Effects of a Dietary Supplement on Markers of Glucose Control and Quality of Life
- Conditions
- Blood Glucose
- Interventions
- Dietary Supplement: PlaceboDietary Supplement: Chromium
- Registration Number
- NCT05573607
- Lead Sponsor
- The Center for Applied Health Sciences, LLC
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 26
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.
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Consists of a maltodextrin tablet Active Chromium 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)
- Primary Outcome Measures
Name Time Method insulin change from baseline to week 12 measurement of insulin in blood
glucose change from baseline to week 12 measurement of glucose in blood
- Secondary Outcome Measures
Name Time Method satiety change from baseline to week 12 satiety as measured with a 10 cm anchored visual analogue scale, where higher values represent greater cravings.
adiponectin change from baseline to week 12 measurement of adiponectin in blood
alanine aminotransferase change from baseline to week 12 measurement of alanine aminotransferase in blood
creatinine change from baseline to week 12 measurement of creatinine in blood
aspartate aminotransferase change from baseline to week 12 measurement of aspartate aminotransferase in blood
cravings change from baseline to week 12 cravings as measured with a 10 cm anchored visual analogue scale, where higher values represent greater cravings.
blood urea nitrogen change from baseline to week 12 measurement of blood urea nitrogen in blood
Short Form Health Survey (SF-36) change from baseline to week 12 health status as measured with the SF-36 questionnaire, where scores range from 0 to 100, and higher values represent better health status.
Trial Locations
- Locations (1)
The Center for Applied Health Sciences
🇺🇸Canfield, Ohio, United States