Evaluation of the Safety and Effects on Glycemic Control of Medical Food Formulation WBF-0031 in Subjects With Abnormal Glucose Tolerance
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Safety Assessment of Adverse Events
研究概览
简要总结
Evaluation of the safety and effects on glycemic control of medical food formulation WBF-0031 in subjects with abnormal glucose control.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Study product was provided for each arm in identical capsules.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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%
- •Clinically diagnosed gestational diabetes mellitus (GDM) during a previous pregnancy (may be self-reported)
- •Willing to comply with study requirements
- •Provide written informed consent
排除标准
- •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
结局指标
主要结局
Safety Assessment of Adverse Events
时间窗: 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
时间窗: 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.
次要结局
- Total Glucose Area Under the Curve (AUC) from baseline(24 weeks)
- Glucose peaks(30 weeks)
- A1c(Week 0, Week 12, Week 24)
- Incremental Glucose Area Under the Curve (AUC) from baseline(24 weeks)
研究者
Eden Miller
Principal Investigator
Diabetes and Obesity Care