NCT05199012

Oral Supplementation With a Black Pepper Extract

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 86 (actual)
• Sponsor: The Center for Applied Health Sciences, LLC · Industry
• Sex: All
• Age: 21 Years – 65 Years
• Healthy volunteers: Accepted

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

Interventions

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

Timeline

• Start date: 2021-12-15
• Primary completion: 2022-12-15
• Completion: 2022-12-15
• First posted: 2022-01-20
• Last updated: 2023-09-13

Locations

1 site across 1 country: United States