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

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

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 Overview

• Status: Completed
• Conditions: Gallbladder
• Intervention / Treatment: Other: Placebo; Dietary supplement: A-F Betafood

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6A 5R8
      • KGK Synergize Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 36 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: KGK Science Inc.
• Collaborators: Standard Process Inc.

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2013
• Primary Completion (Actual): February 1, 2018
• Study Completion (Actual): March 1, 2018

Study Registration Dates

• First Submitted: November 5, 2013
• First Submitted That Met QC Criteria: November 5, 2013
• First Posted (Estimate): November 11, 2013

Study Record Updates

• Last Update Posted (Actual): April 11, 2018
• Last Update Submitted That Met QC Criteria: April 10, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: Ultrasound; Ejection fraction; Betaine; Gallbladder motility; A-F Betafood; Ejection rate
• Other Study ID Numbers: 12AGHS