A Study to Evaluate the Effects of a Turmeric and Black Cumin Seed Formulation on Cholesterol Levels

September 4, 2018 updated by: Supplement Formulators, Inc.

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

The purpose of this study is to assess the effects of a turmeric and black cumin seed formulation on cholesterol levels.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

33

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Fort Lauderdale, Florida, United States, 33308
        • Life Extension Clinical Research, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Ambulatory, male or female, between 40 and 75 years of age

  2. Meeting one of the following two criteria:

    1. Having a BMI between 25.0 and 34.9
    2. Waist circumference > 40.0 inches in males and > 35.0 inches in females
  3. Having Total Cholesterol levels at Baseline/screening of between 190 and 239 mg/dl
  4. Generally healthy and having no difficulty with digestion or absorption of food
  5. Willing and able to give written informed consent
  6. Clearly understands the procedures and requirements for the study
  7. Able to maintain stable physical activity and dietary habits throughout the study
  8. Willing and able to comply with all study procedures and data recording obligations
  9. Having the capability of communicating, including reading in English

Exclusion Criteria:

  1. Having smoked any cigarette, electronic cigarette, cigar, pipe, or recreational drug in the past 30 days
  2. History of allergy or sensitivity to any component of the study products
  3. Donation of blood within 30 days prior Baseline/screening
  4. Participation in another study within 30 days prior to Baseline/screening
  5. Being pregnant, planning on becoming pregnant during study participation or breast feeding
  6. Having the following medical condition(s): diabetes, hypotension, hypertension (changed antihypertensive medication or dose in the preceding 3 months and/or likely to do so during the study), cardiovascular disease (arrhythmia, edema with or without congestive heart failure, heart attack, stroke, abnormal EKG), gastrointestinal disease requiring daily prescribed medication (gastroesophageal reflux, gastritis, and peptic or duodenal ulcer), gallbladder disease or gallstones, biliary obstruction (past or present), endocrine disease (hyper- or hypothyroidism), psychiatric disorder (anxiety if untreated, eating disorder) neurologic disease (Parkinson's disease, intracranial hemorrhage, head injury, brain tumor, evidence of delirium, confusion, dementia, Alzheimer's disease, migraine headache (if last migraine headache was < 3 years prior to Baseline/screening), urologic disease, chronic inflammatory or autoimmune disease, cancer (unless skin cancer other than melanoma which has been treated > 3 years prior to Baseline/screening), liver and kidney disease, insomnia, blood coagulation disorder (anemia, thrombus, embolism), sleep apnea, or other condition(s) that would preclude participation in the study in the judgment of the investigator/sub-investigator (Sub-I).
  7. Currently taking or having taken cholesterol-lowering medication(s) including HMGCR inhibitors, cholesterol binding resins, fibrates, or nicotinic acid >1 gram/day within 30 days prior to screening
  8. Currently taking or having taken a supplemental product that may affect cholesterol levels (red yeast rice, red mold dioscorea, guggulipid, policosanol, pantethine, beta-sitosterol, artichoke leaf, or supplemental fiber) within 30 days prior to Baseline/screening
  9. Currently taking or having taken a fish oil or krill oil product within 30 days prior to Baseline/screening
  10. Currently taking or having taken anxiolytics and sedative hypnotics, anticonvulsants, antineoplastics, anti-migraine medication(s), opioid analgesics, monoamine oxidase inhibitors (MAOIs), phosphodiesterase inhibitors, adenosine reuptake inhibitors, dopamine agonists, dopamine antagonists, or immunosuppressants within 30 days prior to Baseline/screening
  11. Currently talking or having taken anti-inflammatory medication(s) within 14 days prior to screening (unless on a stable daily dose of aspirin 81mg for 3 months prior to screening and not likely to change dose during the study) or in the judgment of the PI/Sub-I would not preclude participation in the study
  12. Having had a surgical procedure, pacemaker or any internal medical device other than artificial joints which, in the judgment of the PI/Sub-I, would preclude participation in the study
  13. Having had a routine dental cleaning or other dental procedure within 14 days prior to Baseline/screening
  14. Having screening laboratory test values: bilirubin > 2.5 x ULN, AST/SGOT and ALT/SGPT > 2.5 x ULN, serum creatinine > 1.5 mg/dL, blood glucose > 125 mg/dL, or any other lab test result(s) that would preclude participation in the study in the judgment of the PI/Sub-I
  15. Having blood pressure readings at Baseline/screening > 140 systolic or > 90 diastolic on two consecutive readings unless permitted to proceed to the next visit in the judgment of the PI/Sub-I
  16. Currently consumes more than 6 standard alcoholic drinks per week (a standard alcoholic drink is defined as one bottle/can of beer, one glass of wine, or one ounce of hard liquor)
  17. History of known alcohol or substance abuse (e.g., opiates, benzodiazepines, or amphetamines)
  18. Unable or unwilling to avoid consuming grapefruit juice or fresh grapefruit, Seville oranges and tangelos
  19. Having any other significant circumstance that would preclude study participation in the judgment of the PI/Sub-I

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Dietary supplement: Placebo
Placebo
Experimental: Cholesterol Health Formulation
Turmeric and black cumin seed preparation
Dietary supplement: Turmeric and Black Cumin Seed
Turmeric and Black Cumin Seed formulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Cholesterol
Time Frame: 60 days
Mean change from Baseline/screening to Day 60
60 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
LDL Cholesterol
Time Frame: 60 days
Mean change from Baseline/screening to Day 60
60 days
Oxidized LDL
Time Frame: 60 days
Mean change from Baseline/screening to Day 60
60 days
Triglycerides
Time Frame: 60 days
Mean change from Baseline/screening to Day 60
60 days
HDL Cholesterol
Time Frame: 60 days
Mean change from Baseline/screening to Day 60
60 days
C-reactive protein (hs-CRP)
Time Frame: 60 days
Mean change from Baseline/screening to Day 60
60 days
Blood glucose
Time Frame: 60 days
Mean change from Baseline/screening to Day 60
60 days
Insulin
Time Frame: 60 days
Mean change from Baseline/screening to Day 60
60 days
Hemoglobin A1C
Time Frame: 60 days
Mean change from Baseline/screening to Day 60
60 days
Body weight
Time Frame: 60 days
Mean change from Day 1 (Enrollment) to Day 60
60 days
Blood pressure
Time Frame: 60 days
Mean change from Day 1 (Enrollment) to Day 60
60 days
SF-36 health survey scores
Time Frame: 60 days
Mean change from Day 1 (Enrollment) to Day 60
60 days
Waist circumference
Time Frame: 60 days
Mean change from Day 1 (Enrollment) to Day 60
60 days
Hip circumference
Time Frame: 60 days
Mean change from Day 1 (Enrollment) to Day 60
60 days
Waist-to-Hip ratio
Time Frame: 60 days
Mean change from Day 1 (Enrollment) to Day 60
60 days
LDL-P (NMR Lipoprofile)
Time Frame: 60 days
Mean change from Baseline/screening to Day 60
60 days
LDL-C (NMR Lipoprofile)
Time Frame: 60 days
Mean change from Baseline/screening to Day 60
60 days
HDL-C (NMR Lipoprofile)
Time Frame: 60 days
Mean change from Baseline/screening to Day 60
60 days
Triglycerides (NMR Lipoprofile)
Time Frame: 60 days
Mean change from Baseline/screening to Day 60
60 days
Cholesterol, Total (NMR Lipoprofile)
Time Frame: 60 days
Mean change from Baseline/screening to Day 60
60 days
HDL-P (Total) (NMR Lipoprofile)
Time Frame: 60 days
Mean change from Baseline/screening to Day 60
60 days
Small LDL-P (NMR Lipoprofile)
Time Frame: 60 days
Mean change from Baseline/screening to Day 60
60 days
LDL Size (NMR Lipoprofile)
Time Frame: 60 days
Mean change from Baseline/screening to Day 60
60 days
LP-IR Score (NMR Lipoprofile)
Time Frame: 60 days
Mean change from Baseline/screening to Day 60
60 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Supplement Formulators, Inc.

Investigators

  • Principal Investigator: Steven Joyal, M.D., Life Extension

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 12, 2017

Primary Completion (Actual)

August 10, 2018

Study Completion (Actual)

August 16, 2018

Study Registration Dates

First Submitted

May 31, 2017

First Submitted That Met QC Criteria

June 1, 2017

First Posted (Actual)

June 5, 2017

Study Record Updates

Last Update Posted (Actual)

September 5, 2018

Last Update Submitted That Met QC Criteria

September 4, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • CL086

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cholesterol Health

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Czech Republic

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe