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

The Center for Applied Health Sciences, LLC1 site in 1 country86 target enrollmentDecember 15, 2021

ConditionsWaist Circumference Triglycerides Appetite Inflammation Lipids

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Waist Circumference
Sponsor: The Center for Applied Health Sciences, LLC
Enrollment: 86
Locations: 1
Primary Endpoint: waist circumference
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

December 15, 2021

End Date

December 15, 2022

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

The Center for Applied Health Sciences, LLC

Responsible Party

Sponsor

Eligibility Criteria

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.