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

Primary Purpose

Type 2 Diabetes Mellitus

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
WB-010
WB-011
Placebo
Sponsored by
Pendulum Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Type 2 Diabetes Mellitus focused on measuring glucose control, inflammation, safety, microbiome

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Science 37
  • Orange County Research Center
  • Northside Medical Center
  • Coastal Carolina Research Center
  • Juno Research, LLC

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

WB-010

WB-011

Placebo

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Incremental glucose AUC
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
Change in A1c
Fasting plasma glucose concentration
Change in fasting plasma glucose concentration
Fasting plasma insulin concentration
Change in fasting plasma insulin concentration
Plasma insulin AUC
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)
Change in HOMA-IR
Matsuda index
Change in Matsuda index
Fasting Lipid Panel
Change in fasting serum concentrations of total cholesterol, LDL cholesterol, HDL cholesterol and triglycerides
Inflammatory markers
Change in concentrations of interleukin-6, interleukin-10, tumor growth factor-α and T-cell growth factor-beta
Body weight in kilograms
Change in body weight in kilograms
Body Mass Index (BMI)
BMI = weight in kg/m2
Waist Circumference
Change in Waist Circumference
Fecal Microbiome Profile
Change in Fecal Microbiome Profile assessed by DNA sequencing
Adverse Events
Number of participants with adverse events related to therapy
Laboratory (Chemistry panel + CBC) Values
Number of Participants With Abnormal Laboratory Values Related to Therapy
Hospital Anxiety and Depression Scale
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.

Full Information

First Posted
March 13, 2019
Last Updated
February 25, 2020
Sponsor
Pendulum Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT03893422
Brief Title
Placebo-Controlled Clinical Nutrition Study of the Safety and Metabolic Effects of Two Medical Foods in Type 2 Diabetes
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
October 22, 2017 (Actual)
Primary Completion Date
August 16, 2018 (Actual)
Study Completion Date
September 14, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pendulum Therapeutics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
glucose control, inflammation, safety, microbiome

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Balanced randomization across 3 arms: formulation WB-010, formulation WB-011 and placebo
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Study product was provided for each arm in identical capsules
Allocation
Randomized
Enrollment
76 (Actual)

8. Arms, Groups, and Interventions

Arm Title
WB-010
Arm Type
Experimental
Arm Description
3 capsules administered twice daily with morning and evening meal for 12 weeks
Arm Title
WB-011
Arm Type
Experimental
Arm Description
3 capsules administered twice daily with morning and evening meal for 12 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
3 capsules administered twice daily with morning and evening meal for 12 weeks
Intervention Type
Other
Intervention Name(s)
WB-010
Intervention Description
Medical food formulation
Intervention Type
Other
Intervention Name(s)
WB-011
Intervention Description
WB-011 medical food product
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo Capsules identical to those containing WB-010 and WB-011.
Primary Outcome Measure Information:
Title
3-hour plasma glucose AUC
Description
Change in area under plasma glucose concentration versus time curve (AUC) during standardized 3-hour Meal Tolerance Test
Time Frame
From Baseline to Week 12
Title
CRP
Description
Change in c-reactive protein concentration
Time Frame
From Baseline to Week 12
Secondary Outcome Measure Information:
Title
Incremental glucose AUC
Description
Change in area under plasma glucose concentration versus time curve (AUC) above the fasting plasma glucose level during standardized 3-hour Meal Tolerance Test
Time Frame
From Baseline to Week 12
Title
Hemoglobin A1c
Description
Change in A1c
Time Frame
From Baseline to Week 4 and Week 12
Title
Fasting plasma glucose concentration
Description
Change in fasting plasma glucose concentration
Time Frame
From Baseline to Weeks 4, 8 and 12
Title
Fasting plasma insulin concentration
Description
Change in fasting plasma insulin concentration
Time Frame
Baseline to Weeks 4, 8 and 12
Title
Plasma insulin AUC
Description
Change in area under plasma insulin concentration versus time curve (AUC) during standardized 3-hour Meal Tolerance Test
Time Frame
From Baseline to Week 12
Title
Homeostatic Model Assessment (HOMA) of Insulin Resistance (IR)
Description
Change in HOMA-IR
Time Frame
From Baseline to Week 12
Title
Matsuda index
Description
Change in Matsuda index
Time Frame
From Baseline to Week 12
Title
Fasting Lipid Panel
Description
Change in fasting serum concentrations of total cholesterol, LDL cholesterol, HDL cholesterol and triglycerides
Time Frame
From Baseline to Week 12
Title
Inflammatory markers
Description
Change in concentrations of interleukin-6, interleukin-10, tumor growth factor-α and T-cell growth factor-beta
Time Frame
From Baseline to Week 12
Title
Body weight in kilograms
Description
Change in body weight in kilograms
Time Frame
From Baseline to Weeks 2, 4, 8 and 12
Title
Body Mass Index (BMI)
Description
BMI = weight in kg/m2
Time Frame
At Baseline
Title
Waist Circumference
Description
Change in Waist Circumference
Time Frame
From Baseline to Weeks 2, 4, 8 and 12
Title
Fecal Microbiome Profile
Description
Change in Fecal Microbiome Profile assessed by DNA sequencing
Time Frame
From Baseline to Week 12
Title
Adverse Events
Description
Number of participants with adverse events related to therapy
Time Frame
From Baseline to Week 12
Title
Laboratory (Chemistry panel + CBC) Values
Description
Number of Participants With Abnormal Laboratory Values Related to Therapy
Time Frame
From Baseline to Week 12
Title
Hospital Anxiety and Depression Scale
Description
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.
Time Frame
From Baseline to Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Orville G Kolterman, MD
Organizational Affiliation
Pendulum Therapeutics
Official's Role
Principal Investigator
Facility Information:
Facility Name
Science 37
City
Torrance
State/Province
California
ZIP/Postal Code
90505
Country
United States
Facility Name
Orange County Research Center
City
Tustin
State/Province
California
ZIP/Postal Code
92780
Country
United States
Facility Name
Northside Medical Center
City
Youngstown
State/Province
Ohio
ZIP/Postal Code
44505
Country
United States
Facility Name
Coastal Carolina Research Center
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
Juno Research, LLC
City
Houston
State/Province
Texas
ZIP/Postal Code
77074
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32675291
Citation
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.
Results Reference
derived

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

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