Body Fat Reducing Effect and Safety of Enzymatically Modified Isoquercitrin in Overweight and Obese Subjects

This is an interventional basic science trial for Overweight Read More

Inclusion Criteria:

• Male or female age 18-65 years.
• Premenopausal female with regular menstrual cycle or post-menopausal female with cessation of menstrual cycle for a minimum of 6 months.
• BMI in the range of 28.0-35.0
• Beck Depression Inventory Score less than 20.
• Fluency in spoken or written English.
• Willingness to be randomized to take EMIQ or placebo.
• Must weigh at least 164lbs

Exclusion Criteria:

• Any major illness or condition that may interfere with study outcomes at the discretion of the study physician.
• Diabetes Type I & Type II, or use of any pharmacological treatment for diabetes.
• Use of medications that interfere with energy metabolism
• Receiving hormone therapy growth hormone, testosterone, or estrogen with the exception of hormone contraceptives.
• GI diseases, conditions or medications known to influence GI absorption including active peptic ulcer disease or inflammatory bowel disease such as ulcerative colitis, Crohn's disease, celiac disease, chronic diarrhea or constipation.
• Undergone gastric bypass or other bariatric weight loss procedure.
• Lipid lowering medications such as: bile acid sequestrants (Cholestyramine, Colestipol, Colesevelam, etc.), cholesterol absorption inhibitors (Ezetimibe-Zetia), and fibrates (Gemfibrozil, Clofibrate, Fenofibrate, Triclor). Exceptions to this exclusion are 3-hydroxy-3-methyl-glutaryl-coenzyme A reductase (HMG-CoA reductase or Statins).
• On or planning to participate in a weight loss program.
• Weight loss or weight gain greater than 10 lbs in the past 6 months.
• History of eating disorders, anorexia, bulimia, or binge-eating in the past 5 years.
• Participation in any regular endurance exercise: running, biking or aerobics (except walking) greater than 2.5 hours per week, or resistance training greater than once per week.
• Regular use of acid lowering medications (greater than 3 times per week) such as antacids, proton pump inhibitors (PPIs), or H2 blockers.
• Unstable thyroid disease.
• Psychiatric disorders including schizophrenia, bipolar, major depression or psychosis.
• Antidepressant medication: selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), monoamine oxidase (MAO) inhibitors, or tricyclic antidepressants (TCAs).
• Cancer of any type (except for non-melanoma skin) in the past 5 years.
• Use of chemotherapeutic agents.
• Pregnancy, planning to become pregnant during the study period, or breastfeeding.
• Unwilling to use effective birth control during study.
• History of bilateral mastectomy with nodal dissection.
• Alcohol use, on average, greater than 3 servings per day, 20 servings per week (Serving size: 12oz beer, 4oz wine, 2oz hard liquor), or self-reported binge drinking.
• Uncontrolled hypertension (HTN) determined at the discretion of the study MD or registered nurse (RN). HTN medications allowed in the study: angiotensin converting enzyme (ACE) inhibitors, calcium channel blockers, and diuretics.
• Medications for chronic obstructive pulmonary disease (COPD) or kidney disease.
• α-adrenergic or β-adrenergic blockers (oral or ocular) and diuretics.
• Renal or chronic kidney disease due to any condition, renovascular disease, or dialysis.
• Chronic liver disease such as hepatitis B, hepatitis C, or cirrhosis.
• Cardiovascular disease including: myocardial infarction, cerebrovascular disease (CVA), coronary artery bypass graft, stenosis greater than 50%, angina, coronary artery disease (CAD), congestive heart failure (CHF),peripheral vascular disease (PVD) or dysautonomia.
• History of autoimmune diseases such as rheumatoid arthritis, lupus, multiple sclerosis, vitiligo, or psoriasis.
• HIV or AIDS based on self-report.
• Steroid use with the exception of over-the-counter topical and nasal steroids such as Flonase.
• Allergy medication or regular antihistamine use.
• Seizure disorders. Acceptable if managed with medication and free of seizure activity for 5 years.
• Smoking or the use of nicotine replacement products in the past 6 months.
• Use of dietary supplements containing vitamins (except Calcium and Vitamin D), minerals, herbal or plant-based preparations, fish oil or homeopathic remedies during study participation unless willing to discontinue prior to enrollment.
• Current participation in another research study.
• Non-English speaking.
• No social security number.
• Participation in another research study.