AtherosclerosisNCT03052582
Whole Milk Compared With Skimmed Milk and Effect on Lipids
A study testing Milk type in people with Atherosclerosis, run by University of Copenhagen at 1 site in Denmark.
Trial summary
The aim of the project is to investigate the effects in humans of a daily intake of whole milk compared to skimmed milk primarily and secondarily respectively on: Blood lipids: total-, LDL-, and HDL-cholesterol and triglycerides Risk markers of diabetes type 2: plasma glucose and insulin Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Atherosclerosis
- What is being tested?
- Milk type
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2015to Jul 2016
- 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 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All subjects must give their informed consent in writing, after having received oral and written information about the study
- Age: 20-70 y
- BMI: 18.5 - 30 kg/m2
- Healthy men and women (with no known diseases)
Who cannot join
- Current or previous cardiovascular disease, high blood pressure or cholesterol
- Diabetes Mellitus or other severe chronic disease, including severe allergies
- Lactose intolerant or milk allergy
- Use of dietary supplements two month prior to and during the intervention Blood donations 1 month prior to and during the intervention
- Known or suspected abuse of alcohol, drugs or medication
- Pregnant or are planning pregnancy during the study period
Show all 9Show fewer
- Extreme physical activity level (more than 10 hours tough physical activity pr. week)
- Participation in other research studies
- Inability, physically or mentally, to comply with the procedures required by the study protocol, as evaluated by the study staff
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Nutrition, Exercise and Sports, University of Copenhagen
Copenhagen, 1958
About this study
Official title: Whole Milk Compared With Skimmed Milk and Effect on Lipids - A Randomized, Controlled Cross-over Study
The aim of the project is to investigate the effects in humans of a daily intake of whole milk compared to skimmed milk primarily and secondarily respectively on:
- Blood lipids: total-, LDL-, and HDL-cholesterol and triglycerides
- Risk markers of diabetes type 2: plasma glucose and insulin
Read the detailed description
This study will be a randomized controlled 2 x 3 weeks crossover intervention study with no wash-out period, as the lipids in the blood are known to adjust after 2 weeks. The effects of a diet containing 0.5 L of whole milk (17.5 g of milk fat/day) will be compared with a diet containing 0.5 L of skimmed milk (1.5 g of milk fat/day). Blinding is not possible since the appearance of the test foods cannot be concealed. The study subjects will receive the two test foods in random order, decided by draw of lots. Blood samples will be drawn on the first day of the period and in the end of the period for each 3 week-periods.
- Conditions
- Atherosclerosis
- Being tested
- Milk type
- Medical subject headings
- Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Milk typeOther
| Study group | Role | What they receive |
|---|---|---|
| Team 1: skimmed/whole | Active comparator | Milktype: 3 weeks with skimmed milk followed by 3 weeks with whole milk Receives: Other: Milk type |
| Team 2: whole/skimmed | Active comparator | Milktype: 3 weeks with whole milk followed by 3 weeks with skimmed milk Receives: Other: Milk type |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting blood lipids
total, LDL and HDL cholesterol and TAG
Measured: 3 weeks
Secondary outcomes (2)
fasting plasma glucose
Measured: 3 weeks
fasting serum insulin
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2017
- Study startOct 2015
- Primary completionDec 2015
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AtherosclerosisStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe sponsor's other registered studies.
- 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
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arne Astrup, University of Copenhagen
- Investigators
- Tine Tholstrup, Ass Prof., Principal investigator, Department of Nutrition, Exercise and Sports, Univeristy of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03052582
- Sponsor's protocol ID
- M227
- Status last verified
- Mar 2018
- First submitted
- 8 Feb 2017
- Last updated
- 2 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Hansen NM, Berg P, Rix M, Pareek M, Leipziger J, Kamper AL, Astrup A, Vaarby Sorensen M, Salomo L. The New Nordic Renal Diet Induces a Pronounced Reduction of Urine Acid Excretion and Uremic Toxins in Chronic Kidney Disease Patients (Stage 3 and 4). J Ren Nutr. 2023 May;33(3):412-419. doi: 10.1053/j.jrn.2022.09.010. Epub 2022 Oct 3.
PubMed 36195272Engel S, Elhauge M, Tholstrup T. Effect of whole milk compared with skimmed milk on fasting blood lipids in healthy adults: a 3-week randomized crossover study. Eur J Clin Nutr. 2018 Feb;72(2):249-254. doi: 10.1038/s41430-017-0042-5. Epub 2017 Dec 11.
PubMed 29229955
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Whole Milk Compared With Skimmed Milk and Effect on Lipids - A Randomized, Controlled Cross-over Study
- ClinicalTrials.gov ID
- NCT03052582
- Acronym / sponsor ID
- M227
- Conditions
- Atherosclerosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Study start
- Oct 2015 (actual)
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 14 Feb 2017 (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.
The aim of the project is to investigate the effects in humans of a daily intake of whole milk compared to skimmed milk primarily and secondarily respectively on:
- Blood lipids: total-, LDL-, and HDL-cholesterol and triglycerides
- Risk markers of diabetes type 2: plasma glucose and insulin
Detailed description
This study will be a randomized controlled 2 x 3 weeks crossover intervention study with no wash-out period, as the lipids in the blood are known to adjust after 2 weeks. The effects of a diet containing 0.5 L of whole milk (17.5 g of milk fat/day) will be compared with a diet containing 0.5 L of skimmed milk (1.5 g of milk fat/day). Blinding is not possible since the appearance of the test foods cannot be concealed. The study subjects will receive the two test foods in random order, decided by draw of lots. Blood samples will be drawn on the first day of the period and in the end of the period for each 3 week-periods.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Team 1: skimmed/whole | Active comparator | Other: Milk typeMilktype: 3 weeks with skimmed milk followed by 3 weeks with whole milk |
| Team 2: whole/skimmed | Active comparator | Other: Milk typeMilktype: 3 weeks with whole milk followed by 3 weeks with skimmed milk |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- All subjects must give their informed consent in writing, after having received oral and written information about the study
Key exclusion criteria (9 listed)
- Current or previous cardiovascular disease, high blood pressure or cholesterol
- Diabetes Mellitus or other severe chronic disease, including severe allergies
- Lactose intolerant or milk allergy
- Use of dietary supplements two month prior to and during the intervention Blood donations 1 month prior to and during the intervention
- Known or suspected abuse of alcohol, drugs or medication
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 |
|---|---|---|
| Milk type | Other | Team 1: skimmed/whole, Team 2: whole/skimmed |
Primary outcome
Fasting blood lipids
Time frame: 3 weeks
total, LDL and HDL cholesterol and TAG
2 secondary outcomes
fasting plasma glucose
Time frame: 3 weeks
fasting serum insulin
Time frame: 3 weeks
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 2 Apr 2018.
- Derived from this study: PubMed 36195272Hansen NM, Berg P, Rix M, Pareek M, Leipziger J, Kamper AL, Astrup A, Vaarby Sorensen M, Salomo L. The New Nordic Renal Diet Induces a Pronounced Reduction of Urine Acid Excretion and Uremic Toxins in Chronic Kidney Disease Patients (Stage 3 and 4). J Ren Nutr. 2023 May;33(3):412-419. doi: 10.1053/j.jrn.2022.09.010. Epub 2022 Oct 3.
- Derived from this study: PubMed 29229955Engel S, Elhauge M, Tholstrup T. Effect of whole milk compared with skimmed milk on fasting blood lipids in healthy adults: a 3-week randomized crossover study. Eur J Clin Nutr. 2018 Feb;72(2):249-254. doi: 10.1038/s41430-017-0042-5. Epub 2017 Dec 11.
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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.
Tine Tholstrup, Ass Prof. principal investigator
Department of Nutrition, Exercise and Sports, Univeristy of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Milk type in people with Atherosclerosis, run by University of Copenhagen at 1 site in Denmark.
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 4 inclusion and 9 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 2 Apr 2018. 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 Denmark. 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?
Fasting blood lipids (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03052582, which also lists 2 linked publications.
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 2 Apr 2018.