The purpose of this study is to assess the effects of a turmeric and black cumin seed formulation on cholesterol levels.
This study is a randomized, single-blind, placebo-controlled study to evaluate the effects of a turmeric and black cumin seed formulation on cholesterol levels. Each subject will receive a specific dose of the formulation or placebo twice daily. Participants will undergo assessments of blood tests, vital signs, body weight, waist circumference, hip circumference and waist-to-hip ratio with completion of a questionnaire. The primary objective of the study is to assess the effects of the turmeric and black cumin seed formulation on fasting levels of Total Cholesterol. Secondary objectives include assessment of the effects of turmeric and black cumin seed formulation on: fasting levels of: LDL Cholesterol, parameters in the NMR LipoProfile®, Oxidized LDL, Triglycerides, HDL cholesterol, C-reactive protein, blood glucose, Insulin and Hemoglobin A1c, as well as the assessments of the values/scores of body weight, waist circumference, hip circumference, waist-to-hip ratio, blood pressure and the SF-36 survey scores.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Enrollment
33
Turmeric and Black Cumin Seed formulation
Placebo
Life Extension Clinical Research, Inc.
Fort Lauderdale, Florida, United States
Total Cholesterol
Mean change from Baseline/screening to Day 60
Time frame: 60 days
LDL Cholesterol
Mean change from Baseline/screening to Day 60
Time frame: 60 days
Oxidized LDL
Mean change from Baseline/screening to Day 60
Time frame: 60 days
Triglycerides
Mean change from Baseline/screening to Day 60
Time frame: 60 days
HDL Cholesterol
Mean change from Baseline/screening to Day 60
Time frame: 60 days
C-reactive protein (hs-CRP)
Mean change from Baseline/screening to Day 60
Time frame: 60 days
Blood glucose
Mean change from Baseline/screening to Day 60
Time frame: 60 days
Insulin
Mean change from Baseline/screening to Day 60
Time frame: 60 days
Hemoglobin A1C
Mean change from Baseline/screening to Day 60
Time frame: 60 days
Body weight
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Mean change from Day 1 (Enrollment) to Day 60
Time frame: 60 days
Blood pressure
Mean change from Day 1 (Enrollment) to Day 60
Time frame: 60 days
SF-36 health survey scores
Mean change from Day 1 (Enrollment) to Day 60
Time frame: 60 days
Waist circumference
Mean change from Day 1 (Enrollment) to Day 60
Time frame: 60 days
Hip circumference
Mean change from Day 1 (Enrollment) to Day 60
Time frame: 60 days
Waist-to-Hip ratio
Mean change from Day 1 (Enrollment) to Day 60
Time frame: 60 days
LDL-P (NMR Lipoprofile)
Mean change from Baseline/screening to Day 60
Time frame: 60 days
LDL-C (NMR Lipoprofile)
Mean change from Baseline/screening to Day 60
Time frame: 60 days
HDL-C (NMR Lipoprofile)
Mean change from Baseline/screening to Day 60
Time frame: 60 days
Triglycerides (NMR Lipoprofile)
Mean change from Baseline/screening to Day 60
Time frame: 60 days
Cholesterol, Total (NMR Lipoprofile)
Mean change from Baseline/screening to Day 60
Time frame: 60 days
HDL-P (Total) (NMR Lipoprofile)
Mean change from Baseline/screening to Day 60
Time frame: 60 days
Small LDL-P (NMR Lipoprofile)
Mean change from Baseline/screening to Day 60
Time frame: 60 days
LDL Size (NMR Lipoprofile)
Mean change from Baseline/screening to Day 60
Time frame: 60 days
LP-IR Score (NMR Lipoprofile)
Mean change from Baseline/screening to Day 60
Time frame: 60 days