Ignite Creation Date:
2025-12-24 @ 6:59 PM
Ignite Modification Date:
2026-01-04 @ 3:44 AM
Study NCT ID:
NCT03175757
Status:
COMPLETED
Last Update Posted:
2018-09-05
First Post:
2017-05-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Effects of a Turmeric and Black Cumin Seed Formulation on Cholesterol Levels
Sponsor:
Supplement Formulators, Inc.
Organization:
Study Overview
Official Title:
A Randomized, Single-blind, Placebo-controlled Study to Evaluate the Effects of a Turmeric and Black Cumin Seed Formulation on Cholesterol Levels Among Generally Healthy Participants
Status:
COMPLETED
Status Verified Date:
2018-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to assess the effects of a turmeric and black cumin seed formulation on cholesterol levels.
Detailed Description:
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: