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A randomized, double blind, placebo controlled parallel study evaluating the effect of A-F Betafood®

A randomized, double blind, placebo controlled parallel study evaluating the effect of A-F Betafood®

  • Center /Company - KGK Synergize
  • IRB-HSR number - 28346CDN/1
  • Primary Investigator (PI) - Dr. Dale Wilson
  • Purpose of Study - The purpose of this study is to assess the effect of A-F Betafood® on gallbladder and liver function as measured by gallbladder ultrasounds and liver function tests (AST, ALT, GGT and hsCRP).
  • Compensation Provided - Yes
  • Compensation Details - Compensation up to $225.00
  • Time Commitment - 12 weeks with 4 visits to our clinic
  • Procedures Required - Blood Tests, Ultrasound, 3-day food records
  • Ages Eligibility - 40-75 years of age
  • Gender Eligibility - Female
  • Healthy Volunteers - Both
  • Contact Person - Clinic Recruiter
  • Exclusion Criteria - • Women who are pregnant, breastfeeding, or planning to become pregnant during the course of the trial • Unstable psychiatric disorder requiring hospitalization within past 6 months • Use of prescription medications, over the counter medications or natural health products/dietary supplements known to affect gastric/gastrointestinal function within 4 weeks of randomization • Presence of gallstones as determined by ultrasound • Uncontrolled hypertension defined as untreated systolic blood pressure > 160 mmHg and/or diastolic blood pressure > 100 mmHg • Clinically significant abnormal laboratory results at screening including • AST, ALT and/or bilirubin > 2 x the ULN • Serum creatinine >1.5 x the ULN or eGFR < 60 • Hemoglobin < 123 g/L • Participation in a clinical research trial within 30 days prior to randomization • Allergy or sensitivity to test article ingredients, soy, dairy, egg, wheat, peanut, tree nuts, fish or shellfish. • Individuals who are cognitively impaired and/or who are unable to give informed consent • 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
  • Inclusion Criteria - • Females 40-75 years of age or older not of child bearing potential. Defined as females who have had a hysterectomy or oophrectomy, 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: • 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 • Double-barrier method (condoms with spermicide or diaphragm with spermicide) • Vasectomy of partner (shown successful as per appropriate follow-up) • Abstinence • BMI of 25.0 kg/m2 to 29.9 kg/m2 • Agrees to comply with study procedures • Healthy as determined by laboratory results, medical history and physical exam • Has given voluntary, written, informed consent to participate in the study • Gastrointestinal distress with various fatty foods as determined by the modified GSRS questionnaire OR • Family history of gallbladder disease or previous history of gallbladder attacks • Has a normal resting heart rate 50-80bpm



 

We are looking for volunteers to be involved in a clinical research study that will investigate the effect of a natural health product on gallbladder and liver function in women.

 

The study will last approximately 12 weeks.  There will be 4 visits to our clinic and 2 ultrasound appointments. There will also be 2 phone calls during the study.  Each visit will take approximately one hour and each phone call will take 5-10 minutes to complete. The ultrasound appointments will be set up for you at London X-Ray.

 

The study product will be provided to you as 2 tablets to be taken three times daily with meals for 12 weeks.  You will be asked to record the daily use of the study product in a diary.

 

You will be required to give blood samples three times during the study.  The study requires that you come to the clinic fasting, nothing to eat or drink except water for 12 hours, prior to these appointments. 

 

You will be asked to complete a three day food record 3 times during the study.  You will also be asked to complete a questionnaire about your gastrointestinal symptoms once a week for the duration of the study.




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Suite 1440, 255 Queens Ave. London, ON Canada Canada, Ontario N6A5R8 Canada




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