Effects of a Dietary Supplement Containing Salacia Extract, Citrus Bioflavonoids, and Trivalent Chromium on Markers of Glucose Control and Quality of Life: A Randomized, Placebo-Controlled, Double-Blind Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Glucose kinetics
研究概览
简要总结
This study was a double-blind, randomized, placebo-controlled, clinical trial with two parallel groups. Participants reported to a single investigational center in Ohio (i.e., The Center for Applied Health Sciences) during the 12 week trial.
详细描述
This study was a double-blind, randomized, two-arm, placebo-controlled trial of apparently healthy men and women recruited at a single investigational center in Northeast Ohio (i.e. The Center for Applied Health Sciences).
Subjects will attend four study visits. During Visit 1, subjects will be screened for participation (i.e., medical history, physical exam, routine blood work [also HgA1c, insulin], background baseline diet). Over the next 12 weeks, subjects will attend Visits 2-4, wherein assessments of serum glucose, insulin, HOMA-IR, 2-hour glucose tolerance test (GTT), NMR profile, HgA1c, C-reactive protein, adiponectin, ferritin, waist circumference, quality of life questionnaire, and various visual analog scales for appetite, satiety, and cravings will be made (see Study Schematic for details).
Comprehensive side effect profile/ adverse event monitoring will take place throughout the study duration. The study will be conducted following ICH-GCP guidelines to ensure subject safety and scientific integrity of the data.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Investigator)
盲法说明
Supplements were blinded by the sponsor prior to initiation of any research activities. All research activities, including statistical analysis, were completed by the research team while blinded.
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Provide voluntary signed and dated informed consent.
- •Be in good health as determined by medical history and routine blood chemistries.
- •Age between the ages of 21 and 65 (inclusive).
- •Body Mass Index of 18.5-34.99 (inclusive).
- •Body weight of at least 120 pounds.
- •Fasting blood sugar of 100-125 (inclusive) OR HgA1c of 5.7-6.4% (inclusive).
- •Normotensive (seated, resting systolic blood pressure <140 mm Hg and diastolic blood pressure < 90 mm Hg. If the first measurement is slightly elevated above these limits, the subject will be given a brief (5 minute) rest period, and two more measurements will be taken. The average of all three measurements will be used to determine eligibility.
- •Normal seated, resting heart rate (<90 per minute).
- •Willing to duplicate their previous 24-hour diet, refrain from caffeine for 12 hrs and exercise
排除标准
- •History of unstable or new-onset cardiovascular or cardiorespiratory disease.
- •History of diabetes, or other endocrine disorder.
- •Fasting blood sugar of > 125 mg/dL or HgA1c of > 6.4%.
- •History of use of medications or dietary supplements known to affect glycemia or insulinemia.
- •History of hyperparathyroidism or an untreated thyroid disease.
- •History of malignancy in the previous 5 years except for non-melanoma skin cancer (basal cell cancer or squamous cell cancer of the skin).
- •Prior gastrointestinal bypass surgery (Lapband), etc.
- •Other known gastrointestinal or metabolic diseases that might impact nutrient absorption or metabolism, e.g. short bowel syndrome, diarrheal illnesses, history of colon resection, gastro paresis, Inborn-Errors-of-Metabolism (such as PKU).
- •Chronic inflammatory condition or disease (e.g. rheumatoid arthritis, Crohn's disease, ulcerative colitis, Lupus, HIV/AIDS, etc.).
- •Known sensitivity to any ingredient in the test formulations as listed in the Certificates-of-Analysis.
- •Currently participating in another research study with an investigational product or have been in another research study in the past 30 days.
- •Any other diseases or conditions that, in the opinion of the medical staff, could confound the primary endpoints or place the subject at increased risk of harm if they were to participate.
研究组 & 干预措施
Active
Tablet containing 400 mcg chromium (delivered as Crominex® 3+, a blend of chromium, Capros® Amla Extract (Fruit), PrimaVie® Shilajit), and 325 mg of MetaviveTM complex (Salacia Chinensis Extract (Fruit) and a Citrus Bioflavonoid Complex)
干预措施: Active (Dietary Supplement)
Placebo
Identical size, shape, and weight maltodextrin tablet
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Glucose kinetics
时间窗: Change from baseline to 12 weeks.
Serum glucose response during a two hour oral sucrose tolerance test.
Insulin kinetics
时间窗: Change from baseline to 12 weeks.
Serum insulin response during a two hour oral sucrose tolerance test.
次要结局
- Hemoglobin A1c (HgA1c)(Change from baseline to 12 weeks.)
- Ferritin(Change from baseline to 12 weeks.)
- C-reactive protein(Change from baseline to 12 weeks.)
- Adiponectin(Change from baseline to 12 weeks.)
- Appetite(Change from baseline to 12 weeks.)
- Blood urea nitrogen to creatinine ratio(Change from baseline to 12 weeks.)
- Satiety(Change from baseline to 12 weeks.)
- Sweet food cravings(Change from baseline to 12 weeks.)
- Food cravings(Change from baseline to 12 weeks.)