Oral Supplementation With a Black Pepper Extract

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

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.

Study Overview

• Status: Completed
• Conditions: Inflammation; Triglycerides; Appetite; Lipids; Waist Circumference
• Intervention / Treatment: Dietary supplement: Black pepper extract

• Study Type: Interventional
• Enrollment (Actual): 86
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Canfield, Ohio, United States, 44406
      • The Center for Applied Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Placebo is maltodextrin, delivered as 2 capsules.	Dietary supplement: Black pepper extract; Subjects will be randomized to receive either the placebo or active (black pepper extract) in a 1:1
Active Comparator: Active; The active comparator is black pepper extract, delivered as 2 capsules.	Dietary supplement: Black pepper extract; Subjects will be randomized to receive either the placebo or active (black pepper extract) in a 1:1

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Appetite	appetite 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 satiety.	Change from baseline to week 12
Cravings	cravings as measured with a 10 cm anchored visual analogue scale, where higher values represent greater cravings.	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.	Chnage from baseline to week 12

Collaborators and Investigators

• Sponsor: The Center for Applied Health Sciences, LLC
• Collaborators: Brightseed, Inc

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2021
• Primary Completion (Actual): December 15, 2022
• Study Completion (Actual): December 15, 2022

Study Registration Dates

• First Submitted: December 17, 2021
• First Submitted That Met QC Criteria: January 5, 2022
• First Posted (Actual): January 20, 2022

Study Record Updates

• Last Update Posted (Actual): September 13, 2023
• Last Update Submitted That Met QC Criteria: September 11, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation
• Other Study ID Numbers: #21-CAHS-103

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No