Back to resultsEffect of Probiotics or Berberine in Hepatic Steatosis Markers, Cardiometabolic and Microbiotic Profile in NAFL.
Primary Purpose
Non Alcoholic Fatty Liver, Obesity
Status
Recruiting
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Probiotic
Berberine
Placebo
Probiotc and Berberine
Sponsored by
About this trial
This is an interventional treatment trial for Non Alcoholic Fatty Liver focused on measuring NAFL; obesity; probiotics; berberine; microbiota;
Eligibility Criteria
Inclusion Criteria:
- age 40 to 60 years;
- women ≥1 year since last menstruation;
- body mass index (BMI): 27.0 kg/m2 to 34.9 kg/m2;
- abdominal obesity-related waist circumference > 80 cm (women) and >94 cm (men) (in accordance to International Diabetes Federation);
- stable body weight in the 3 months prior to the trial (permissible deviation is ± 3 kg);
- NAFL - diagnosed based on USG in accordance with PGE-NAFLD recommendation
Exclusion Criteria:
- history of following alternative diets within 3 months before the study;
- history of use of any dietary supplements in the 3 months before the study;
- history of intake of antibiotics, probiotics, prebiotics within 3 months before the study;
- secondary form of obesity, pharmacological treatment for obesity (in the 3 months before the study), history of bariatric surgery;
- another liver diseases: high risk of NASH (assessed on the FIB-4, according to the PGE-NAFLD recommendation), autoimmune hepatitis, hepatitis B and C, toxic hepatitis, cirrhosis, Wilson's disease, hemochromatosis;
- other gastrointestinal disorders, especially: IBD, celiac disease, gastritis and duodenitis, pancreatic disorders, gastrointestinal symptoms suggestive of IBS;
- clinically significant acute inflammatory process (elevated hsCRP);
- abnormal kidney function (GFR <60mL/min/1,73m2);
- T2D;
- dyslipidemia or hypertension - requiring the introduction and/or change of pharmacological treatment in the 6 months before the trial or during intervention;
- pump inhibitors, anticoagulants, drugs causing metabolic alteration, e.g., SFAs (second-generation antipsychotics);
- diseases requiring nutritional requirement and chronic supplementation;
- alcohol (>30g/d for men and >20g/d for women), nicotine or drug abuse;
- mental disorders, including eating disorders;
- cancer, autoimmune diseases;
- any other condition which may influence on final results of the study or pose a risk for subjects health.
Sites / Locations
- 2 Department of Treatment of Obesity, Metabolic Disorders and Clinical Dietetics, Poznań University of Medical Sciences,Recruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Placebo Comparator
Active Comparator
Arm Label
Probiotic
Berberine
Placebo
Probiotics and Berberine
Arm Description
Individuals receive Probiotics (9 strains: B. bifidum W23, B. lactis W51, B. lactis W52, L. acidophilus W37, L. brevis W63, L. casei W56, L. salivarius W24, Lactococcus lactis W19, and Lactococcus lactis W58) in dose: 1x109 colony forming units (CFU), daily, for 12 weeks. Intervention: Dietary Supplement: Probiotic
Individuals receive Berberine (Berberine hydrochloride 97% extract of Berberis aristata) in dose: 1500 mg/day, for 12 weeks. Intervention: Dietary Supplement: Berberine
Individuals receive placebo daily, for 3 months. Intervention: Dietary Supplement: Placebo
Individuals receive: Probiotics (9 strains: B. bifidum W23, B. lactis W51, B. lactis W52, L. acidophilus W37, L. brevis W63, L. casei W56, L. salivarius W24, Lactococcus lactis W19, and Lactococcus lactis W58) in dose: 1x109 colony forming units (CFU), daily and Berberine (Berberine hydrochloride 97% extract of Berberis aristata) in dose: 1500 mg/day, for 12 weeks. Intervention: Dietary Supplement: Probiotic and Berberine
Outcomes
Primary Outcome Measures
Changes in Fibrosis-4 (FIB-4) - Index for Liver Fibrosis.
FIB-4 will be estimated using a medical calculator (based on parameters as: age, ALT, AST, and platelet count).
Changes in HSI - Hepatic Steatosis Index.
HSI will be estimated using a medical calculator (based on parameters as: gender, ALT, AST, BMI, and type 2 diabetes).
Changes in NAFLD-LFS (liver fat score).
NAFLD-LFS will be estimated using a medical calculator (based on serum aspartate transaminase/alanine transaminase (AST/ALT) ratio, fasting serum aspartate transaminase (AST) level, fasting serum insulin level, presence of metabolic syndrome and diabetes mellitus).
Secondary Outcome Measures
Changes in blood pressure.
Resting seated BP (both systolic and diastolic) will be measured using a brachial cuff (Omron Healthcare, Kyoto, Japan) three times at 2-min intervals, and the average value will be calculated.
Changes in weight.
Weight will be measured in light clothing and without metal objects (i.e., belt, jewelry). Weight will be measured to the nearest 0.1 kg.
Changes in waist circumference, hip circumference.
WC will be measured between the iliac crest and the lower rib at the end of a normal expiration, and HC will be measured around the widest portion of the buttocks. Both HC and WC will be measured using stretch-resistant medical tape (Seco) to the nearest 0.5 cm. The measurement of WC and HC will be performed according to the World Health Organization (WHO) protocol.
Changes in waist to hip ratio.
WHR will be calculated as WC to HC quotient.
Changes in BMI.
BMI will be calculated according to the formula: BMI = kg/m2 where kg is a person's weight in kilograms and m2 is their height in meters squared.
Changes in fat mass content in the body.
The fat mass content [in kg] in the body will be estimated using BIA methods (InBody 270 and Bioscan 920-2),
Changes in pulse wave velocity (PWV).
The pulse wave velocity (PWV) will be measured using the SphygmoCor Px (Atcor Medical Blood Pressure Analysis System, Sydney, Australia) in a temperature-controlled room before making anthropometric measurements and blood collection.
Changes in pulse wave analysis (PWA).
The pulse wave analysis (PWA)will be measured using the SphygmoCor Px (Atcor Medical Blood Pressure Analysis System, Sydney, Australia) in a temperature-controlled room before making anthropometric measurements and blood collection.
Gut (taxonomic and functional) microbiota analysis in stool.
Analyzed by the NGS method.
Short-chain fatty acids (SCFAs) concentration in stool.
Analyzed using gas chromatography (Agilent Technologies 1260 A GC system with a flame ionization detector (FID))
Measurement of hair minerals (Fe, Mg, Ca, Cu, Zn) concentration.
Performed using atomic absorption spectrometry (Atomic Absorption Spectrophotometer ZA3000, Hitachi, Tokyo, Japan)
Changes in ALT, AST, GGT
The ALT, AST, GGT will be measured using standard methods.
Changes in non-esterified free fatty acids.
The NEFA will be measured using standard methods.
Changes in lipids profile (TC, HDL, TG).
The TC, HDL, TG will be measured using standard methods.
Changes in low-density lipoprotein (LDL).
The low-density lipoprotein cholesterol (LDL) will be calculated according to the Friedwald equation.
Changes in fasting glucose level.
The fasting glucose level will be measured using standard methods.
Changes in fasting insulin level.
The ELISA will be used in the estimation.
Changes in insulin resistance index (HOMA-IR)
The HOMA-IR will be calculated according to formula:
HOMA-IR = (insulin * glucose) / 22.5 for the glucose concentration in mmol/L, or: HOMA-IR = (insulin * glucose ) / 405 for glycemia in mg/dL. In both cases, the insulin is in mU/L.
Changes in parameter of liver damage: cytokeratin 18.
The ELISA will be used in the estimation cytokeratin 18 (ccK18).
Changes in parameter of liver damage: Glutathione S-transferase (GST).
The ELISA will be used in the estimation GST.
Changes in parameter of liver damage: collagen IV.
The ELISA will be used in the estimation collagen IV.
Changes in parameter of liver damage: hyaluronic acid.
The ELISA will be used in the estimation hyaluronic acid.
Changes in hsCRP.
The hsCRP will be measured using ELISA.
Changes in pentraxin 3.
The pentraxin 3 (PTX3) will be measured using ELISA.
Gut barrier integrity parameter: calprotectin.
The ELISA, will be used in the estimation.
Gut barrier integrity parameters: liver fatty acid-binding protein (L-FABP), intestinal fatty acid-binding protein (I-FABP).
The ELISA, will be used in the estimation.
Gut barrier integrity parameters: lipopolysaccharide (LPS).
The ELISA, will be used in the estimation.
Cardiometabolic risk.
Cardiometabolic risk will be estimated at baseline and after 3 months of treatment using the SCORE scale. SCORE scale summarize 5 risk factors (sex, age, systolic blood pressure, total cholesterol and smoking).
Full Information
NCT ID
NCT05523024
First Posted
April 25, 2022
Last Updated
August 29, 2022
Sponsor
Poznan University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT05523024
Brief Title
Effect of Probiotics or Berberine in Hepatic Steatosis Markers, Cardiometabolic and Microbiotic Profile in NAFL.
Official Title
Effect of Probiotics or Berberine Supplementation on Hepatic Steatosis Markers, Cardiometabolic and Microbiotic Profile in NAFL - A Randomized Double- Blind Clinical Study.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 2, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
June 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Poznan University of Medical Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Effect of oral selected Probiotics (PRO) and/or Berberine (BBR) supplementation on hepatic steatosis markers, cardiometabolic profile, and gut microbiota profile in the non-alcoholic fatty liver (NAFL) - a randomized double-blind clinical study.
Detailed Description
Probiotics (PRO) and bioactive natural substances such as Berberine (BBR) can improve metabolic parameters in patients with obesity and metabolic disorders. In addition, they significantly affect the composition and function of gut microbiota (GM) and support anti-inflammation and antioxidant defense. These data have become the starting point for the proposed multidirectional approach, aimed at assessing the effect of PRO and/or BBR supplementation on:
hepatic-related outcomes,
changes in anthropometric measurements (body mass, BMI, body mass composition and fat mass % content),
cardiometabolic profile (e.g. blood pressure, noninvasive markers of endothelial function, cardiometabolic biochemical parameters)
microbiotic profile (gut microbiota composition, endotoxemia)
the content of the minerals, in overweight/obese patients with nonalcoholic fatty liver (NAFL).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Alcoholic Fatty Liver, Obesity
Keywords
NAFL; obesity; probiotics; berberine; microbiota;
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
140 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Probiotic
Arm Type
Active Comparator
Arm Description
Individuals receive Probiotics (9 strains: B. bifidum W23, B. lactis W51, B. lactis W52, L. acidophilus W37, L. brevis W63, L. casei W56, L. salivarius W24, Lactococcus lactis W19, and Lactococcus lactis W58) in dose: 1x109 colony forming units (CFU), daily, for 12 weeks.
Intervention: Dietary Supplement: Probiotic
Arm Title
Berberine
Arm Type
Active Comparator
Arm Description
Individuals receive Berberine (Berberine hydrochloride 97% extract of Berberis aristata) in dose: 1500 mg/day, for 12 weeks.
Intervention: Dietary Supplement: Berberine
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Individuals receive placebo daily, for 3 months. Intervention: Dietary Supplement: Placebo
Arm Title
Probiotics and Berberine
Arm Type
Active Comparator
Arm Description
Individuals receive: Probiotics (9 strains: B. bifidum W23, B. lactis W51, B. lactis W52, L. acidophilus W37, L. brevis W63, L. casei W56, L. salivarius W24, Lactococcus lactis W19, and Lactococcus lactis W58) in dose: 1x109 colony forming units (CFU), daily and Berberine (Berberine hydrochloride 97% extract of Berberis aristata) in dose: 1500 mg/day, for 12 weeks.
Intervention: Dietary Supplement: Probiotic and Berberine
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotic
Intervention Description
The probiotic group will receive one capsule of the probiotic mixture (dose:1x109 colony forming units (CFU) per day in one dose (before breakfast). The PRO preparation will contain the following bacterial strains: 50% Lactococcus lactis Rosell® - 1058, 25% Lactobacillus casei Rosell® - 215, 12,5% Lactobacillus helveticus Rosell® - 52, 12,5% Bifidobacterium bifidum Rosell® - 71). Probiotics will be administered orally.
Intervention Type
Dietary Supplement
Intervention Name(s)
Berberine
Intervention Description
The berberine group will receive 1500 mg of Berberine (Berberine hydrochloride 97% extract of Berberis aristata) per day in 3 doses. Berberine will be administered orally, before breakfast, dinner, and before supper.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
The placebo group will receive a placebo. Placebo will contain only the excipients and will be administered orally for 24 weeks. Placebo in no way: color, taste, smell, form of taking, the dosage will not differ from the preparations tested. However, it will not contain probiotcs or berberine. Placebo will be orally administered three times a day: before breakfast, dinner, and supper (6.00-7.00 p.m.). To meet the GCP conditions, subjects from all groups will receive the same number of capsules (six) per day.
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotc and Berberine
Intervention Description
Probiotics and Berberine groupwill receive both: a probiotics mixture (as in PRO group: 1x109 CFU/day; in one dose) and 1500 mg/day of Berberine (Berberine hydrochloride 97% extract of Berberis aristata; in 3 doses). Probiotcs and berberine will be administered orally before breakfast, before dinner, and before supper.
Primary Outcome Measure Information:
Title
Changes in Fibrosis-4 (FIB-4) - Index for Liver Fibrosis.
Description
FIB-4 will be estimated using a medical calculator (based on parameters as: age, ALT, AST, and platelet count).
Time Frame
At the baseline and 12 weeks of treatment
Title
Changes in HSI - Hepatic Steatosis Index.
Description
HSI will be estimated using a medical calculator (based on parameters as: gender, ALT, AST, BMI, and type 2 diabetes).
Time Frame
At the baseline and 12 weeks of treatment
Title
Changes in NAFLD-LFS (liver fat score).
Description
NAFLD-LFS will be estimated using a medical calculator (based on serum aspartate transaminase/alanine transaminase (AST/ALT) ratio, fasting serum aspartate transaminase (AST) level, fasting serum insulin level, presence of metabolic syndrome and diabetes mellitus).
Time Frame
At the baseline and 12 weeks of treatment
Secondary Outcome Measure Information:
Title
Changes in blood pressure.
Description
Resting seated BP (both systolic and diastolic) will be measured using a brachial cuff (Omron Healthcare, Kyoto, Japan) three times at 2-min intervals, and the average value will be calculated.
Time Frame
At the baseline and 12 weeks of treatment
Title
Changes in weight.
Description
Weight will be measured in light clothing and without metal objects (i.e., belt, jewelry). Weight will be measured to the nearest 0.1 kg.
Time Frame
At the baseline and 12 weeks of treatment
Title
Changes in waist circumference, hip circumference.
Description
WC will be measured between the iliac crest and the lower rib at the end of a normal expiration, and HC will be measured around the widest portion of the buttocks. Both HC and WC will be measured using stretch-resistant medical tape (Seco) to the nearest 0.5 cm. The measurement of WC and HC will be performed according to the World Health Organization (WHO) protocol.
Time Frame
At the baseline and 12 weeks of treatment
Title
Changes in waist to hip ratio.
Description
WHR will be calculated as WC to HC quotient.
Time Frame
At the baseline and 12 weeks of treatment
Title
Changes in BMI.
Description
BMI will be calculated according to the formula: BMI = kg/m2 where kg is a person's weight in kilograms and m2 is their height in meters squared.
Time Frame
At the baseline and 12 weeks of treatment
Title
Changes in fat mass content in the body.
Description
The fat mass content [in kg] in the body will be estimated using BIA methods (InBody 270 and Bioscan 920-2),
Time Frame
At the baseline and 12 weeks of treatment
Title
Changes in pulse wave velocity (PWV).
Description
The pulse wave velocity (PWV) will be measured using the SphygmoCor Px (Atcor Medical Blood Pressure Analysis System, Sydney, Australia) in a temperature-controlled room before making anthropometric measurements and blood collection.
Time Frame
At the baseline and 12 weeks of treatment
Title
Changes in pulse wave analysis (PWA).
Description
The pulse wave analysis (PWA)will be measured using the SphygmoCor Px (Atcor Medical Blood Pressure Analysis System, Sydney, Australia) in a temperature-controlled room before making anthropometric measurements and blood collection.
Time Frame
At the baseline and 12 weeks of treatment
Title
Gut (taxonomic and functional) microbiota analysis in stool.
Description
Analyzed by the NGS method.
Time Frame
At the baseline and 12 weeks of treatment
Title
Short-chain fatty acids (SCFAs) concentration in stool.
Description
Analyzed using gas chromatography (Agilent Technologies 1260 A GC system with a flame ionization detector (FID))
Time Frame
At the baseline and 12 weeks of treatment
Title
Measurement of hair minerals (Fe, Mg, Ca, Cu, Zn) concentration.
Description
Performed using atomic absorption spectrometry (Atomic Absorption Spectrophotometer ZA3000, Hitachi, Tokyo, Japan)
Time Frame
At the baseline and 12 weeks of treatment
Title
Changes in ALT, AST, GGT
Description
The ALT, AST, GGT will be measured using standard methods.
Time Frame
At the baseline and 12 weeks of treatment
Title
Changes in non-esterified free fatty acids.
Description
The NEFA will be measured using standard methods.
Time Frame
At the baseline and 12 weeks of treatment
Title
Changes in lipids profile (TC, HDL, TG).
Description
The TC, HDL, TG will be measured using standard methods.
Time Frame
At the baseline and 12 weeks of treatment
Title
Changes in low-density lipoprotein (LDL).
Description
The low-density lipoprotein cholesterol (LDL) will be calculated according to the Friedwald equation.
Time Frame
At the baseline and 12 weeks of treatment
Title
Changes in fasting glucose level.
Description
The fasting glucose level will be measured using standard methods.
Time Frame
At the baseline and 12 weeks of treatment
Title
Changes in fasting insulin level.
Description
The ELISA will be used in the estimation.
Time Frame
At the baseline and 12 weeks of treatment
Title
Changes in insulin resistance index (HOMA-IR)
Description
The HOMA-IR will be calculated according to formula:
HOMA-IR = (insulin * glucose) / 22.5 for the glucose concentration in mmol/L, or: HOMA-IR = (insulin * glucose ) / 405 for glycemia in mg/dL. In both cases, the insulin is in mU/L.
Time Frame
At the baseline and 12 weeks of treatment
Title
Changes in parameter of liver damage: cytokeratin 18.
Description
The ELISA will be used in the estimation cytokeratin 18 (ccK18).
Time Frame
At the baseline and 12 weeks of treatment
Title
Changes in parameter of liver damage: Glutathione S-transferase (GST).
Description
The ELISA will be used in the estimation GST.
Time Frame
At the baseline and 12 weeks of treatment
Title
Changes in parameter of liver damage: collagen IV.
Description
The ELISA will be used in the estimation collagen IV.
Time Frame
At the baseline and 12 weeks of treatment
Title
Changes in parameter of liver damage: hyaluronic acid.
Description
The ELISA will be used in the estimation hyaluronic acid.
Time Frame
At the baseline and 12 weeks of treatment
Title
Changes in hsCRP.
Description
The hsCRP will be measured using ELISA.
Time Frame
At the baseline and 12 weeks of treatment
Title
Changes in pentraxin 3.
Description
The pentraxin 3 (PTX3) will be measured using ELISA.
Time Frame
At the baseline and 12 weeks of treatment
Title
Gut barrier integrity parameter: calprotectin.
Description
The ELISA, will be used in the estimation.
Time Frame
At the baseline and 12 weeks of treatment
Title
Gut barrier integrity parameters: liver fatty acid-binding protein (L-FABP), intestinal fatty acid-binding protein (I-FABP).
Description
The ELISA, will be used in the estimation.
Time Frame
At the baseline and 12 weeks of treatment
Title
Gut barrier integrity parameters: lipopolysaccharide (LPS).
Description
The ELISA, will be used in the estimation.
Time Frame
At the baseline and 12 weeks of treatment
Title
Cardiometabolic risk.
Description
Cardiometabolic risk will be estimated at baseline and after 3 months of treatment using the SCORE scale. SCORE scale summarize 5 risk factors (sex, age, systolic blood pressure, total cholesterol and smoking).
Time Frame
At the baseline and 12 weeks of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age 40 to 60 years;
women ≥1 year since last menstruation;
body mass index (BMI): 27.0 kg/m2 to 34.9 kg/m2;
abdominal obesity-related waist circumference > 80 cm (women) and >94 cm (men) (in accordance to International Diabetes Federation);
stable body weight in the 3 months prior to the trial (permissible deviation is ± 3 kg);
NAFL - diagnosed based on USG in accordance with PGE-NAFLD recommendation
Exclusion Criteria:
history of following alternative diets within 3 months before the study;
history of use of any dietary supplements in the 3 months before the study;
history of intake of antibiotics, probiotics, prebiotics within 3 months before the study;
secondary form of obesity, pharmacological treatment for obesity (in the 3 months before the study), history of bariatric surgery;
another liver diseases: high risk of NASH (assessed on the FIB-4, according to the PGE-NAFLD recommendation), autoimmune hepatitis, hepatitis B and C, toxic hepatitis, cirrhosis, Wilson's disease, hemochromatosis;
other gastrointestinal disorders, especially: IBD, celiac disease, gastritis and duodenitis, pancreatic disorders, gastrointestinal symptoms suggestive of IBS;
clinically significant acute inflammatory process (elevated hsCRP);
abnormal kidney function (GFR <60mL/min/1,73m2);
T2D;
dyslipidemia or hypertension - requiring the introduction and/or change of pharmacological treatment in the 6 months before the trial or during intervention;
pump inhibitors, anticoagulants, drugs causing metabolic alteration, e.g., SFAs (second-generation antipsychotics);
diseases requiring nutritional requirement and chronic supplementation;
alcohol (>30g/d for men and >20g/d for women), nicotine or drug abuse;
mental disorders, including eating disorders;
cancer, autoimmune diseases;
any other condition which may influence on final results of the study or pose a risk for subjects health.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Małgorzata Moszak, PhD
Phone
+48-6185-49-377
Email
mmoszak@ump.edu.pl
First Name & Middle Initial & Last Name or Official Title & Degree
Monika Szulińska, DSc
Phone
+48-6185-49-377
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paweł Bogdański, Professor
Organizational Affiliation
Poznan University of Medical Sciences, Poznan, Poland
Official's Role
Principal Investigator
Facility Information:
Facility Name
2 Department of Treatment of Obesity, Metabolic Disorders and Clinical Dietetics, Poznań University of Medical Sciences,
City
Poznań
ZIP/Postal Code
60-569
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Małgorzata Moszak, PhD
Phone
+48-6185-49-377
Email
mmoszak@ump.edu.pl
12. IPD Sharing Statement
Plan to Share IPD
No
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Effect of Probiotics or Berberine in Hepatic Steatosis Markers, Cardiometabolic and Microbiotic Profile in NAFL.
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