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Waist CircumferenceNCT05199012

Oral Supplementation With a Black Pepper Extract

A study testing Black pepper extract in people with Waist Circumference and Triglycerides, run by The Center for Applied Health Sciences, LLC at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 21 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Waist Circumference, Triglycerides, Appetite
What is being tested?
Black pepper extract
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
86 participants
Where
1 siteUnited States
Study dates
15 Dec 2021to 15 Dec 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 16Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • The Center for Applied Health Sciences

    Canfield, Ohio, 44406

Other trials in United States

About this study

Official title: 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.

Being tested
Black pepper extract
Medical subject headings
Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Black pepper extractDietary supplement

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

Study groups in NCT05199012
Study groupRoleWhat they receive
PlaceboPlacebo comparatorPlacebo is maltodextrin, delivered as 2 capsules.
Receives: Dietary Supplement: Black pepper extract
ActiveActive comparatorThe active comparator is black pepper extract, delivered as 2 capsules.
Receives: Dietary Supplement: Black pepper extract

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. waist circumference

    measurement of waist circumference in centimeters

    Measured: Change from baseline to week 12

  2. triglycerides

    measurement of triglycerides in blood

    Measured: Change from baseline to week 12

Secondary outcomes (5)

  1. urinary ketones

    ketone concentration in urine

    Measured: Change from baseline to week 12

  2. plasma free fatty acids

    concentration of free fatty acids in plasma

    Measured: Change from baseline to week 12

  3. body weight

    body weight measurement in kg

    Measured: Change from baseline to week 12

  4. Body mass index

    body mass index (body weight relative to height)

    Measured: Change from baseline to week 12

  5. liver enzymes

    fasting levels of ALT and AST measured in international units per liter (IU/L)

    Measured: Change from baseline to week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jan 2022
  2. Study start15 Dec 2021
  3. Primary completion15 Dec 2022
  4. Study completion15 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
86 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05199012
Sponsor's protocol ID
#21-CAHS-103
Status last verified
Sep 2023
First submitted
17 Dec 2021
Last updated
13 Sep 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Black pepper extract in people with Waist Circumference and Triglycerides, run by The Center for Applied Health Sciences, LLC at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

waist circumference (time frame: Change from baseline to week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05199012.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2023.

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