Clinical trial NCT01981343: A Parallel Study Evaluating the Effect of A-F Betafood® on Gallbladder and Liver Function.
Official title: A Randomized, Double Blind, Placebo Controlled Parallel Study Evaluating the Effect of A-F Betafood® on Gallbladder and Liver Function.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Gallbladder
Keywords: Gallbladder motility
A-F Betafood
Betaine
Ejection fraction
Ejection rate
Ultrasound
Lead sponsor: KGK Science Inc.
Sponsor class: INDUSTRY
Collaborators: name: Standard Process Inc.
First posted: 2013-11-11
Enrollment: 50
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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


Eligibility criteria: 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

Primary outcomes:
measure: Gallbladder and Liver function
timeFrame: 12 weeks
Secondary outcomes:
measure: Gastrointestinal distress
timeFrame: 12 weeks
measure: Fasting Lipid Profile
timeFrame: 12 weeks
measure: Fasting Oxidized LDL
timeFrame: 12 weeks
measure: Fasting TNF-alpha
timeFrame: 12 weeks
measure: Fasting Adiponectin
timeFrame: 12 weeks
measure: Blood Pressure
timeFrame: Over 12 weeks
measure: Heart Rate
timeFrame: Over 12 weeks
measure: Biometrics: weight and BMI
timeFrame: Over 12 weeks
measure: Blood Safety Parameters
timeFrame: Over 12 weeks
measure: Fasting Malonyldialdehyde
timeFrame: 12 weeks
measure: Adverse events
timeFrame: Over 12 weeks
Other outcomes:
Locations:
city: London
country: Canada
facility: KGK Synergize Inc.
state: Ontario
Study officials:
affiliation: KGK Science Inc.
name: Tetyana Pelipyagina, MD
role: PRINCIPAL_INVESTIGATOR
References: