitted Date  ICMJE March 13, 2019
First Posted Date  ICMJE March 28, 2019
Last Update Posted Date February 27, 2020
Actual Study Start Date  ICMJE October 22, 2017
Actual Primary Completion Date August 16, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 25, 2019)
  • 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
  • CRP [ Time Frame: From Baseline to Week 12 ]
    Change in c-reactive protein concentration
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 25, 2019)
  • 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
  • Hemoglobin A1c [ Time Frame: From Baseline to Week 4 and Week 12 ]
    Change in A1c
  • Fasting plasma glucose concentration [ Time Frame: From Baseline to Weeks 4, 8 and 12 ]
    Change in fasting plasma glucose concentration
  • Fasting plasma insulin concentration [ Time Frame: Baseline to Weeks 4, 8 and 12 ]
    Change in fasting plasma insulin concentration
  • 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
  • Homeostatic Model Assessment (HOMA) of Insulin Resistance (IR) [ Time Frame: From Baseline to Week 12 ]
    Change in HOMA-IR
  • Matsuda index [ Time Frame: From Baseline to Week 12 ]
    Change in Matsuda index
  • Fasting Lipid Panel [ Time Frame: From Baseline to Week 12 ]
    Change in fasting serum concentrations of total cholesterol, LDL cholesterol, HDL cholesterol and triglycerides
  • 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
  • Body weight in kilograms [ Time Frame: From Baseline to Weeks 2, 4, 8 and 12 ]
    Change in body weight in kilograms
  • Body Mass Index (BMI) [ Time Frame: At Baseline ]
    BMI = weight in kg/m2
  • Waist Circumference [ Time Frame: From Baseline to Weeks 2, 4, 8 and 12 ]
    Change in Waist Circumference
  • Fecal Microbiome Profile [ Time Frame: From Baseline to Week 12 ]
    Change in Fecal Microbiome Profile assessed by DNA sequencing
  • Adverse Events [ Time Frame: From Baseline to Week 12 ]
    Number of participants with adverse events related to therapy
  • Laboratory (Chemistry panel + CBC) Values [ Time Frame: From Baseline to Week 12 ]
    Number of Participants With Abnormal Laboratory Values Related to Therapy
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Placebo-Controlled Clinical Nutrition Study of the Safety and Metabolic Effects of Two Medical Foods in Type 2 Diabetes
Official Title  ICMJE An Placebo-Controlled Clinical Nutrition 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Balanced randomization across 3 arms: formulation WB-010, formulation WB-011 and placebo
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Study product was provided for each arm in identical capsules
Primary Purpose: Other
Condition  ICMJE Type 2 Diabetes Mellitus
Intervention  ICMJE
  • Other: WB-010
    Medical food formulation
  • Other: WB-011
    WB-011 medical food product
  • Other: Placebo
    Placebo Capsules identical to those containing WB-010 and WB-011.
Study Arms  ICMJE
  • Experimental: WB-010
    3 capsules administered twice daily with morning and evening meal for 12 weeks
    Intervention: Other: WB-010
  • Experimental: WB-011
    3 capsules administered twice daily with morning and evening meal for 12 weeks
    Intervention: Other: WB-011
  • Placebo Comparator: Placebo
    3 capsules administered twice daily with morning and evening meal for 12 weeks
    Intervention: Other: Placebo
Publications * 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). pii: e001319. doi: 10.1136/bmjdrc-2020-001319.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 25, 2019)
76
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 14, 2018
Actual Primary Completion Date August 16, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03893422
Other Study ID Numbers  ICMJE WB201-202
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Pendulum Therapeutics
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Pendulum Therapeutics
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Orville G Kolterman, MD Pendulum Therapeutics
PRS Account Pendulum Therapeutics
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP