Overview

This trial is active, not recruiting.

Condition gallbladder
Treatments a-f betafood, placebo
Phase phase 2
Sponsor KGK Synergize Inc.
Collaborator Standard Process Inc.
Start date November 2013
End date December 2015
Trial size 50 participants
Trial identifier NCT01981343, 12AGHS

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose prevention
Arm
(Experimental)
Two A-F Betafood tablets taken with a meal, 3 times daily for 12 weeks
a-f betafood
(Placebo Comparator)
2 Placebo tablets taken with a meal, 3 times daily for 12 weeks
placebo

Primary Outcomes

Measure
Gallbladder and Liver function
time frame: 12 weeks

Secondary Outcomes

Measure
Gastrointestinal distress
time frame: 12 weeks
Fasting Lipid Profile
time frame: 12 weeks
Fasting Oxidized LDL
time frame: 12 weeks
Fasting TNF-alpha
time frame: 12 weeks
Fasting Adiponectin
time frame: 12 weeks
Blood Pressure
time frame: Over 12 weeks
Heart Rate
time frame: Over 12 weeks
Biometrics: weight and BMI
time frame: Over 12 weeks
Blood Safety Parameters
time frame: Over 12 weeks
Fasting Malonyldialdehyde
time frame: 12 weeks
Adverse events
time frame: Over 12 weeks

Eligibility Criteria

Female participants from 40 years up to 75 years old.

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

Additional Information

Official title A Randomized, Double Blind, Placebo Controlled Parallel Study Evaluating the Effect of A-F Betafood® on Gallbladder and Liver Function.
Principal investigator Tetyana Pelipyagina, MD
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by KGK Synergize Inc..