Oral Supplementation With a Black Pepper Extract

NCT05199012 | Completed

• 1 other identifier: #21-CAHS-103
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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.

Conditions

Waist Circumference; Triglycerides; Appetite; Inflammation; Lipids

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• urinary ketones

  Change from baseline to week 12

• plasma free fatty acids

  Change from baseline to week 12

• body weight

  Change from baseline to week 12

• Body mass index

  Change from baseline to week 12

• liver enzymes

  Change from baseline to week 12

Other Outcomes (4)

• Appetite

  Change from baseline to week 12

• Satiety

  Change from baseline to week 12

• Cravings

  Change from baseline to week 12

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo is maltodextrin, delivered as 2 capsules.

Dietary Supplement: Black pepper extract

Active

ACTIVE COMPARATOR

The active comparator is black pepper extract, delivered as 2 capsules.

Dietary Supplement: Black pepper extract

Interventions

Black pepper extract DIETARY_SUPPLEMENT

Subjects will be randomized to receive either the placebo or active (black pepper extract) in a 1:1

Active; Placebo

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Center for Applied Health Sciences, LLC: lead
• Brightseed, Inc: collaborator

Study Sites (1)

The Center for Applied Health Sciences

Canfield, Ohio, 44406, United States

Location

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2021
• First Posted: January 20, 2022
• Study Start: December 15, 2021
• Primary Completion: December 15, 2022
• Study Completion: December 15, 2022
• Last Updated: September 13, 2023

Record last verified: 2023-09

Locations

US (1)