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

Sponsor

KGK Science Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT01981343

Collaborator

Standard Process Inc. (Industry)

Enrollment

Location

Arms

51.6

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Gallbladder	Dietary Supplement: A-F Betafood Other: Placebo	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Nov 11, 2013

Actual Primary Completion Date :

Feb 1, 2018

Actual Study Completion Date :

Mar 1, 2018

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Gallbladder and Liver function [12 weeks]
Changes in Gallbladder Ultrasound and Liver function tests (fasting serum AST, ALT, GGT and hsCRP)

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 75 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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