Placebo-Controlled Clinical Nutrition Study of the Metabolic Effects of Food Product WBF-0011 in Type 2 Diabetes

NCT ID: NCT04047537

Last Updated: 2022-05-06

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-06
• Study Completion Date: 2020-05-30

Brief Summary

This 12 week placebo-controlled study evaluates the safety and impact of 2 different strengths of the medical food formulation WBF-0011.

Detailed Description

The medical food formulations being tested in this study contain butyrate-producing organisms plus a microbial strain that contributes to the integrity of the colonic mucin barrier. The microbes have been fully characterized, certified as Generally Recognized As Safe (GRAS) and manufactured to Good Manufacturing Practice (GMP) standards using excipients that are also GRAS qualified.

Subjects will receive their randomized formulation twice a day for 12 weeks.The target population will be patients with Type 2 Diabetes who are not treated with anti-diabetic agents or are treated with metformin alone.

Conditions

Type 2 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

Experimental: WBF-0011

2 capsules/day (one in the morning and one in the evening), taken with meal for 12 weeks

Group Type: OTHER

Medical Food Formulation 1

Intervention Type: OTHER

WBF-0011

Experimental: WBF-0011 (0.2X concentration)

2 capsules/day (one in the morning and one in the evening), taken with meal for 12 weeks

Group Type: OTHER

Medical Food Formulation 2

Intervention Type: OTHER

WBF-0011 (0.2X concentration)

Placebo

2 capsules/day (one in the morning and one in the evening), taken with meal for 12 weeks

Group Type: OTHER

Placebo

Intervention Type: OTHER

Placebo Capsules identical to those containing Formulation 1 and 2

Interventions

Medical Food Formulation 1

WBF-0011

Intervention Type: OTHER

Medical Food Formulation 2

WBF-0011 (0.2X concentration)

Intervention Type: OTHER

Placebo

Placebo Capsules identical to those containing Formulation 1 and 2

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Be able to give written informed consent
• Have type 2 diabetes treated with diet and exercise alone or in combination with metformin
• If treated with metformin, must have been on a stable dose of the drug for a minimum of 3 months with a stable A1c value
• If treated with diet and exercise alone, must have A1c value ≥6.5%
• If treated with diet and exercise + metformin, must have a stable A1c between 7.0% and 8.5% for at least 3 months
• BMI >25 but <45
• If female, must meet all the following criteria:

1. Not pregnant or breastfeeding

2. If of childbearing potential (including peri-menopausal women who have had a menstrual period within one year) must practice and be willing to continue to practice appropriate birth control during the entire duration of the study

• Must be able to communicate with the investigator, and understand and comply with protocol requirements

Exclusion Criteria

• Subjects who have received an antibiotic, antifungal, antiparasitic, or antiviral treatment within 30 days prior to study entry
• Subjects who plan to use antibiotic, antifungal, antiparasitic, or antiviral treatment during the study
• Subjects using a proton pump inhibitor must be on a consistent dose that will be maintained throughout the study period
• Present use of probiotics/nutritional supplements. (Note: The use of replacement doses of Vitamin D, calcium supplements, and a single daily multi-vitamin tablet is allowed)
• Subjects who have participated in a structured weight-loss program within the past 3 months
• Subjects who have changed body weight ≥3% within the past month
• Excess alcohol consumption; with an alcoholic drink defined as 284 ml of beer, lager, stout , 100 ml of wine or 35.5 ml spirits

1. Women: More than 11 standard drinks/week

2. Men: More than 17 standard drinks/week

• Subjects who have received an experimental drug within 30 days prior to study entry
• Hospitalization for any reason within the 3 months prior to study entry (Same day surgery centre visits/procedures allowed)
• Active GI disease
• History of any surgery on the gastrointestinal tract except appendectomy and cholecystectomy
• Cystic fibrosis
• Significant renal Impairment defined as estimated Glomerular Filtration Rate <45 ml/min
• Subjects receiving systemic corticosteroid therapy
• Subjects receiving Immunosuppression therapy
• Subjects with any condition that the investigator deems as a sound reason for disqualification from enrollment into the study

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pendulum Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Orville Kolterman, MD

Role: STUDY_DIRECTOR

Whole Biome

Locations

Atlantia Food Clinical Trials, 1st Floor, Block C, Heron House, Blackpool Retail Park

Cork, , Ireland

Countries

Ireland

Other Identifiers

AFCRO-104

Identifier Type: -

Identifier Source: org_study_id