An interventional study of Black pepper extract in Waist Circumference, Triglycerides and Appetite, sponsored by The Center for Applied Health Sciences, LLC. Completed at 1 site in United States. Open to participants aged 21 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-13.
Sponsored by The Center for Applied Health Sciences, LLC · Not applicable, Interventional, and Basic science
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.
3,439 studies on the registry are indexed under Inflammation; 629 are open to participants now.
This study's enrollment of 86 is above the median of 50 across 2,437 interventional studies indexed under Inflammation.
Browse Inflammation studies →The Center for Applied Health Sciences, LLC is the lead sponsor of 13 studies on the registry; none are open to participants now.
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Placebo is maltodextrin, delivered as 2 capsules.
Dietary Supplement: Black pepper extract
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
waist circumference
measurement of waist circumference in centimeters
Time frame: Change from baseline to week 12
triglycerides
measurement of triglycerides in blood
Time frame: Change from baseline to week 12
urinary ketones
ketone concentration in urine
Time frame: Change from baseline to week 12
plasma free fatty acids
concentration of free fatty acids in plasma
Time frame: Change from baseline to week 12
body weight
body weight measurement in kg
Time frame: Change from baseline to week 12
Body mass index
body mass index (body weight relative to height)
Time frame: Change from baseline to week 12
liver enzymes
fasting levels of ALT and AST measured in international units per liter (IU/L)
Time frame: Change from baseline to week 12
Appetite
appetite as measured with a 10 cm anchored visual analogue scale, where higher values represent greater cravings.
Time frame: Change from baseline to week 12
Satiety
satiety as measured with a 10 cm anchored visual analogue scale, where higher values represent greater satiety.
Time frame: Change from baseline to week 12
Cravings
cravings as measured with a 10 cm anchored visual analogue scale, where higher values represent greater cravings.
Time frame: 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.
Time frame: Chnage from baseline to week 12
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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