Elevated CholesterolNCT06693947
Impact of Alpine Dairy Products on Blood Lipid Levels
A study testing Alpine dairy products in people with Elevated Cholesterol, run by University of Fribourg at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Elevated Cholesterol
- What is being tested?
- Alpine dairy products
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteSwitzerland
- Study dates
- 25 Aug 2024to 15 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Elevated Cholesterol
- Being tested
- Alpine dairy products
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alpine dairy productsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in fasting blood LDL-cholesterol level
Measure of LDL-cholesterol in mmol/L
Measured: 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
Measured: Baseline, Day 15, Day 30 and Day 45
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2024
- Study start25 Aug 2024
- Primary completion1 Nov 2024
- Study completion15 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elevated CholesterolStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Fribourg
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre-Yves Rodondi, Prof, Study director, University of Fribourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06693947
- Sponsor's protocol ID
- 2023-01411
- Other IDs
- 2023
- Status last verified
- Nov 2024
- First submitted
- 26 Sep 2024
- Last updated
- 19 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study in the Swiss Alps: Impact of Alpine Dairy Products on Blood Lipid Levels
- ClinicalTrials.gov ID
- NCT06693947
- Acronym / sponsor ID
- 2023-01411
- Conditions
- Elevated Cholesterol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University of FribourgUniversity, hospital or other
- Study start
- 25 Aug 2024 (actual)
- Primary completion
- 1 Nov 2024 (actual)
- Study completion
- 15 Nov 2024 (actual)
- First posted
- 19 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alpine dairy products | Experimental | Other: Alpine dairy productsIntake 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alpine dairy productsThe 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. | Other | Alpine dairy products |
Primary outcome
Change in fasting blood LDL-cholesterol level
Time frame: Baseline, Day 15, Day 30 and Day 45
Measure of LDL-cholesterol in mmol/L
1 secondary outcome
Change in total cholesterol, triglycerides, HDL-cholesterol and lipoprotein A
Time frame: Baseline, Day 15, Day 30 and Day 45
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2024.
- Individual participant dataSharing planned: No
Related trials for Elevated Cholesterol
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A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
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Early Detection of Familial Hypercholesterolaemia in Pre-school Children ( CzeCH-IT)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre-Yves Rodondi, Prof study director
University of Fribourg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alpine dairy products in people with Elevated Cholesterol, run by University of Fribourg at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in fasting blood LDL-cholesterol level (time frame: Baseline, Day 15, Day 30 and Day 45). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2024.