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The intervention effects of combination of omega-3 polyunsaturated fatty acid with phytosterol ester on nonalcoholic fatty liver disease

The intervention effects of combination of omega-3 polyunsaturated fatty acid with phytosterol ester on nonalcoholic fatty liver disease

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800014419
Enrollment
Unknown
Registered
2018-01-12
Start date
2018-01-20
Completion date
Unknown
Last updated
2018-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nonalcoholic fatty liver disease

Interventions

Intervention group 3:PSE fortified soybean milk powder (2satchel/d, 3.3g PSE) and fish oil (2g total omega-3,EPA: DHA ratio of 150:500 )
Control:regular soybean milk powder (2satchel/d) and vegetable oil capsule (6 capsules/d)
Intervention group 1:PSE fortified soybean milk powder (2satchel/d, 3.3g PSE) and vegetable oil capsule (6 capsules/d)
Intervention group 2:regular soybean milk powder (2satchel/d)and fish oil (2g total omega-3,EPA: DHA ratio of 150:500 )

Sponsors

Shanghai Jiao Tong University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Hyperlipidemia (TG > 1.70 mmol/L, or/and TC > 5.8 mmol, or/and LDL-c > 3.6 mmol/L); 2. Obesity or overweight (BMI greater than 24); 3. Symptom of fatty liver diagnosed with CT scanning; 4. Alcohol intake is minimal or never (women < 15g/d, men < 30g/d); 5. There are no other liver diseases except for the healthy subjects with NAFLD symptoms; 6. The subjects understand the information provided and is able to record the required data.

Exclusion criteria

Exclusion criteria: Diabetes, pregnant, cardiovascular disease, cancer, disabled, ?lactose intolerance, type of diabetes mellitus, subjects with excessive alcohol consumption (=30 g/d in men and =20 g/d in women) , hepatitis B or C or other liver diseases, or if they were receiving hypoglycemic or lipid-regulating (statins, fibrates) drugs, or other drugs that may impact glucose and lipid metabolism. Other exclusion factors were diseases affecting the metabolic state or not suitable to participate in this study, for example, hyperthyroidism, hypothyroidism, mental disease, serious disease with dysfunction of heart, liver, kidney, etc. All subjects underwent comprehensive physical examinations and routine biochemical analyses of blood.

Design outcomes

Primary

MeasureTime frame
liver steatosis degree;Blood lipid, blood sugar, liver function, kidney function;Level of the amino acids, fatty acids, etc;Body Mass Index;blood pressure;WHR;

Countries

China

Contacts

Public ContactSong Lihua

Shanghai Jiao Tong University

lihuas@sjtu.edu.cn+86 13661878429

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026