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
- insulin
研究概览
简要总结
This study is a double-blind, randomized, two-arm, placebo-controlled trial of apparently healthy men and women to be 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), 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.
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)
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 bloodpressure < 90 mm Hg.
- •Normal seated, resting heart rate (<90 per minute). Willing to duplicate their previous 24-hour diet, refrain from caffeine for 12 hrs and exercise for 24 hr prior to each trial, and fast for 10 hours prior each of the treatments.
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
Placebo
Consists of a maltodextrin tablet
干预措施: Placebo (Dietary Supplement)
Active
A tablet consisting of a blend of Crominex® 3+, Capros® Amla Extract (Fruit), PrimaVie® Shilajit), and MetaviveTM complex (Salacia Chinensis Extract (Fruit) and a Citrus Bioflavonoids)
干预措施: Chromium (Dietary Supplement)
结局指标
主要结局
insulin
时间窗: change from baseline to week 12
measurement of insulin in blood
glucose
时间窗: change from baseline to week 12
measurement of glucose in blood
次要结局
- satiety(change from baseline to week 12)
- adiponectin(change from baseline to week 12)
- alanine aminotransferase(change from baseline to week 12)
- creatinine(change from baseline to week 12)
- aspartate aminotransferase(change from baseline to week 12)
- cravings(change from baseline to week 12)
- blood urea nitrogen(change from baseline to week 12)
- Short Form Health Survey (SF-36)(change from baseline to week 12)