Milk fractions and metabolic syndrome markers

Not Applicable

Completed

• Conditions: Metabolic Syndrome; Diet and Nutrition - Obesity; Metabolic and Endocrine - Other metabolic disorders

• Registration Number: ACTRN12611000312943
• Lead Sponsor: actoPharma

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-03-24
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 30

Inclusion Criteria

1. Male gender
2. Age 18-70 years
3. BMI: >25 kg/m2
4. Central obesity (waist circumference >94 cm for Europeans or >90cm for Indian & Asian Ethnic groups).
5. Abnormal liver function tests as indicated by raised liver enzyme above normal range [normal range: AST 0-45 IU/L, ALT 0-45 IU/L, GGT 0-60 IU/L]
6. Plus any one of the following adverse metabolic syndrome markers [Triglyceride >1.7mmol/L; HDL- Cholesterol <1.03mmol/L; Glucose >5.4mmol/L;
Blood Pressure >130/85mmHg]
7. Fatty liver as determined by an ultrasound scan
8. Change in body weight of <10 kg within the past 6 months, as per self report.
9. Willingness to participate in a clinical trial

Exclusion Criteria

1. Allergy to milk or dairy products
2. Endocrine, cardiovascular, gastrointestinal (including liver), metabolic disease or cancer/s including prior history
3. Known hepatitis or other liver disease
4. Significant renal impairment based on serum creatinine >120umol/L, estimated Glomerular Filtration Rate (eGFR) < 60ml/min/1.73m2 , and raised microalbuminurea
5. Current treatment for metabolic disease including hypertension, hyperlipidemia, Type 2 Diabetes Mellitus and gout.
6. Alcohol intake exceeding >30g a day or >210g weekly (ie. >3 standard drinks a day or >21 standard drinks a week) indicative of alcoholic fatty liver disease
7. Unwilling/unable to comply with study protocol
8. Participation in another clinical intervention trial

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in blood markers of obesity-induced metabolic dysregulation: Fasting lipids [triacylglyceride (TAG), total cholesterol, low density lipoprotein cholecterol (LDL-C) & high density lipoprotein cholesterol (HDL-C)]. Blood samples will be collected via phlebotomy for analyses[At the end of each 3 week treatment period (day 21)]

Secondary Outcome Measures

Name	Time	Method
Changes in blood markers of liver function including Aspartate transaminase (AST), Alanine transaminase (ALT) & Gamma glutamyl transpeptidase (GGT). Blood samples will be collected via phlebotomy for analyses[At the end of each 3 week treatment period (day 21)];Fasting blood glucose & fasting insulin. Blood samples will be collected via phlebotomy for analyses[At the end of each 3 week treatment period (day 21)]