Effects of a Dietary Supplement on Markers of Glucose Control and Quality of Life

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Blood Glucose

Intervention / Treatment
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* Dietary Supplement: Placebo
* Dietary Supplement: Chromium


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Consists of a maltodextrin tablet | Dietary Supplement: Placebo<br>* Maltodextrin tablet<br>|
| Active Comparator: Active<br>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) | Dietary Supplement: Chromium<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| glucose | measurement of glucose in blood | change from baseline to week 12 | 
| insulin | measurement of insulin in blood | change from baseline to week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cravings | cravings as measured with a 10 cm anchored visual analogue scale, where higher values represent greater cravings. | change from baseline to week 12 | 
| satiety | satiety as measured with a 10 cm anchored visual analogue scale, where higher values represent greater cravings. | change from baseline to week 12 | 
| adiponectin | measurement of adiponectin in blood | change from baseline to week 12 | 
| blood urea nitrogen | measurement of blood urea nitrogen in blood | change from baseline to week 12 | 
| creatinine | measurement of creatinine in blood | change from baseline to week 12 | 
| alanine aminotransferase | measurement of alanine aminotransferase in blood | change from baseline to week 12 | 
| aspartate aminotransferase | measurement of aspartate aminotransferase in blood | change from baseline to week 12 | 
| Short Form Health Survey (SF-36) | health status as measured with the SF-36 questionnaire, where scores range from 0 to 100, and higher values represent better health status. | change from baseline to week 12 |