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NCT Number: NCT06693947

Impact of Alpine Dairy Products on Blood Lipid Levels

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.

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Key information

Conditions

Elevated Cholesterol Dyslipidemias Hypercholesterolemia Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center da Sandà Val Müstair

Santa Maria, 7536, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Alpine dairy products

Other

The intervention group will be instructed to eat three portions of alpine dairy products daily. The proposed three portions represent an estimated mean consummation in the study population, taking into consideration the national statistics.

Primary outcomes

  1. 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

  1. Change in total cholesterol, triglycerides, HDL-cholesterol and lipoprotein A

    Time frame: Baseline, Day 15, Day 30 and Day 45

    Measures in mmol/L

Sponsors and collaborators

Lead sponsor

University of Fribourg

Other

Registry information

Official study title

A Pilot Study in the Swiss Alps: Impact of Alpine Dairy Products on Blood Lipid Levels

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Nov 19, 2024
Registry last updated
Nov 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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