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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01981343
Other study ID # 12AGHS
Secondary ID
Status Completed
Phase Phase 2
First received November 5, 2013
Last updated April 10, 2018
Start date November 11, 2013
Est. completion date March 2018

Study information

Verified date April 2018
Source KGK Synergize Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
A-F Betafood

Other:
Placebo


Locations

Country Name City State
Canada KGK Synergize Inc. London Ontario

Sponsors (2)

Lead Sponsor Collaborator
KGK Synergize Inc. Standard Process Inc.

Country where clinical trial is conducted

Canada, 

Outcome

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