NCT01981343

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.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: KGK Science Inc. · Industry
• Sex: Female
• Age: 40 Years – 75 Years
• Healthy volunteers: Accepted

Summary

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

Conditions

• Gallbladder

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	A-F Betafood
OTHER	Placebo

Timeline

• Start date: 2013-11-11
• Primary completion: 2018-02-01
• Completion: 2018-03-01
• First posted: 2013-11-11
• Last updated: 2018-04-11

Locations

1 site across 1 country: Canada