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A Randomized, Double-blind, Placebo Controlled, Parallel Study for the Assessment of Anti-hypertensi

A Randomized, Double-blind, Placebo Controlled, Parallel Study for the Assessment of Anti-hypertensi

  • Center /Company - KGK Synergize
  • IRB-HSR number - 2014-MAY-09
  • Primary Investigator (PI) - Dr. Dale Wilson
  • Purpose of Study - We are looking for volunteers to enroll in a clinical research study that will investigate the effect of a dietary supplement on changes in blood pressure in adults with mild or moderate hypertension. The Purpose of this study is to assess the change in daytime ambulatory systolic blood pressure (SBP) and the change in office SBP during the 8 week intervention in the active group in reference to control.
  • Compensation Provided - Yes
  • Compensation Details - Compensation up to $250.00
  • Time Commitment - 12 Week Study with 6 Visits to the clinic
  • Procedures Required - Blood tests, Ambulatory Blood Pressure Monitor, 3-Day Food Records, 24-hour Urine Collection
  • Ages Eligibility - 30-75
  • Gender Eligibility - Male and Female
  • Healthy Volunteers - Both
  • Contact Person - Clinic Recruiter
  • Exclusion Criteria - 1. Women who are pregnant, breastfeeding, or planning to become pregnant during the course of the trial 2. Body mass index ? 35 kg/m2 3. Antihypertensive drug treatment, regular high dose NSAID treatment, use of cyclosporine or tacrolimusin 4. Any history of cardiovascular disease (myocardial infarction, unstable angina pectoris, coronary artery bypass graft, percutaneous transluminal coronary angioplasty, temporal ischemic attack) including stroke and congestive heart failure 5. Dementia, hypertensive retinopathy, left ventricular dysfunction or peripheral artery disease 6. Anemia, abnormal electrolytes, proteinuria, abnormal liver, kidney and thyroid function (except subjects on thyroid replacement therapy) Clinically significant biochemistry defined as: • Serum Sodium: <134 mmol/L or >148 mmol/L • Fasting serum Glucose: >7.0 mmol/L • Serum TSH: <0.3 mU/I or >4.5 mU/I • Serum GGT: 2 upper limits of reference range • eGFR: <60 mL/min Any other clinically significant abnormality in hematology and/or biochemistry at the Investigator’s discretion 7. Secondary hypertension 8. Diabetes (type 1 and type 2 diabetes) 9. History of cancer or malignant disease within the past 5 years(excluding basal cell carcinoma) 10. Any metabolic disease, gastrointestinal disorder or other clinically significant disease/disorder which in the Investigator’s opinion could interfere with the results of the study or the safety of the subject 11. Dietary restriction (fish and other seafood allergies, citrus allergies, multiple food allergies) 12. Alcohol abuse and/or illicit drug consumption; subjects consuming more than 14 portions of alcohol per week (one portion = 1 oz. spirits or 4 oz. wine or 11oz. medium strength beer / cider) Smokers and tobacco/snuff/nicotine users 13. Consumption of natural health products targeted to blood pressure lowering within 30 days before randomization and during the study 14. Participation in a clinical research trial within 30 days prior to randomization or during the study 15. Individuals who are cognitively impaired and/or who are unable to give informed consent 16. Any other condition which in the Investigator's opinion may adversely affect the subject's ability to complete the study or its measures or which may pose significant risk to the subject 17. Individuals who do not agree to abstain from donating blood during the study and for 30 days after the last dose of study product.
  • Inclusion Criteria - 1. Male or female aged 30 to 75 years inclusive (independent and home-living subject). 2. If female, subject is not of child bearing potential. Defined as females who have had a hysterectomy or oophorectomy, bilateral tubal ligation or are post-menopausal (natural or surgically with > 1 year since last menstruation). OR Female subject of childbearing potential must agree to use a medically approved method of birth control and have a negative urine pregnancy test result. Acceptable methods of birth control include: • Double-barrier method (condoms with spermicide or diaphragm with spermicide) • Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System). • Intrauterine devices • Vasectomy of partner 3. Mild or moderate hypertension (SBP 140-160 mmHg and DBP ? 100mmHg) (mean of office blood pressure measurements at the two first study visits during run-in period (visits 1 (-4 week) and 2 (-2 week)) and at baseline. Average office SBP baseline to be as close to 150mm Hg (i.e. 147-149 mmHg) as possible. 4. Body weight ?60kg 5. Stable body weight (self-reported weight gain or loss <5kg in the past three months) 6. Has given voluntary, written, informed consent to participate in the study 7. Agrees to comply with study procedures including willingness to fast at least 12 hours before blood samples and abstain from alcohol two days prior to blood sampling and blood pressure measurement and abstain from coffee at least 14 hours before blood pressure measurement and abstain from physical exercise at least 4 hours before blood pressure measurement



 

We are looking for volunteers to enroll in a clinical research study that will investigate the effect of a dietary supplement on changes in blood pressure in adults with mild or moderate hypertension.

 

The study will last approximately 12 weeks.  There will be 6 visits to our clinic during the study.  Visit 3, Visit 5 and Visit 6 will be conducted over two days for the purposes of obtaining a 24 hour blood pressure measurement.  Each visit will take approximately one hour or less to complete.

 

The study product will be provided to you as, 2 tablets taken once a day for 56 days.  You will be asked to maintain a study diary to record the time you take the study product each day.

 

You will be required to wear an ambulatory blood pressure monitor for 24 hours 3 times during the study.

 

You must be willing to have blood drawn 3 times during the study and for those visits you will come to the clinic fasting, nothing to eat or drink except water for 12 hours prior to those visits.  You will also be asked to complete a 24 hour urine collection twice during the study.

 

Prior to all study visits, you will be asked to abstain from alcohol for at least 48 hours, abstain from coffee for at least 14 hours and abstain from physical exercise for 4 hours

 

You will be asked to complete a three day food record 3 times during the study.




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