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CompletedNCT06693947Updated Nov 19, 2024

Impact of Alpine Dairy Products on Blood Lipid Levels

An interventional study of Alpine dairy products in Elevated Cholesterol, sponsored by University of Fribourg. Completed at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-19.

Sponsored by University of Fribourg · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
29
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Elevated Cholesterol
03

In context

Hypercholesterolemia

1,238 studies on the registry are indexed under Hypercholesterolemia; 109 are open to participants now.

This study's enrollment of 29 is below the median of 99 across 991 interventional studies indexed under Hypercholesterolemia.

Browse Hypercholesterolemia studies →

Lead sponsor

University of Fribourg is the lead sponsor of 15 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
29 participants (actual)

Study arms

  • 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

  • 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.

Interventions

  • OtherAlpine 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.

06

What researchers measure

Primary outcomes

  1. Change in fasting blood LDL-cholesterol level

    Measure of LDL-cholesterol in mmol/L

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

Secondary outcomes

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

    Measures in mmol/L

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

07

Study locations

1 site
  • Center da Sandà Val Müstair
    Santa Maria, 7536, Switzerland
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06693947
Lead sponsor
University of Fribourg
Responsible party
Sponsor
First posted
Nov 19, 2024
Start date
Aug 25, 2024
Primary completion
Nov 1, 2024
Completion
Nov 15, 2024
Last update
Nov 19, 2024

Study contacts

Pierre-Yves Rodondi, Prof
study director · University of Fribourg

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.

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