Trial Outcomes & Findings for Efficacy of a Natural Components Mixture in the Treatment of Non Alcoholic Fatty Liver Disease (NAFLD) (NCT NCT02369536)
NCT ID: NCT02369536
Last Updated: 2022-01-12
Results Overview
hematic levels of hepatic enzyme: aspartate aminotransferase (AST)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
126 participants
Primary outcome timeframe
before and at the end of treatment (three months)
Results posted on
2022-01-12
Participant Flow
Participant milestones
| Measure |
Nutraceutical Mixture
Lifestyle counseling plus three month administration of nutraceutical mixture (2 soft gelatin capsules of 800 mg per day)
nutraceutical mixture: Lifestyle counseling, administration of a nutraceutical mixture: fish oil 70% DHA (docosahexaenoic acid), phosphatidylcholine concentrated in sunflower oil, silymarin, choline bitartrate, curcumin, D-α-tocopherol; choline (82,5 mg, corresponding to 15% of the average intake of 550 mg per day in an adult man)
|
Placebo
Lifestyle counseling plus three month administration of placebo formulation (2 soft gelatin capsules of 800 mg per day)
placebo: Lifestyle counseling, administration of a placebo, containing only choline, at the same low concentration of the active mixture
|
|---|---|---|
|
Overall Study
STARTED
|
62
|
64
|
|
Overall Study
COMPLETED
|
55
|
58
|
|
Overall Study
NOT COMPLETED
|
7
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Subjects lost at follow-up: 7 in the active group and 6 in the control group.
Baseline characteristics by cohort
| Measure |
Nutraceutical Mixture
n=55 Participants
Lifestyle counseling plus three month administration of nutraceutical mixture (2 soft gelatin capsules of 800 mg per day)
nutraceutical mixture: Lifestyle counseling, administration of a nutraceutical mixture: fish oil 70% DHA (docosahexaenoic acid), phosphatidylcholine concentrated in sunflower oil, silymarin, choline bitartrate, curcumin, D-α-tocopherol; choline (82,5 mg, corresponding to 15% of the average intake of 550 mg per day in an adult man)
|
Placebo
n=58 Participants
Lifestyle counseling plus three month administration of placebo formulation (2 soft gelatin capsules of 800 mg per day)
placebo: Lifestyle counseling, administration of a placebo, containing only choline, at the same low concentration of the active mixture
|
Total
n=113 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants • Subjects lost at follow-up: 7 in the active group and 6 in the control group.
|
0 Participants
n=7 Participants • Subjects lost at follow-up: 7 in the active group and 6 in the control group.
|
0 Participants
n=5 Participants • Subjects lost at follow-up: 7 in the active group and 6 in the control group.
|
|
Age, Categorical
Between 18 and 65 years
|
47 Participants
n=5 Participants • Subjects lost at follow-up: 7 in the active group and 6 in the control group.
|
47 Participants
n=7 Participants • Subjects lost at follow-up: 7 in the active group and 6 in the control group.
|
94 Participants
n=5 Participants • Subjects lost at follow-up: 7 in the active group and 6 in the control group.
|
|
Age, Categorical
>=65 years
|
8 Participants
n=5 Participants • Subjects lost at follow-up: 7 in the active group and 6 in the control group.
|
11 Participants
n=7 Participants • Subjects lost at follow-up: 7 in the active group and 6 in the control group.
|
19 Participants
n=5 Participants • Subjects lost at follow-up: 7 in the active group and 6 in the control group.
|
|
Age, Continuous
|
55.7 years
STANDARD_DEVIATION 12.2 • n=5 Participants • Subjects lost at follow-up: 7 in the active group, for: bone fracture (1), relocation to another city (1), discontinued supplementation for dermatitis (1), unmotivated personal decision (4); 6 in the control group, for: discontinued supplementation for faecal color abnormality (green faeces, 1), unmotivated personal decision (5)
|
53.4 years
STANDARD_DEVIATION 11.3 • n=7 Participants • Subjects lost at follow-up: 7 in the active group, for: bone fracture (1), relocation to another city (1), discontinued supplementation for dermatitis (1), unmotivated personal decision (4); 6 in the control group, for: discontinued supplementation for faecal color abnormality (green faeces, 1), unmotivated personal decision (5)
|
54.6 years
STANDARD_DEVIATION 11.8 • n=5 Participants • Subjects lost at follow-up: 7 in the active group, for: bone fracture (1), relocation to another city (1), discontinued supplementation for dermatitis (1), unmotivated personal decision (4); 6 in the control group, for: discontinued supplementation for faecal color abnormality (green faeces, 1), unmotivated personal decision (5)
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants • Subjects lost at follow-up: 7 in the active group and 6 in the control group.
|
19 Participants
n=7 Participants • Subjects lost at follow-up: 7 in the active group and 6 in the control group.
|
39 Participants
n=5 Participants • Subjects lost at follow-up: 7 in the active group and 6 in the control group.
|
|
Sex: Female, Male
Male
|
35 Participants
n=5 Participants • Subjects lost at follow-up: 7 in the active group and 6 in the control group.
|
39 Participants
n=7 Participants • Subjects lost at follow-up: 7 in the active group and 6 in the control group.
|
74 Participants
n=5 Participants • Subjects lost at follow-up: 7 in the active group and 6 in the control group.
|
|
Region of Enrollment
Italy
|
55 participants
n=5 Participants • Subjects lost at follow-up: 7 in the active group and 6 in the control group.
|
58 participants
n=7 Participants • Subjects lost at follow-up: 7 in the active group and 6 in the control group.
|
113 participants
n=5 Participants • Subjects lost at follow-up: 7 in the active group and 6 in the control group.
|
PRIMARY outcome
Timeframe: before and at the end of treatment (three months)hematic levels of hepatic enzyme: aspartate aminotransferase (AST)
Outcome measures
| Measure |
Nutraceutical Mixture
n=55 Participants
|
Placebo
n=58 Participants
|
|---|---|---|
|
Hematic Levels of Hepatic Enzymes AST
before treatment
|
35.4 IU/L
Standard Deviation 22.5
|
37.5 IU/L
Standard Deviation 25.2
|
|
Hematic Levels of Hepatic Enzymes AST
after 3 months
|
31.6 IU/L
Standard Deviation 15
|
31.2 IU/L
Standard Deviation 14.7
|
PRIMARY outcome
Timeframe: before and at the end of treatment (three months)hematic levels of hepatic enzyme: alanine aminotransferase (ALT)
Outcome measures
| Measure |
Nutraceutical Mixture
n=55 Participants
|
Placebo
n=58 Participants
|
|---|---|---|
|
Hematic Levels of Hepatic Enzymes ALT
before treatment
|
45.5 IU/L
Standard Deviation 28.4
|
48.3 IU/L
Standard Deviation 43.4
|
|
Hematic Levels of Hepatic Enzymes ALT
after 3 months
|
43.8 IU/L
Standard Deviation 22.9
|
40.0 IU/L
Standard Deviation 21.9
|
PRIMARY outcome
Timeframe: before and at the end of treatment (three months)hematic levels of hepatic enzyme: gamma-glutamyl transpeptidase (GGT)
Outcome measures
| Measure |
Nutraceutical Mixture
n=55 Participants
|
Placebo
n=58 Participants
|
|---|---|---|
|
Hematic Levels of Hepatic Enzymes GGT
after 3 months
|
87.2 IU/L
Standard Deviation 71.1
|
75.6 IU/L
Standard Deviation 64.4
|
|
Hematic Levels of Hepatic Enzymes GGT
before treatment
|
101.4 IU/L
Standard Deviation 101.0
|
98.5 IU/L
Standard Deviation 136.0
|
SECONDARY outcome
Timeframe: before and at the end of treatment (three months)Population: direct bilirubin
hematic levels of direct bilirubin
Outcome measures
| Measure |
Nutraceutical Mixture
n=55 Participants
|
Placebo
n=58 Participants
|
|---|---|---|
|
Plasma Levels of Hepatic Enzymes
before treatment
|
2.05 microM/L
Standard Deviation 1.2
|
2.74 microM/L
Standard Deviation 2.91
|
|
Plasma Levels of Hepatic Enzymes
3 months after
|
2.22 microM/L
Standard Deviation 1.2
|
2.39 microM/L
Standard Deviation 1.71
|
SECONDARY outcome
Timeframe: before and at the end of treatment (three months)Levels of circulating Inflammation marker: C Reactive Protein (CRP)
Outcome measures
| Measure |
Nutraceutical Mixture
n=55 Participants
|
Placebo
n=58 Participants
|
|---|---|---|
|
Levels of Circulating Inflammation Marker
before treatment
|
21.0 nmol/L
Interval 13.3 to 38.1
|
28.3 nmol/L
Interval 3.4 to 44.5
|
|
Levels of Circulating Inflammation Marker
3 months after
|
17.1 nmol/L
Interval 12.9 to 30.5
|
24.0 nmol/L
Interval 13.3 to 41.0
|
SECONDARY outcome
Timeframe: before and at the end of treatment (three months)Tissue-type Plasminogen Activator (t-PA) levels in plasma
Outcome measures
| Measure |
Nutraceutical Mixture
n=55 Participants
|
Placebo
n=58 Participants
|
|---|---|---|
|
Measures of the Haemostatic Function
after 3 months
|
8.7 ng/ml
Standard Deviation 4.9
|
9.9 ng/ml
Standard Deviation 8.9
|
|
Measures of the Haemostatic Function
before treatment
|
8.6 ng/ml
Standard Deviation 4.8
|
10.1 ng/ml
Standard Deviation 9.0
|
SECONDARY outcome
Timeframe: before and at the end of treatment (three months)Plasminogen Activator Inihibitor (PAI-1) levels in plasma
Outcome measures
| Measure |
Nutraceutical Mixture
n=55 Participants
|
Placebo
n=58 Participants
|
|---|---|---|
|
Measures of the Haemostatic Function
before treatment
|
42.7 ng/ml
Standard Deviation 19.8
|
48.0 ng/ml
Standard Deviation 18.5
|
|
Measures of the Haemostatic Function
after 3 months
|
44.3 ng/ml
Standard Deviation 18.4
|
47.7 ng/ml
Standard Deviation 21.9
|
SECONDARY outcome
Timeframe: before and at the end of treatment (three months)Thrombin activatable fibrinolysis inhibitor (TAFI) levels in plasma
Outcome measures
| Measure |
Nutraceutical Mixture
n=55 Participants
|
Placebo
n=58 Participants
|
|---|---|---|
|
Measures of the Haemostatic Function
before treatment
|
105 % of reference plasma
Standard Deviation 23
|
100 % of reference plasma
Standard Deviation 23
|
|
Measures of the Haemostatic Function
after 3 months
|
104 % of reference plasma
Standard Deviation 23
|
99 % of reference plasma
Standard Deviation 21
|
Adverse Events
Nutraceutical Mixture
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Chiara Cerletti, operative responsible of the trial and corresponding author of the data public
IRCCS Neuromed
Phone: 0865915246
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place