Trial Outcomes & Findings for Dietary Treatment Study of Pediatric NAFLD (NCT NCT02513121)
NCT ID: NCT02513121
Last Updated: 2020-01-28
Results Overview
The principal objective of this randomized and controlled pilot study is to evaluate whether 8 weeks of a low added sugar diet (\<3%) in boys with NAFLD will change liver fat % measured by MRI.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
40 participants
Primary outcome timeframe
Measurements done at baseline and week 8.
Results posted on
2020-01-28
Participant Flow
Children with NAFLD were recruited from two US academic clinical research centers (University of California, San Diego and Emory University)
Boys ages 11 - 16 with biopsy proven NAFLD were randomized
Participant milestones
| Measure |
Intervention Group
Low free sugar diet
|
Control Group
Habitual diet
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Dietary Treatment Study of Pediatric NAFLD
Baseline characteristics by cohort
| Measure |
Intervention Group
n=20 Participants
Low free sugar diet
|
Control Group
n=20 Participants
Habitual diet
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
12.8 Years
STANDARD_DEVIATION 1.8 • n=99 Participants
|
13.4 Years
STANDARD_DEVIATION 1.9 • n=107 Participants
|
13.0 Years
STANDARD_DEVIATION 1.9 • n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
40 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
18 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
38 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
16 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
31 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
20 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
40 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Measurements done at baseline and week 8.The principal objective of this randomized and controlled pilot study is to evaluate whether 8 weeks of a low added sugar diet (\<3%) in boys with NAFLD will change liver fat % measured by MRI.
Outcome measures
| Measure |
Intervention Group
n=20 Participants
Low free sugar diet
|
Control Group
n=20 Participants
Habitual diet
|
|---|---|---|
|
Change in Percentage of Liver Fat Measured by Magnetic Resonance Imaging (MRI) in the Intervention Group Compared to Change in the Control Group
Baseline
|
22.9 Percentage of liver fat
Interval 18.7 to 28.0
|
19.4 Percentage of liver fat
Interval 16.2 to 23.2
|
|
Change in Percentage of Liver Fat Measured by Magnetic Resonance Imaging (MRI) in the Intervention Group Compared to Change in the Control Group
Week 8
|
14.9 Percentage of liver fat
Interval 11.4 to 19.6
|
18.0 Percentage of liver fat
Interval 14.0 to 22.4
|
SECONDARY outcome
Timeframe: Measurements done at baseline and week 8Outcome measures
| Measure |
Intervention Group
n=20 Participants
Low free sugar diet
|
Control Group
n=20 Participants
Habitual diet
|
|---|---|---|
|
Change in Alanine Aminotransferase (ALT) From Baseline to Week 8
Baseline
|
103.3 U/L
Interval 79.7 to 133.8
|
81.8 U/L
Interval 63.2 to 106.0
|
|
Change in Alanine Aminotransferase (ALT) From Baseline to Week 8
Week 8
|
61.3 U/L
Interval 46.1 to 81.3
|
75.2 U/L
Interval 56.7 to 99.9
|
SECONDARY outcome
Timeframe: Measurements doen at baseline and week 8Outcome measures
| Measure |
Intervention Group
n=20 Participants
Low free sugar diet
|
Control Group
n=20 Participants
Habitual diet
|
|---|---|---|
|
Change in Aspartate Aminotransferase (AST) From Baseline to Week 8
Baseline
|
52.0 U/L
Interval 39.5 to 68.4
|
43.6 U/L
Interval 33.2 to 57.4
|
|
Change in Aspartate Aminotransferase (AST) From Baseline to Week 8
Week 8
|
34.5 U/L
Interval 27.3 to 43.6
|
39.1 U/L
Interval 31.0 to 49.4
|
SECONDARY outcome
Timeframe: Measurements done at baseline and week 8Outcome measures
| Measure |
Intervention Group
n=20 Participants
Low free sugar diet
|
Control Group
n=20 Participants
Habitual diet
|
|---|---|---|
|
Change in Gamma-Glutamyl Transpeptidase (GGT) From Baseline to Week 8
Baseline
|
44.3 U/L
Interval 33.5 to 58.6
|
44.1 U/L
Interval 33.4 to 58.4
|
|
Change in Gamma-Glutamyl Transpeptidase (GGT) From Baseline to Week 8
Week 8
|
33.0 U/L
Interval 26.1 to 41.6
|
42.8 U/L
Interval 33.9 to 54.0
|
SECONDARY outcome
Timeframe: Measurements done at baseline and week 8Outcome measures
| Measure |
Intervention Group
n=19 Participants
Low free sugar diet
|
Control Group
n=19 Participants
Habitual diet
|
|---|---|---|
|
Change in Insulin From Baseline to Week 8
Baseline
|
38.4 mg/dL
Interval 28.6 to 51.6
|
41.8 mg/dL
Interval 31.2 to 56.0
|
|
Change in Insulin From Baseline to Week 8
Week 8
|
37.7 mg/dL
Interval 29.5 to 48.2
|
43.8 mg/dL
Interval 34.5 to 55.5
|
SECONDARY outcome
Timeframe: Measurements done at baseline and week 8HOMA-IR was calculated as follows: fasting insulin (µU/mL) x fasting glucose (nmol/L)/22.5
Outcome measures
| Measure |
Intervention Group
n=19 Participants
Low free sugar diet
|
Control Group
n=19 Participants
Habitual diet
|
|---|---|---|
|
Change in Homeostasis Model Assessment- Insulin Resistance (HOMA-IR) From Baseline to Week 8
Baseline
|
8.6 HOMA score
Interval 6.3 to 11.9
|
9.2 HOMA score
Interval 6.7 to 12.7
|
|
Change in Homeostasis Model Assessment- Insulin Resistance (HOMA-IR) From Baseline to Week 8
Week 8
|
7.7 HOMA score
Interval 5.9 to 10.0
|
10.2 HOMA score
Interval 7.9 to 13.1
|
SECONDARY outcome
Timeframe: Measurements done at baseline and week 8Outcome measures
| Measure |
Intervention Group
n=20 Participants
Low free sugar diet
|
Control Group
n=20 Participants
Habitual diet
|
|---|---|---|
|
Change in Triglycerides From Baseline to Week 8
Baseline
|
121.7 mg/dL
Interval 96.7 to 153.2
|
138.9 mg/dL
Interval 110.3 to 174.8
|
|
Change in Triglycerides From Baseline to Week 8
Week 8
|
104.1 mg/dL
Interval 82.6 to 131.3
|
134.3 mg/dL
Interval 106.5 to 169.4
|
Adverse Events
Intervention Group
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Control Group
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Intervention Group
n=20 participants at risk
Low free sugar diet
|
Control Group
n=20 participants at risk
Habitual diet
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
5.0%
1/20 • Adverse event details were collected throughout the duration of study participation, from the Baseline visit through the Week 8 follow up visit.
For this study, an adverse event is considered any untoward medical occurrence in a subject participating in a clinical study that does not necessarily have a causal relationship with the dietary intervention.
|
0.00%
0/20 • Adverse event details were collected throughout the duration of study participation, from the Baseline visit through the Week 8 follow up visit.
For this study, an adverse event is considered any untoward medical occurrence in a subject participating in a clinical study that does not necessarily have a causal relationship with the dietary intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Persistant Cough
|
5.0%
1/20 • Adverse event details were collected throughout the duration of study participation, from the Baseline visit through the Week 8 follow up visit.
For this study, an adverse event is considered any untoward medical occurrence in a subject participating in a clinical study that does not necessarily have a causal relationship with the dietary intervention.
|
0.00%
0/20 • Adverse event details were collected throughout the duration of study participation, from the Baseline visit through the Week 8 follow up visit.
For this study, an adverse event is considered any untoward medical occurrence in a subject participating in a clinical study that does not necessarily have a causal relationship with the dietary intervention.
|
|
Musculoskeletal and connective tissue disorders
Sprained Ankle
|
0.00%
0/20 • Adverse event details were collected throughout the duration of study participation, from the Baseline visit through the Week 8 follow up visit.
For this study, an adverse event is considered any untoward medical occurrence in a subject participating in a clinical study that does not necessarily have a causal relationship with the dietary intervention.
|
5.0%
1/20 • Adverse event details were collected throughout the duration of study participation, from the Baseline visit through the Week 8 follow up visit.
For this study, an adverse event is considered any untoward medical occurrence in a subject participating in a clinical study that does not necessarily have a causal relationship with the dietary intervention.
|
Additional Information
Dr. Jeffrey Schwimmer
University of California, San Diego
Phone: 858-966-8907
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place