A Parallel Study Evaluating the Effect of A-F Betafood® on Gallbladder and Liver Function.

Study Overview
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Brief Summary
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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

Official Title
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A Randomized, Double Blind, Placebo Controlled Parallel Study Evaluating the Effect of A-F Betafood® on Gallbladder and Liver Function.

Conditions
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Gallbladder

Intervention / Treatment
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* Dietary Supplement: A-F Betafood
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Females 40-75 years of age or older 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 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 Family history of gallbladder disease or previous history of gallbladder attacks Has a normal resting heart rate 50-80bpm 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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A-F Betafood<br>Two A-F Betafood tablets taken with a meal, 3 times daily for 12 weeks | Dietary Supplement: A-F Betafood<br> <br> |
| Placebo Comparator: Placebo<br>2 Placebo tablets taken with a meal, 3 times daily for 12 weeks | Other: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gallbladder and Liver function | Changes in Gallbladder Ultrasound and Liver function tests (fasting serum AST, ALT, GGT and hsCRP) | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastrointestinal distress | Modified GSRS questionnaire | 12 weeks | 
| Fasting Lipid Profile | Changes in serum LDL-C, HDL-C, total cholesterol and triglycerides | 12 weeks | 
| Fasting Oxidized LDL | Changes in serum oxidized LDL levels | 12 weeks | 
| Fasting TNF-alpha | Changes in serum TNF-alpha levels | 12 weeks | 
| Fasting Adiponectin | Changes in serum adiponectin levels | 12 weeks | 
| Blood Pressure | Changes in mean office blood pressure | Over 12 weeks | 
| Heart Rate | Changes in mean heart rate | Over 12 weeks | 
| Biometrics: weight and BMI | Changes in mean weight and BMI | Over 12 weeks | 
| Blood Safety Parameters | Changes in complete blood count, electrolytes (Na, K, Cl), creatinine, eGFR, AST, ALT,GGT, bilirubin | Over 12 weeks | 
| Fasting Malonyldialdehyde | Changes in serum malonyldialdehyde (MDA) levels | 12 weeks | 
| Adverse events | Record and monitor any adverse events | Over 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gallbladder motility, A-F Betafood, Betaine, Ejection fraction, Ejection rate, Ultrasound