Oral Supplementation With a Black Pepper Extract
NCT05199012 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 86
Last updated 2023-09-13
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
- DIETARY_SUPPLEMENT
-
Black pepper extract
Subjects will be randomized to receive either the placebo or active (black pepper extract) in a 1:1
Sponsors & Collaborators
-
Brightseed, Inc
collaborator UNKNOWN -
The Center for Applied Health Sciences, LLC
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- BASIC_SCIENCE
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 21 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2021-12-15
- Primary Completion
- 2022-12-15
- Completion
- 2022-12-15
Countries
- United States
Study Locations
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