Gallstone formation is multifactorial: immutable risk factors include genetics and ethnicity, age and being female, and mutable risk factors include obesity, and metabolic syndrome, diet, rapid weight loss, and other conditions such as cirrhosis, Crohn's disease, irritable bowel syndrome, gallbladder stasis, and the use of certain drugs like Ceftriazone. Previous studies have linked serum cholesterol, and low-density lipoprotein cholesterol levels and fatty liver disease to gallbladder disease. Given betaine's reported beneficial effects on fatty liver and lipid profile, A-F Betafood® may have a beneficial effect on gallbladder function. The objective of the study is to assess the effect of A-F Betafood® on gallbladder and liver function as measured by gallbladder ultrasounds and liver function tests. The hypothesis is that A-F Betafood® will improve gallbladder and liver function after the 12 week treatment period. This is a single-center, randomized, double-blind, placebo-controlled, parallel group study with two arms. This study will consist of a single 12 week treatment period. The planned sample size for this study is 50 overweight female subjects, with 25 subjects randomized equally to each of the two study arms in double-blind manner at a ratio of 1:1
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
50
KGK Synergize Inc.
London, Ontario, Canada
Gallbladder and Liver function
Changes in Gallbladder Ultrasound and Liver function tests (fasting serum AST, ALT, GGT and hsCRP)
Time frame: 12 weeks
Gastrointestinal distress
Modified GSRS questionnaire
Time frame: 12 weeks
Fasting Lipid Profile
Changes in serum LDL-C, HDL-C, total cholesterol and triglycerides
Time frame: 12 weeks
Fasting Oxidized LDL
Changes in serum oxidized LDL levels
Time frame: 12 weeks
Fasting TNF-alpha
Changes in serum TNF-alpha levels
Time frame: 12 weeks
Fasting Adiponectin
Changes in serum adiponectin levels
Time frame: 12 weeks
Blood Pressure
Changes in mean office blood pressure
Time frame: Over 12 weeks
Heart Rate
Changes in mean heart rate
Time frame: Over 12 weeks
Biometrics: weight and BMI
Changes in mean weight and BMI
Time frame: Over 12 weeks
Blood Safety Parameters
Changes in complete blood count, electrolytes (Na, K, Cl), creatinine, eGFR, AST, ALT,GGT, bilirubin
Time frame: Over 12 weeks
Fasting Malonyldialdehyde
Changes in serum malonyldialdehyde (MDA) levels
Time frame: 12 weeks
Adverse events
Record and monitor any adverse events
Time frame: Over 12 weeks
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