None listed
Conditions
Brief summary
Metabolic syndrome (Met Syn) is the combination of metabolic disorders that increase the risk of developing CVD and Type 2 Diabetes Mellitus. The MetSyn cluster is characterized by central adiposity, adverse lipid and glucose profiles and hypertension (Alberti KG et al 2009). Other metabolic abnormalities that may be drivers of the events or develop in parallel include increases in pro-inflammatory profile, disordered blood clotting and lipid ‘overspill’ from adipose into critical organs such as liver, heart and muscle. Nonalcoholic fatty liver disease (NAFLD) or nonalcoholic steatohepatitis (NASH) are highly prevalent diseases that accompany obesity and the MetSyn (McKimmie RL et al 2008). A battery of in vitro investigations and preclinical rodent studies investigating the effect of bovine milk fractions on metabolic syndrome outcomes has led to the selection of 2 milk fractions to be taken forwards into clinical investigation for the treatment of obesity-related metabolic dysregulation. The in vitro and preclinical studies have been conducted by a collaborative group of researchers working within the LactoPharma NZ consortium, a joint venture between the NZ Foundation of Research Science & Technology (FRST) and dairy company Fonterra Co-Operative Group.
Interventions
This study will investigate the potential of two dairy derived extracts to improve symptoms of the Metabolic Syndrome, including fatty liver, serum lipid and glucose profiles & markers of inflammation, in individuals with the Metabolic Syndrome. The target population would be individuals identified as overweight with central adiposity, metabolic syndrome, abnormal liver function and fatty liver as shown by an ultrasound scan.
Participants will be randomised to recieve one of the 2 dairy fracti
This study will investigate the potential of two dairy derived extracts to improve symptoms of the Metabolic Syndrome, including fatty liver, serum lipid and glucose profiles & markers of inflammation, in individuals with the Metabolic Syndrome. The target population would be individuals identified as overweight with central adiposity, metabolic syndrome, abnormal liver function and fatty liver as shown by an ultrasound scan. Participants will be randomised to recieve one of the 2 dairy fractions or a control for a period of 3 weeks, followed by a minimum 3 weeks wash out period between active treatments or control. All participants will complete the three treatment arms. The dairy fractions differ from each other in that one is a high-carbohydrate fraction while the other is a high-lipid (fat) fraction. The dose of the carbohydrate fraction is 10g/day (138kJ) while the dose of the lipid fraction is 4g/day (138kJ). The doses were selected so as to match treatments for total energy (kJ). The dose of the control treatment is 6.5g/day (138kJ). The administration vehicle for this study will be a chocolate dairy dessert. All treatments will be incorporated into 150g fresh dessert and consumed daily.
Sponsors
LactoPharma
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
Male
Age
18 Years to 70 Years
Healthy volunteers
No
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
Outcome results
None listed