Oral Supplementation With a Black Pepper Extract

Study Overview
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Brief Summary
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This study is a randomized, placebo-controlled, double-blind, two-arm trial of N=94 apparently healthy men and women to be recruited at a single investigational center in Northeast Ohio. Subjects will attend three study visits. During Visit 1, subjects will be screened for participation (i.e., medical history, physical exam, routine blood work, background baseline diet). Over the next 12 weeks, subjects will attend Visits 2 (baseline) and 3 (week 12), wherein assessments of body weight, waist circumference, urinary ketones, serum glucose, insulin, liver enzymes as well as other biomarkers of metabolic health, quality of life (SF-36 questionnaire), and various visual analog scales (VAS) for appetite, satiety, and cravings will be made.

Official Title
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Safety and Efficacy of Oral Supplementation With a Black Pepper Extract in Apparently Healthy Men and Women

Conditions
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Waist Circumference, Triglycerides, Appetite, Inflammation, Lipids

Intervention / Treatment
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* Dietary Supplement: Black pepper extract


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 25-34.99 (inclusive). Body weight of at least 120 pounds. 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 hr, abstain from exercise for 24 hr, and fast for 10 hours prior to each laboratory visit. Exclusion Criteria: History of unstable or new-onset cardiovascular or cardiorespiratory disease. Individuals diagnosed with diabetes or other endocrine disorder. Fasting blood sugar of > 126 mg/dL OR HgA1c of > 6.5%. History of use of medications or dietary supplements known to affect glycemia or insulinemia. Current use of amiodarone, anti-retroviral agents, corticosteroids, methotrexate, tamoxifen, valproate, amitriptyline (Elavil), codeine, desipramine (Norpramin), flecainide (Tambocor), haloperidol (Haldol), imipramine (Tofranil), metoprolol (Lopressor, Toprol XL), ondansetron (Zofran), paroxetine (Paxil), risperidone (Risperdal), tramadol (Ultram), venlafaxine (Effexor), cyclosporine, lithium, chlorzoxazone, theophylline, and bufuralol, cyclophosphamide, ifosfamide, barbiturates, bromobenzene, lovastatin (Mevacor), ketoconazole (Nizoral), itraconazole (Sporanox), fexofenadine (Allegra), triazolam (Halcion), glimepiride (Amaryl), glyburide (DiaBeta, Glynase PresTab, Micronase), insulin, pioglitazone (Actos), rosiglitazone (Avandia), etoposide, paclitaxel, vinblastine, vincristine, vindesine, amprenavir, indinavir, nelfinavir, saquinavir, cimetidine, ranitidine, diltiazem, verapamil, digoxin, erythromycin, cisapride (Propulsid),, loperamide (Imodium), quinidine, aspirin, clopidogrel (Plavix), dalteparin (Fragmin), enoxaparin (Lovenox), heparin, ticlopidine (Ticlid), warfarin (Coumadin), nevirapine, Pentobarbital (Nembutal), Phenytoin (Dilantin), Propranolol (Inderal), Rifampin, Amoxicillin (Amoxil, Trimox), Carbamazepine (Tegretol), Cefotaxime (Claforan), midazolam, diclofenac. History of hyperparathyroidism or an untreated thyroid disease. History of nephrotic syndrome or renal disease. History of alcohol abuse within the past year. 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 autoimmune disease (e.g., rheumatoid arthritis, hepatitis, Crohn's disease, ulcerative colitis, Lupus, HIV/AIDS, etc.). Female subjects who are pregnant, trying to become pregnant, or lactating. Women who participate in this study must agree to the use of contraception for the duration of the study and any woman that is sexually active will have to have a negative pregnancy test prior to enrolling. Women of childbearing age (any woman prior to menopause or surgically sterilized) regardless of their use of contraception will be provided a urine pregnancy test kit at their screening visit and take the test in private using the female lavatory after signing an informed consent. 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>Placebo is maltodextrin, delivered as 2 capsules. | Dietary Supplement: Black pepper extract<br>* Subjects will be randomized to receive either the placebo or active (black pepper extract) in a 1:1<br>|
| Active Comparator: Active<br>The active comparator is black pepper extract, delivered as 2 capsules. | Dietary Supplement: Black pepper extract<br>* Subjects will be randomized to receive either the placebo or active (black pepper extract) in a 1:1<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| waist circumference | measurement of waist circumference in centimeters | Change from baseline to week 12 | 
| triglycerides | measurement of triglycerides in blood | Change from baseline to week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| urinary ketones | ketone concentration in urine | Change from baseline to week 12 | 
| plasma free fatty acids | concentration of free fatty acids in plasma | Change from baseline to week 12 | 
| body weight | body weight measurement in kg | Change from baseline to week 12 | 
| Body mass index | body mass index (body weight relative to height) | Change from baseline to week 12 | 
| liver enzymes | fasting levels of ALT and AST measured in international units per liter (IU/L) | Change from baseline to week 12 |