A Pilot Study in the Swiss Alps: Impact of Alpine Dairy Products on Blood Lipid Levels
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Fribourg
- Enrollment
- 29
- Locations
- 1
- Primary Endpoint
- Change in fasting blood LDL-cholesterol level
Study Overview
Brief Summary
Elevated blood lipid levels are one of the main risk factors for cardiovascular disease. To manage elevated blood lipid levels in otherwise healthy people at low risk of cardiovascular disease, lifestyle changes are recommended as the first treatment strategy. One of these changes concerns diet. Clinical observations by general practitioners in alpine regions of Switzerland have shown that consumption of dairy products produced from cows living and grazing at high altitudes can have a beneficial effect on blood lipid parameters. However, little clinical data is available on the effect of alpine dairy products on health-related markers. This pilot study aims to assess if replacing standard (non-alpine) dairy products by alpine dairy products in the daily diet among patients with elevated LDL-cholesterol levels could reduce the blood LDL-cholesterol levels.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age ≥18 years old
- •Elevated lipid levels, namely: fasting LDL-cholesterol >3mmol/L and </=5mmol/L
- •Agreeing to eat 3 portions of dairy products daily (according to instructions)
Exclusion Criteria
- •Eating less than two and more than six portions of dairy products daily
- •Body weight change +/-5% of body weight in the last three months
- •Secondary prevention treatment for cardiovascular disease
- •Moderate, high or very high cardiovascular risk according to AGLA score
- •Currently taking PSCK9-inhibitors, ezetimibe, statins, glucocorticoids
- •Poorly controlled, severe chronic renal insufficiency, hypothyroidism, cholestasis, nephrotic syndrome, eating disorders, alcohol abuse, Cushing syndrome
- •Myocardial infarction, percutaneous coronary intervention or coronary artery bypass grafting in the previous 6 months
- •Known lactose intolerance or dairy allergies
- •Change of diet less than 2 months before intervention
- •Pregnant or breastfeeding
- •Incapacity of judgement
- •Inability to speak and read German
Arms & Interventions
Alpine dairy products
Intake of 3 portions of alpine dairy products made from milk of cows grazing in subalpine to alpine regions in the Swiss alps in Val Müstair (GR) (one portion equals 2 dl milk, 150-200 g yoghurt, quark, cottage cheese, other dairy products, 30g hard cheese, 60g soft cheese) during the 6-week intervention period. Every dairy product intake will be reported into the participants' food log. Participants will be instructed not to change their diet (with the exception of dairy products), lifestyle and physical activity during the study.
Intervention: Alpine dairy products (Other)
Non-alpine dairy products
Intake of 3 portions of standard dairy products made from milk of cows grazing in lower altitudes, found in local food stores, thus avoiding alpine dairy products during the 6-week intervention period. There are no other restrictions, all dairy products are considered equivalent. Every dairy product intake will be reported into the participants' food log. The participants will be instructed not to change their diet (with the exception of dairy products), lifestyle and physical activity during the study.
Outcomes
Primary Outcomes
Change in fasting blood LDL-cholesterol level
Time Frame: Baseline, Day 15, Day 30 and Day 45
Measure of LDL-cholesterol in mmol/L
Secondary Outcomes
- Change in total cholesterol, triglycerides, HDL-cholesterol and lipoprotein A(Baseline, Day 15, Day 30 and Day 45)