NCT07210684招募中不适用
A Randomized, Double-Blind, Placebo-Controlled Trial on the Effects of Dihydroberberine (DHB) on Glucagon-Like Peptide-1 (GLP-1), Glycemic Control, and Subjective Rating of Appetite and Mood/Energy in Adults With Pre-Diabetes
Nanjing Nutrabuilding Bio-tech Co., Ltd.1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2025年8月6日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Change in Postprandial Total GLP-1 Cmax After Single Dose of DHB
研究概览
简要总结
The goal of this clinical trial is to learn if Dihydroberberine (DHB) supplementation affects adults with pre-diabetes.
The main questions it aims to answer are:
Does DHB supplementation increase the concentration of GLP-1 in the blood? Does DHB supplementation affect appetite, mood, and energy levels? Does DHB supplementation affect body weight, blood sugar control and insulin? Researchers will compare DHB supplementation to a placebo (a look-alike substance that contains no drug) to see if DHB has any effect.
Participants will:
Take DHB or a placebo every day for 6 weeks. Participate in tests to measure GLP-1 levels, blood glucose, insulin and other markers.
Have their continuous blood sugar profiles (with CGMs) monitored to see how much time their blood sugar spends in a healthy range.
Rate their appetite, mood, and energy levels using a visual analog scale.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1.35 - 65 years of age (inclusive). 2.BMI 25.0 - 35.0 kg/m2 (inclusive). 3.HbA1c 5.7% - 6.4% (39 - 47 mmol/mol, inclusive) measured at visit
- •4.Participant has a score of 7 - 10 on the Vein Access Scale Assessment at visit
- •5.Non-user or former user (daily use; cessation ≥12 months) of tobacco or nicotine products (e.g., cigarette smoking, vaping, chewing tobacco) within 12 months of visit 1, and has no plans to begin use during the study period.
- •6.Non-habitual users (i.e., daily or almost daily) of marijuana or hemp products, including CBD/THC products, and willing to abstain from use throughout the study period (topical creams/lotions are allowed).
- •7.Willing to wear a CGM sensor throughout study period and willing to adhere to instructions/ restrictions associated with the proper use and care of the CGM.
- •8.Willing to use personal smart phone with operating system capable of downloading and operating the Cronometer and Dexcom CGM apps for diet records and blood glucose, respectively.
- •9.Willing to adhere to all study procedures, including lifestyle considerations, and sign forms providing informed consent to participate in the study and authorization to release relevant protected health information to the Clinical Investigator.
排除标准
- •Extreme Diets: Extreme dietary habits (e.g., ketogenic, vegan/vegetarian) at investigator's discretion.
- •Intense Exercise: Moderate-to-intense physical training (≥5 hours/week).
- •Weight Instability/Program: Recent weight changes (>4.5 kg≤90 d) or current/planned weight change program.
- •Abnormal Labs: Abnormal lab test results of clinical significance at Visit 1 (one re-test allowed).
- •Uncontrolled Chronic Illness: Uncontrolled or clinically important pulmonary, cardiac, hepatic, renal, endocrine (T1D/T2D excluded), hematologic, immunologic, neurologic, psychiatric, or biliary disorders.
- •Clinically Important GI: Clinically important GI condition interfering with study product (e.g., IBD, celiac, weight loss surgery history).
- •Uncontrolled HTN: Uncontrolled hypertension (SBP≥160 mmHg and/or DBP≥100 mmHg).
- •Cancer History: History or presence of cancer in the prior 2 years (except non-melanoma skin cancer).
- •Active Infection: Signs/symptoms of active infection ≤5 d of Visit
- •Anti-Hyperglycemics: Recent use (≤6 mo) of any prescription anti-hyperglycemic medication.
- •Other Supplements: Use of dietary supplements (other than approved multivitamin) ≤14 d of Visit
- •Alcohol/Substance Abuse: History (≤12 months) of alcohol (>14 drinks/week) or substance abuse.
- •Antibiotics: Antibiotic use ≤90 d of Visit
- •Regular NSAIDs: Regular use (≥3 days/week≤30 d) of anti-inflammatory medications.
- •Steroid Use: Recent use (≤30 d) of oral/injectable steroids, or high-dose topical/inhaled steroids.
- •Unregistered Drug: Exposure to any non-registered drug product ≤30 d prior to Visit 1
- •Medication Instability: Unstable dose (≤90 d) of any other prescription medications (PRN excluded).
- •Psychiatric Hospitalization: Major affective/psychiatric disorder requiring hospitalization ≤12 months prior to Visit
- •Recent Trauma/Surgery: Major trauma or any surgical event ≤30 d of Visit
- •Recent GI Prep: Endoscopy or colonoscopy preparation ≤90 d prior to Visit
- •Planned Surgery: Scheduled or planning elective surgical procedures during the study.
- •Female Status: Pregnancy, lactation, planning pregnancy, or unwillingness to use approved contraception.
- •Allergies: Known sensitivity or allergy to any study products or foods.
- •Investigator Discretion: Any condition that interferes with compliance, confounds results, or presents undue risk.
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo 400 mg (Dietary Supplement)
Dihydroberberine（DHB）
Experimental
干预措施: Dihydroberberine（DHB）400 mg (Dietary Supplement)
结局指标
主要结局
Change in Postprandial Total GLP-1 Cmax After Single Dose of DHB
时间窗: Visit 3, Day 0 (after single dose administration)
Change in postprandial total glucagon-like peptide-1 (GLP-1) maximum concentration (Cmax) following a single dose of 200 mg DHB compared to placebo, measured at visit 3, day 0.
Change in GLP-1 Cmax From Baseline to End of Study After 6 Weeks of DHB
时间窗: Baseline to End of Study , approximately Week 6
Change in postprandial total GLP-1 maximum concentration (Cmax) from baseline to end of study after 6 weeks of daily supplementation with 400 mg DHB vs. placebo.
次要结局
- Change in Time to Maximum Concentration (Tmax) of Postprandial GLP-1 After Single Dose of DHB(0-120 minutes post-meal at Baseline and Acute Visit 3, Day 0)
- Change in Fasting Total GLP-1 Levels from Baseline (day -7) to the Acute Visit 3 (day 0)(From Baseline (Visit 2, Day -7) to Acute Visit (Visit 3, Day 0))
- Change in Postprandial GLP-1 AUC (piAUC0-120min) After Single Dose of DHB(0-120 minutes post-meal at Baseline and Acute Visit 3, Day 0)
- Change in Postprandial GLP-1 (piAUC0-120min) After 6 Weeks of Supplementation(Baseline (Visit 2, Day -7) to End of Study (Visit 4, Day 42), approximately Week 6)
- Postprandial Glucose and insulin Responses After Single Dose(0-120 minutes post-meal at Visit 3, Day 0)
- Mean Glucose and Variability of 24-Hour Continuous Glucose Monitoring (CGM) Glycemic Health Endpoints(24 hours following product intake (Visit 3, Day 0))
- Change in Subjective Appetite Perceptions After Single Dose of DHB(0-120 minutes post-meal at Visit 3, Day 0)
- Time In/Out of Range of 24-Hour Continuous Glucose Monitoring (CGM) Glycemic Health Endpoints(24 hours following product intake (Visit 3, Day 0))
- Change in Postprandial Total GLP-1 Time to Maximum Concentration (Tmax) from Baseline to Week 6(Baseline (Visit 2, Day -7) to End of Study (Visit 4, Day 42), approximately Week 6)
- Change in Fasting Plasma Total GLP-1 Levels from Baseline to Week 6(Baseline (Visit 2, Day -7) to End of Study (Visit 4, Day 42), approximately Week 6)
- Change in Postprandial Plasma Glucose Positive Incremental Area Under the Curve (piAUC0-120min) from Baseline After 6 Weeks of Supplementation(Baseline (Visit 2, day 0) to End of Study (Visit 4, Day 42), approximately Week 6)
- Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) After 6 Weeks(Baseline (Visit 2) to End of Study (Visit 4), approximately Week 6)
- Change in Postprandial Insulin Maximum Concentration (Cmax) from Baseline to Week 6(Baseline (Visit 2, day 0) to End of Study (Visit 4, Day 42), approximately Week 6)
- Change in Postprandial Plasma Glucose Maximum Concentration (Cmax) from Baseline After 6 Weeks of Supplementation(Baseline (Visit 2, day 0) to End of Study (Visit 4, Day 42), approximately Week 6)
- Change in Postprandial Plasma Glucose Time to Peak Concentration (Tmax) from Baseline After 6 Weeks of Supplementation(Baseline (Visit 2, day 0) to End of Study (Visit 4, Day 42), approximately Week 6)
- Change in Fasting Plasma Glucose Levels from Baseline to Week 6(Baseline (Visit 2, day 0) to End of Study (Visit 4, Day 42), approximately Week 6)
- Change in Postprandial Plasma Insulin Time to Peak Concentration (Tmax) from Baseline After 6 Weeks of Supplementation(Baseline (Visit 2, day 0) to End of Study (Visit 4, Day 42), approximately Week 6)
- Change in Postprandial Plasma Insulin Positive Incremental Area Under the Curve (piAUC0-120min) from Baseline After 6 Weeks of Supplementation(Baseline (Visit 2, day 0) to End of Study (Visit 4, Day 42), approximately Week 6)
- Change in Fasting Plasma Insulin Levels from Baseline to Week 6(Baseline (Visit 2, day 0) to End of Study (Visit 4, Day 42), approximately Week 6)
- Change in Appetite Perceptions for composite VAS ratings After 6 Weeks of Supplementation(Baseline (Visit 2, Day -7) to End of Study (Visit 4, Day 42), approximately Week 6)
- Change in Appetite Perceptions for individual VAS ratings After 6 Weeks of Supplementation(Baseline (Visit 2, day 0) to End of Study (Visit 4, Day 42), approximately Week 6)
- Time In/Out of Range of 7-Day Continuous Glucose Monitoring (CGM) Parameters After 6 Weeks(7-day monitoring period before Visit 2 (Day -7) and Visit 4 (Day 42))
- Mean Glucose Averaged and Variability of Over 7 Days from Baseline to Week 6(7-day monitoring period before Visit 2 (Day -7) and Visit 4 (Day 42))
研究者
研究点 (1)
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