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

NCT04047537 | Terminated

• 1 other identifier: AFCRO-104
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Hemoglobin A1c

  Change from baseline to Week 12 in each of the treatment groups as compared to placebo in A1c levels

  From Baseline to Week 12

Secondary Outcomes (9)

• 3-hour blood glucose Area Under the Curve (AUC)

  Baseline to Weeks 2, 6, 9 and 12

• 3-hour plasma glucose AUC

  Baseline to Weeks 2, 6, 9 and 12

• 3-hour blood glucose AUC

  Baseline to Weeks 1, 3, 4, 5, 7, 8, 10, and 11.

• 24-hour CGM

  From Baseline to Week 12

• Fasting Lipid Panel

  From Baseline to Week 12

Study Arms (3)

Experimental: WBF-0011

OTHER

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

Other: Medical Food Formulation 1

Experimental: WBF-0011 (0.2X concentration)

OTHER

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

Other: Medical Food Formulation 2

Placebo

OTHER

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

Other: Placebo

Interventions

Medical Food Formulation 1 OTHER

WBF-0011

Experimental: WBF-0011

Medical Food Formulation 2 OTHER

WBF-0011 (0.2X concentration)

Experimental: WBF-0011 (0.2X concentration)

Placebo OTHER

Placebo Capsules identical to those containing Formulation 1 and 2

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Not pregnant or breastfeeding
• 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

You may not qualify if:

• 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
• Women: More than 11 standard drinks/week
• 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

Sponsors & Collaborators

• Pendulum Therapeutics: lead

Study Sites (1)

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

Cork, Ireland

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Orville Kolterman, MD

  Whole Biome

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2019
• First Posted: August 6, 2019
• Study Start: August 6, 2019
• Primary Completion: April 15, 2020
• Study Completion: May 30, 2020
• Last Updated: May 6, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)