Impact of Alpine Dairy Products on Blood Lipid Levels

A Pilot Study in the Swiss Alps: 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.

Study Overview

• Status: Completed
• Conditions: Elevated Cholesterol
• Intervention / Treatment: Other: Alpine dairy products

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Santa Maria, Switzerland, 7536
    • Center da Sandà Val Müstair

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Alpine dairy products; 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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in fasting blood LDL-cholesterol level	Measure of LDL-cholesterol in mmol/L	Baseline, Day 15, Day 30 and Day 45

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in total cholesterol, triglycerides, HDL-cholesterol and lipoprotein A	Measures in mmol/L	Baseline, Day 15, Day 30 and Day 45

Collaborators and Investigators

• Sponsor: University of Fribourg
• Investigators: Study Director: Pierre-Yves Rodondi, Prof, University of Fribourg

Study record dates

Study Major Dates

• Study Start (Actual): August 25, 2024
• Primary Completion (Actual): November 1, 2024
• Study Completion (Actual): November 15, 2024

Study Registration Dates

• First Submitted: September 26, 2024
• First Submitted That Met QC Criteria: November 15, 2024
• First Posted (Estimated): November 19, 2024

Study Record Updates

• Last Update Posted (Estimated): November 19, 2024
• Last Update Submitted That Met QC Criteria: November 15, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Hypercholesterolemia
• Other Study ID Numbers: 2023-01411

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No