Abnormal Glucose ToleranceNCT04490460
Effects on Glycemic Control of WBF-0031 in Subjects With Abnormal Glucose Tolerance
A study testing WBF-0031 in people with Abnormal Glucose Tolerance, run by Eden Miller at 1 site in United States.
Trial summary
Evaluation of the safety and effects on glycemic control of medical food formulation WBF-0031 in subjects with abnormal glucose control. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Abnormal Glucose Tolerance
- What is being tested?
- WBF-0031
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2020to 28 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Between 18-80 years of age
- BMI < 45 kg/m2
- Eligible based on a recent (within the past year) blood test meeting one of these specifications:
- Fasting glucose of 100 to 125 mg/dl
- Plasma glucose measured 2 hours after a 75-gram glucose load of 140 to 199 mg/dl
- A1c of 5.7 to 6.4%
Show all 9Show fewer
- Clinically diagnosed gestational diabetes mellitus (GDM) during a previous pregnancy (may be self-reported)
- Willing to comply with study requirements
- Provide written informed consent
Who cannot join
- Known diagnosis of diabetes / taking any medication for the treatment of diabetes including the off-label use of a GLP-1 receptor agonist, SGLT-2, or metformin) within the last 3 months for weight loss.
- Active participation in another lifestyle or behavior change education or research program (DPP or weight loss program)
- Current treatment with systemic corticosteroids (topical and nasal steroids are allowed)
- Subjects who have received an antibiotic, antifungal, antiparasitic, or antiviral treatment within 30 days prior to study entry
- Pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Safety and Effects on Glycemic Control of Medical Food Formulation WBF-0031 in Subjects With Abnormal Glucose Tolerance
Evaluation of the safety and effects on glycemic control of medical food formulation WBF-0031 in subjects with abnormal glucose control.
Read the detailed description
The current study aims to investigate if altering the microbiome though Pendulum Glucose Control supplementation can have implications aimed at maintaining normal blood glucose levels that are critical for preventing diabetes and its metabolic complications. The experimental design consists of two-12 week treatment periods in subjects with prediabetes, as defined by the National Diabetes Prevention Program (DPP) criteria.
The first study period of 12 weeks will be double-blinded, placebo-controlled. The Pendulum Glucose control and placebo will be in a capsule form and identical in appearance, and dispensed to each participant according to the randomization schedule in the first 12 weeks. All subjects will receive the active product (Pendulum Glucose Control) in the second, subsequent 12 week period.
Fasting total cholesterol, triglycerides, LDL, and HDL cholesterol, Fasting insulin and Glucose, High sensitivity C Reactive Protein (hsCRP), Chemistry 14, and HbA1c will be obtained at baseline, and during first and second study period, as well as vital signs of weight, BP, and waist circumference.
In addition, CGM (Abbott System Freestyle Libre Pro) data collection will be done three times during the study as noted in Schedule of Events. Baseline Blinded CGM will be performed for approximately 14 days prior to starting the intervention with Pendulum Glucose Control. Second Blinded CGM period for approximately 14 days will occur mid-way through the intervention (weeks 5 and 6) and a third period of Blinded CGM wear will occur during the last 2 weeks of the intervention (weeks 11 and 12). During the Baseline, study period one and period 2 a mixed meal tolerance consisting of 2 Boost Shakes will be given on day 5 of each sensor wear.
At the completion of the study, analysis of the vital signs, laboratory values, CGM data for average glucose, standard deviation, TIR (time in range), as well as glycemic results of MMT for each time interval; baseline, study period one, and two.
- Conditions
- Abnormal Glucose Tolerance
- Being tested
- WBF-0031
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WBF-0031Dietary supplement
Medical food formulation WBF-0031
| Study group | Role | What they receive |
|---|---|---|
| First 12 Weeks | Placebo comparator | 1 capsule administered twice daily with morning and evening meal for 12 weeks. Double blind 50% Placebo capsules identical to those containing WB-0031 and 50% WB-0031 Receives: Dietary Supplement: WBF-0031 |
| Second 12 Weeks | Active comparator | 1 capsule administered twice daily with morning and evening meal for 12 weeks. All participants receiving WB-0031. Receives: Dietary Supplement: WBF-0031 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Assessment of Adverse Events
Safety assessed via spontaneous adverse events reported during the study period and changes in chemistry 14 panel
Measured: 30 weeks
Time spent in target blood glucose
Difference in daily glucose levels as measured by the amount of time spent in target blood glucose for each CGM wear period. Adjustable glucose thresholds will be set as follows:<60 mg/dL, <70 mg/dL, >140 mg/dL, >180 mg/dL and >240 mg/dL. The percent of values above, below, and between these points will be calculated.
Measured: Three 14 day intervals
Secondary outcomes (4)
Total Glucose Area Under the Curve (AUC) from baseline
Twelve and 24 week difference from baseline in total Glucose AUC during a standard Meal Tolerance Test (MMT)
Measured: 24 weeks
Incremental Glucose Area Under the Curve (AUC) from baseline
Twelve and 24 week difference from baseline in incremental Glucose AUC during a standard Meal Tolerance Test (MMT)
Measured: 24 weeks
Glucose peaks
Mean and standard deviation of post-prandial peak glucose and time to peak for each meal
Measured: 30 weeks
A1c
Improvement in A1c measured as a change in A1c levels from baseline at 12 and 24 weeks. Subjects enrolled in the study will have fasting A1c measurements at the time of enrollment and weeks, 0, 12 and 24 weeks.
Measured: Week 0, Week 12, Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2020
- Study start1 Jun 2020
- Primary completion1 Feb 2021 (estimated)
- Study completion28 Feb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abnormal Glucose ToleranceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Balanced randomization first arm, formulation WBF-0031 and placebo. Second arm all subjects formulation WBF-0031.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eden Miller
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pendulum Therapeutics
- Responsible party
- Sponsor-investigator, Eden Miller, Diabetes and Obesity Care
- Investigators
- Eden Miller, D.O., Principal investigator, Diabetes and Obesity Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04490460
- Sponsor's protocol ID
- WB01-501
- Status last verified
- Jul 2020
- First submitted
- 13 Jul 2020
- Last updated
- 29 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety and Effects on Glycemic Control of Medical Food Formulation WBF-0031 in Subjects With Abnormal Glucose Tolerance
- ClinicalTrials.gov ID
- NCT04490460
- Acronym / sponsor ID
- WB01-501
- Conditions
- Abnormal Glucose Tolerance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Eden MillerIndustry (pharma, biotech, devices)
- Collaborators
- Pendulum Therapeutics
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 1 Feb 2021 (estimated)
- Study completion
- 28 Feb 2021 (estimated)
- First posted
- 29 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluation of the safety and effects on glycemic control of medical food formulation WBF-0031 in subjects with abnormal glucose control.
Detailed description
The current study aims to investigate if altering the microbiome though Pendulum Glucose Control supplementation can have implications aimed at maintaining normal blood glucose levels that are critical for preventing diabetes and its metabolic complications. The experimental design consists of two-12 week treatment periods in subjects with prediabetes, as defined by the National Diabetes Prevention Program (DPP) criteria.
The first study period of 12 weeks will be double-blinded, placebo-controlled. The Pendulum Glucose control and placebo will be in a capsule form and identical in appearance, and dispensed to each participant according to the randomization schedule in the first 12 weeks. All subjects will receive the active product (Pendulum Glucose Control) in the second, subsequent 12 week period.
Fasting total cholesterol, triglycerides, LDL, and HDL cholesterol, Fasting insulin and Glucose, High sensitivity C Reactive Protein (hsCRP), Chemistry 14, and HbA1c will be obtained at baseline, and during first and second study period, as well as vital signs of weight, BP, and waist circumference.
In addition, CGM (Abbott System Freestyle Libre Pro) data collection will be done three times during the study as noted in Schedule of Events. Baseline Blinded CGM will be performed for approximately 14 days prior to starting the intervention with Pendulum Glucose Control. Second Blinded CGM period for approximately 14 days will occur mid-way through the intervention (weeks 5 and 6) and a third period of Blinded CGM wear will occur during the last 2 weeks of the intervention (weeks 11 and 12). During the Baseline, study period one and period 2 a mixed meal tolerance consisting of 2 Boost Shakes will be given on day 5 of each sensor wear.
At the completion of the study, analysis of the vital signs, laboratory values, CGM data for average glucose, standard deviation, TIR (time in range), as well as glycemic results of MMT for each time interval; baseline, study period one, and two.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Balanced randomization first arm, formulation WBF-0031 and placebo. Second arm all subjects formulation WBF-0031.
| Arm | Type | Receives |
|---|---|---|
| First 12 Weeks | Placebo comparator | Dietary Supplement: WBF-00311 capsule administered twice daily with morning and evening meal for 12 weeks. Double blind 50% Placebo capsules identical to those containing WB-0031 and 50% WB-0031 |
| Second 12 Weeks | Active comparator | Dietary Supplement: WBF-00311 capsule administered twice daily with morning and evening meal for 12 weeks. All participants receiving WB-0031. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Between 18-80 years of age
- BMI < 45 kg/m2
- Eligible based on a recent (within the past year) blood test meeting one of these specifications:
- Willing to comply with study requirements
- Provide written informed consent
Key exclusion criteria (5 listed)
- Known diagnosis of diabetes / taking any medication for the treatment of diabetes including the off-label use of a GLP-1 receptor agonist, SGLT-2, or metformin) within the last 3 months for weight loss.
- Active participation in another lifestyle or behavior change education or research program (DPP or weight loss program)
- Current treatment with systemic corticosteroids (topical and nasal steroids are allowed)
- Subjects who have received an antibiotic, antifungal, antiparasitic, or antiviral treatment within 30 days prior to study entry
- Pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WBF-0031Medical food formulation WBF-0031 | Dietary supplement | First 12 Weeks, Second 12 Weeks |
Primary outcome
Safety Assessment of Adverse Events
Time frame: 30 weeks
Safety assessed via spontaneous adverse events reported during the study period and changes in chemistry 14 panel
Time spent in target blood glucose
Time frame: Three 14 day intervals
Difference in daily glucose levels as measured by the amount of time spent in target blood glucose for each CGM wear period. Adjustable glucose thresholds will be set as follows:<60 mg/dL, <70 mg/dL, >140 mg/dL, >180 mg/dL and >240 mg/dL. The percent of values above, below, and between these points will be calculated.
4 secondary outcomes
Total Glucose Area Under the Curve (AUC) from baseline
Time frame: 24 weeks
Incremental Glucose Area Under the Curve (AUC) from baseline
Time frame: 24 weeks
Glucose peaks
Time frame: 30 weeks
A1c
Time frame: Week 0, Week 12, Week 24
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2020.
- Individual participant dataSharing planned: No
Related trials for Abnormal Glucose Tolerance
Not yet recruitingPhase 2
Verapamil Effect in Cystic Fibrosis-related Dysglycemia
Cystic Fibrosis Related Diabetes, Cystic Fibrosis (CF)
RecruitingPhase 2
GLP-1 Agonist Therapy in Cystic Fibrosis-Related Glucose Intolerance
Cystic Fibrosis, Pancreatic Insufficiency
Not yet recruitingObservational study
Abnormal Glucose Tolerance in Allogeneic Hematopoietic Stem Cell Transplantation
ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION, Diabetes Mellitus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eden Miller, D.O. principal investigator
Diabetes and Obesity Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WBF-0031 in people with Abnormal Glucose Tolerance, run by Eden Miller at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety Assessment of Adverse Events (time frame: 30 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2020.