None listed
Conditions
Brief summary
Cardiovascular disease (CVD) is one of the leading causes of mortality in developed countries accounting for as many as 12 million deaths per year. Many risk factors contribute to the development of CVD, a number of which are modifiable such as obesity, blood pressure and lipid profile (Expert Panel on Detection 1993; Grundy 2002). A number of dietary components have been shown to improve serum cholesterol levels in both animal and human studies. The most consistent and positive relationship is between intake of lipids and CVD risk, where intake of dietary saturated fats is closely associated with adverse serum cholesterol levels and increased CVD mortality (Hegsted, McGandy et al. 1965; Keys 1970; McGee, Reed et al. 1984; Kushi, Lew et al. 1985; Grundy and Vega 1988; Posner, Cobb et al. 1991; Caggiula and Mustad 1997; Poppitt, Keogh et al. 2002). Less is known of cholesterol-lowering effects of protein or protein fractions. Animal studies carried out by our research team have identified a number of milk proteins which may have significant cholesterol-lowering effects in humans. In particular, the dairy protein fraction casein hydrolysed using a peptic hydrolysate was shown to improve total cholesterol in a study of Apo E deficient mice.
Interventions
This was a double blind, randomised, placebo controlled, cross-over, out-patient trial in a group of 25 mildly hypercholesterolaemic male volunteers aged 18 - 70 years. Participants were randomised to receive either the active treatment or placebo for a period of 3 weeks, followed by a minimum washout period of 3 weeks, and were then crossed-over onto the second 3 week period of active treatment or placebo.
Participants came to the Human Nutrition Unit (HNU) on 7 occasions. At the first visit (
This was a double blind, randomised, placebo controlled, cross-over, out-patient trial in a group of 25 mildly hypercholesterolaemic male volunteers aged 18 - 70 years. Participants were randomised to receive either the active treatment or placebo for a period of 3 weeks, followed by a minimum washout period of 3 weeks, and were then crossed-over onto the second 3 week period of active treatment or placebo. Participants came to the Human Nutrition Unit (HNU) on 7 occasions. At the first visit (visit 1) they gave their informed consent and were registered to the study. At this visit the participant’s height, weight and blood pressure were measured and fasting blood and urine samples were taken for analyses. Information concerning medications and their medical history was recorded. Both treatment arms followed the same protocol. At visits 2 and 3 (days 0, 1; baseline) weight and blood pressure were measured and baseline fasting blood and urine samples were collected. Adverse events and changes in medications were recorded if applicable. Participants were given a week’s supply of treatment or placebo at visit 2 (depending on the randomization) to be taken daily. At visits 4 - 7 (days 7, 14, 21, 22) compliance to the treatment/placebo was checked, weight and blood pressure were measured, a fasting blood sample was collected and adverse events and changed in medications were recorded. At visit 22 a fasting urine sample was also collected. Treatments: The active treatment was a dairy-derived peptic casein hydrolysate, at a dose of 10g/day (=0.42MJ) The placebo was a dairy-derived whey protein control, at a matched dose of 10g/day (=0.42MJ) The treatments were administered as 1000mg capsules. 10 capsules were to be taken orally daily with breakfast.
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. mild hypercholesterolaemia; fasted LDL-C > 3.0 mmol/L 2. no clinical intervention or drug treatment for hyperlipidaemia 3. no previous cardiovascular events 4. no evidence of end organ damage 5. willingness to participate in a clinical trial
Exclusion criteria
1. allergy to milk or dairy products 2. treatment for lipid disorders 3. treatment for hypertension 4. significant metabolic disorders, including diabetes mellitus, significant renal impairment (serum creatinine>130mmol/L; EGFR<60) or other disease 5. gout 6. participation in another clinical intervention trial
Outcome results
None listed