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Trial record 5 of 76 for:    Supplement | Turmeric

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

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ClinicalTrials.gov Identifier: NCT03175757
Recruitment Status : Completed
First Posted : June 5, 2017
Last Update Posted : September 5, 2018
Sponsor:
Information provided by (Responsible Party):
Supplement Formulators, Inc.

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

Condition or disease Intervention/treatment Phase
Cholesterol Health Dietary Supplement: Turmeric and Black Cumin Seed Dietary Supplement: Placebo Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Health Services Research
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
Actual Study Start Date : May 12, 2017
Actual Primary Completion Date : August 10, 2018
Actual Study Completion Date : August 16, 2018


Arm Intervention/treatment
Experimental: Cholesterol Health Formulation
Turmeric and black cumin seed preparation
Dietary Supplement: Turmeric and Black Cumin Seed
Turmeric and Black Cumin Seed formulation

Placebo Comparator: Placebo
Placebo
Dietary Supplement: Placebo
Placebo




Primary Outcome Measures :
  1. Total Cholesterol [ Time Frame: 60 days ]
    Mean change from Baseline/screening to Day 60


Secondary Outcome Measures :
  1. LDL Cholesterol [ Time Frame: 60 days ]
    Mean change from Baseline/screening to Day 60

  2. Oxidized LDL [ Time Frame: 60 days ]
    Mean change from Baseline/screening to Day 60

  3. Triglycerides [ Time Frame: 60 days ]
    Mean change from Baseline/screening to Day 60

  4. HDL Cholesterol [ Time Frame: 60 days ]
    Mean change from Baseline/screening to Day 60

  5. C-reactive protein (hs-CRP) [ Time Frame: 60 days ]
    Mean change from Baseline/screening to Day 60

  6. Blood glucose [ Time Frame: 60 days ]
    Mean change from Baseline/screening to Day 60

  7. Insulin [ Time Frame: 60 days ]
    Mean change from Baseline/screening to Day 60

  8. Hemoglobin A1C [ Time Frame: 60 days ]
    Mean change from Baseline/screening to Day 60

  9. Body weight [ Time Frame: 60 days ]
    Mean change from Day 1 (Enrollment) to Day 60

  10. Blood pressure [ Time Frame: 60 days ]
    Mean change from Day 1 (Enrollment) to Day 60

  11. SF-36 health survey scores [ Time Frame: 60 days ]
    Mean change from Day 1 (Enrollment) to Day 60

  12. Waist circumference [ Time Frame: 60 days ]
    Mean change from Day 1 (Enrollment) to Day 60

  13. Hip circumference [ Time Frame: 60 days ]
    Mean change from Day 1 (Enrollment) to Day 60

  14. Waist-to-Hip ratio [ Time Frame: 60 days ]
    Mean change from Day 1 (Enrollment) to Day 60

  15. LDL-P (NMR Lipoprofile) [ Time Frame: 60 days ]
    Mean change from Baseline/screening to Day 60

  16. LDL-C (NMR Lipoprofile) [ Time Frame: 60 days ]
    Mean change from Baseline/screening to Day 60

  17. HDL-C (NMR Lipoprofile) [ Time Frame: 60 days ]
    Mean change from Baseline/screening to Day 60

  18. Triglycerides (NMR Lipoprofile) [ Time Frame: 60 days ]
    Mean change from Baseline/screening to Day 60

  19. Cholesterol, Total (NMR Lipoprofile) [ Time Frame: 60 days ]
    Mean change from Baseline/screening to Day 60

  20. HDL-P (Total) (NMR Lipoprofile) [ Time Frame: 60 days ]
    Mean change from Baseline/screening to Day 60

  21. Small LDL-P (NMR Lipoprofile) [ Time Frame: 60 days ]
    Mean change from Baseline/screening to Day 60

  22. LDL Size (NMR Lipoprofile) [ Time Frame: 60 days ]
    Mean change from Baseline/screening to Day 60

  23. LP-IR Score (NMR Lipoprofile) [ Time Frame: 60 days ]
    Mean change from Baseline/screening to Day 60



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03175757


Locations
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United States, Florida
Life Extension Clinical Research, Inc.
Fort Lauderdale, Florida, United States, 33308
Sponsors and Collaborators
Supplement Formulators, Inc.
Investigators
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Principal Investigator: Steven Joyal, M.D. Life Extension

Publications:

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Responsible Party: Supplement Formulators, Inc.
ClinicalTrials.gov Identifier: NCT03175757     History of Changes
Other Study ID Numbers: CL086
First Posted: June 5, 2017    Key Record Dates
Last Update Posted: September 5, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Turmeric extract
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs