Impact of Alpine Dairy Products on Blood Lipid Levels

NCT06693947 | Completed

• 1 other identifier: 2023-01411
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Elevated Cholesterol

Outcome Measures

Primary Outcomes (1)

• Change in fasting blood LDL-cholesterol level

  Measure of LDL-cholesterol in mmol/L

  Baseline, Day 15, Day 30 and Day 45

Secondary Outcomes (1)

• Change in total cholesterol, triglycerides, HDL-cholesterol and lipoprotein A

  Baseline, Day 15, Day 30 and Day 45

Study Arms (2)

Alpine dairy products

EXPERIMENTAL

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

Non-alpine dairy products

NO INTERVENTION

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

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.

Alpine dairy products

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Fribourg: lead

Study Sites (1)

Center da Sandà Val Müstair

Santa Maria, 7536, Switzerland

Location

MeSH Terms

Conditions

Hypercholesterolemia

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Pierre-Yves Rodondi, Prof

  University of Fribourg

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2024
• First Posted: November 19, 2024
• Study Start: August 25, 2024
• Primary Completion: November 1, 2024
• Study Completion: November 15, 2024
• Last Updated: November 19, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)