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Trial record 1 of 1 for:    Whole Biome | Type 2 diabetes | California, United States | Adult, Older Adult
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Exploratory Placebo-Controlled Study of the 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 : March 28, 2019
Sponsor:
Information provided by (Responsible Party):
Whole Biome Inc.

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)..

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Other: WB-010 Other: WB-011 Other: Placebo Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 76 participants
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
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
Actual Study Start Date : October 22, 2017
Actual Primary Completion Date : August 16, 2018
Actual Study Completion Date : September 14, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: WB-010
3 capsules administered twice daily with morning and evening meal for 12 weeks
Other: WB-010
Medical food formulation

Experimental: WB-011
3 capsules administered twice daily with morning and evening meal for 12 weeks
Other: WB-011
WB-011 medical food product

Placebo Comparator: Placebo
3 capsules administered twice daily with morning and evening meal for 12 weeks
Other: Placebo
Placebo Capsules identical to those containing WB-010 and WB-011.




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.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03893422


Locations
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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
Sponsors and Collaborators
Whole Biome Inc.
Investigators
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Principal Investigator: Orville G Kolterman, MD Whole Biome Inc.

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Responsible Party: Whole Biome Inc.
ClinicalTrials.gov Identifier: NCT03893422     History of Changes
Other Study ID Numbers: WB201-202
First Posted: March 28, 2019    Key Record Dates
Last Update Posted: March 28, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Whole Biome Inc.:
glucose control
inflammation
safety
microbiome

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases