GallbladderPhase 2NCT01981343
A Parallel Study Evaluating the Effect of A-F Betafood® on Gallbladder and Liver Function.
A Phase 2 study testing A-F Betafood in people with Gallbladder, run by KGK Science Inc. at 1 site in Canada.
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… Read more about this study
- Who is it for?
- Ages 40 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gallbladder
- What is being tested?
- A-F Betafood
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- 11 Nov 2013to Mar 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double Blind, Placebo Controlled Parallel Study Evaluating the Effect of A-F Betafood® on Gallbladder and Liver Function.
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
- Being tested
- A-F Betafood, Placebo
- Keywords
- Gallbladder motility, A-F Betafood, Betaine, Ejection fraction, Ejection rate, Ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A-F BetafoodDietary supplement
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| A-F Betafood | Experimental | Two A-F Betafood tablets taken with a meal, 3 times daily for 12 weeks Receives: Dietary Supplement: A-F Betafood |
| Placebo | Placebo comparator | 2 Placebo tablets taken with a meal, 3 times daily for 12 weeks Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gallbladder and Liver function
Changes in Gallbladder Ultrasound and Liver function tests (fasting serum AST, ALT, GGT and hsCRP)
Measured: 12 weeks
Secondary outcomes (11)
Gastrointestinal distress
Modified GSRS questionnaire
Measured: 12 weeks
Fasting Lipid Profile
Changes in serum LDL-C, HDL-C, total cholesterol and triglycerides
Measured: 12 weeks
Fasting Oxidized LDL
Changes in serum oxidized LDL levels
Measured: 12 weeks
Fasting TNF-alpha
Changes in serum TNF-alpha levels
Measured: 12 weeks
Fasting Adiponectin
Changes in serum adiponectin levels
Measured: 12 weeks
Blood Pressure
Changes in mean office blood pressure
Measured: Over 12 weeks
Heart Rate
Changes in mean heart rate
Measured: Over 12 weeks
Biometrics: weight and BMI
Changes in mean weight and BMI
Measured: Over 12 weeks
Blood Safety Parameters
Changes in complete blood count, electrolytes (Na, K, Cl), creatinine, eGFR, AST, ALT,GGT, bilirubin
Measured: Over 12 weeks
Fasting Malonyldialdehyde
Changes in serum malonyldialdehyde (MDA) levels
Measured: 12 weeks
Adverse events
Record and monitor any adverse events
Measured: Over 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2013 (estimated)
- Study start11 Nov 2013
- Primary completion1 Feb 2018
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GallbladderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- KGK Science Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Standard Process Inc.
- Responsible party
- Sponsor
- Investigators
- Tetyana Pelipyagina, MD, Principal investigator, KGK Science Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01981343
- Sponsor's protocol ID
- 12AGHS
- Status last verified
- Apr 2018
- First submitted
- 5 Nov 2013
- Last updated
- 11 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind, Placebo Controlled Parallel Study Evaluating the Effect of A-F Betafood® on Gallbladder and Liver Function.
- ClinicalTrials.gov ID
- NCT01981343
- Acronym / sponsor ID
- 12AGHS
- Conditions
- Gallbladder
- Keywords
- Gallbladder motility, A-F Betafood, Betaine, Ejection fraction, Ejection rate, Ultrasound
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- KGK Science Inc.Industry (pharma, biotech, devices)
- Collaborators
- Standard Process Inc.
- Study start
- 11 Nov 2013 (actual)
- Primary completion
- 1 Feb 2018 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 11 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A-F Betafood | Experimental | Dietary Supplement: A-F BetafoodTwo A-F Betafood tablets taken with a meal, 3 times daily for 12 weeks |
| Placebo | Placebo comparator | Other: Placebo2 Placebo tablets taken with a meal, 3 times daily for 12 weeks |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A-F Betafood | Dietary supplement | A-F Betafood |
| Placebo | Other | Placebo |
Primary outcome
Gallbladder and Liver function
Time frame: 12 weeks
Changes in Gallbladder Ultrasound and Liver function tests (fasting serum AST, ALT, GGT and hsCRP)
11 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2018.
Related trials for Gallbladder
Not yet recruitingPhase 4
Effect of Prophylactic Dexamethasone vs Placebo on Airway Dimensions Assessed by Ultrasonography in Patients Undergoing Laparoscopic Cholecystectomy
Airway Edema, Postoperative Complications
Not yet recruitingPhase 3
Hepatic Arterial Infusion Chemotherapy Versus Capecitabine as Adjuvant Therapy for Resected Biliary Tract Cancer
Biliary Tract Cancer, Cholangiocarcinoma
Recruiting
Distance-Based Exercise to Preserve Function and Prevent Disability
Localized Malignant Solid Neoplasm, Anal Cancer
RecruitingPhase 2
A Study to Learn More About How Well Treatment With Sevabertinib (BAY 2927088) Tablets Works and How Safe it is in Participants Who Have a Solid Tumor With Mutations of the Human Epidermal Growth Factor Receptor 2 (HER2)
Advanced Solid Tumors, HER2 Mutation
Not yet recruitingPhase 1
Study of ACC-1898 in Adult Participants With Advanced Solid Tumors
Hepatocellular Carcinoma, Renal Cell Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tetyana Pelipyagina, MD principal investigator
KGK Science Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing A-F Betafood in people with Gallbladder, run by KGK Science Inc. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gallbladder and Liver function (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2018.