DyslipidemiaNCT02835651
Saturated Fatty Acids and HDL Metabolism
A study testing Palmitic acid and Stearic acid in people with Dyslipidemia, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
The purpose of this study is to determine whether palmitic acid (C16:0) and stearic acid (C18:0) have different effects on HDL metabolism during the fasted state. Read more about this study
- Who is it for?
- Ages 45 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Dyslipidemia
- What is being tested?
- Palmitic acid and Stearic acid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteNetherlands
- Study dates
- 14 Apr 2016to 1 Jul 2017
- 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 45 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Apparently healthy men and post-menopausal women (post-menopausal for at least one year) as judged by study physician
- BMI ≥ 18.0 and ≤ 30.0 kg/m2
- Aged between 45 and 70 years
- Willing to comply to study protocol during study
- Having a general practitioner
- Agreeing to be informed about medically relevant personal test-results by a physician
- Informed consent signed
- Accessible veins on arms as determined by examination at screening
Who cannot join
- Having a medical condition which might impact study measurements
- Use of over-the-counter and prescribed medication, which may interfere with study measurements
- Use of oral antibiotics in 40 days or less prior to the start of the study;
- Use of food supplements or plant-sterol/stanol-enriched foods or supplements in the three months prior to the screening and/or during the study;
- Reported alcohol consumption ≥ 10 units/week (female) or ≥ 14 units/week (male);
- Reported intense sporting activities ≥ 10 hours/week;
Show all 15Show fewer
- Reported weight loss or gain of 3 kg or more during a period of 2 months prior to screening
- Regular smokers (at least one cigarette (or equivalent) daily or >7 cigarettes (or equivalent) weekly. Smokers who cannot comfortably restrain from smoking for up to 2 days will also be excluded
- Reported dietary habits: medically prescribed diet, allergy/intolerance to test products that will be provided during the study
- Blood donation in the past 3 months
- Drug abuse
- Reported participation in another nutritional or biomedical trial 3 months prior to screening
- Fasting triacylglycerol concentrations at screening: ≥ 4.5 mmol/L
- Serum lipids: treatment recommended according to the "Multidisciplinary guidelines Cardiovascular risk management"
- Fasting HbA1c ≥ 48 mmol/mol (or 6.5%)
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Maastricht University Medical Center
Maastricht, Limburg, 6200 MD
About this study
Official title: Effects of C16:0 Versus C18:0 on HDL Metabolism and Other Cardiometabolic Risk Markers: A Dietary Intervention Study in Healthy Normal-weight and Overweight Subjects
The purpose of this study is to determine whether palmitic acid (C16:0) and stearic acid (C18:0) have different effects on HDL metabolism during the fasted state.
Read the detailed description
Study design:
Double blind, randomized, cross-over study with two different diets: one diet will be high in palmitic acid (C16:0) and the other diet will be high in stearic acid (C18:0). Subjects will receive both diets for 4 weeks with a wash-out period of 4-6 weeks in between. Contrast in the intakes of palmitic acid and stearic acid is 6% of energy. A postprandial test will be carried out at the end of each dietary period.
Study population:
Accounting for a dropout rate of 20%, 40 healthy men and postmenopausal women, aged between 45 and 70 year, having a BMI (body mass index) between ≥ 18.0 and ≤ 30.0 kg/m2 will be recruited.
- Conditions
- Dyslipidemia
- Being tested
- Palmitic acid, Stearic acid
- Keywords
- Palmitic acid, Stearic acid, HDL-metabolism, Human intervention study
- Medical subject headings
- Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Palmitic acidDietary supplement
Experimental products are enriched with C16:0
Stearic acidDietary supplement
Experimental products are enriched with C18:0
| Study group | Role | What they receive |
|---|---|---|
| Palmitic acid | Experimental | Diet rich in palmitic acid Receives: Dietary Supplement: Palmitic acid |
| Stearic acid | Experimental | Diet rich in stearic acid Receives: Dietary Supplement: Stearic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cholesterol efflux capacity after dietary period high in palmitic acid compared to dietary period high in stearic acid
J774 Macrophages will be used to measure ex vivo cholesterol efflux capacity of HDL particles after a diet enriched with C16:0 or C18:0. Change in ex vivo cholesterol efflux capacity between the diets will be assessed using a linear mixed model with subject as random factor and day 0 as co-variant.
Measured: Cholesterol efflux is measured during fasted state at day 0, day 25 and day 28 of each intervention period.
Secondary outcomes (4)
Change in fasted lipid metabolism markers between dietary period high in palmitic acid and dietary period high in stearic acid
Markers include fasting LDL-C [mmol/L], HDL-C [mmol/L], total cholesterol [mmol/L], non-HDL cholesterol [mmol/L] and triacylglycerol [mmol/L] concentrations. Change between diets will be assessed using a linear mixed model with subject as random factor and day 0 as co-variant.
Measured: Markers for lipid metabolism will be measured during fasted state at day 0, day 14, day 25 and day 28 of each intervention period
Change in fasted lipid ratios between dietary period high in palmitic acid and dietary period high in stearic acid
Markers include fasting total cholesterol to HDL-C ratio and LDL-C to HDL-C ratio. Change between diets will be assessed using a linear mixed model with subject as random factor and day 0 as co-variant.
Measured: Markers for lipid metabolism will be measured during fasted state at day 0, day 14, day 25 and day 28 of each intervention period
Change in fasted apolipoproteins between dietary period high in palmitic acid and dietary period high in stearic acid
Apolipoproteins include fasting ApoA1 [μg/mL] and ApoB100 [μg/mL]. Change between diets will be assessed using a linear mixed model with subject as random factor and day 0 as co-variant.
Measured: Apolipoproteins will be measured during fasted state at day 0, day 14, day 25 and day 28 of each intervention period
Change in postprandial triacylglycerol levels between dietary period high in palmitic acid and dietary period high in stearic acid
Change between diets will be assessed using a linear mixed model with subject as random factor and day 0 as co-variant.
Measured: Triacylglycerol [mmol/L] is measured during postprandial state at day 28 (0 to 480 minutes after meal intake) of each intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2016 (estimated)
- Study start14 Apr 2016
- Primary completion1 Jul 2017
- Study completion1 Jul 2017
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 DyslipidemiaStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Unilever R&D
- Responsible party
- Sponsor
- Investigators
- Ronald P Mensink, PhD, Principal investigator, Maastricht University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02835651
- Sponsor's protocol ID
- METC 15-3-052
- Status last verified
- Mar 2017
- First submitted
- 18 May 2016
- Last updated
- 22 Aug 2017
- Results posted
- No
Publications
van Rooijen MA, Plat J, Zock PL, Blom WAM, Mensink RP. Effects of two consecutive mixed meals high in palmitic acid or stearic acid on 8-h postprandial lipemia and glycemia in healthy-weight and overweight men and postmenopausal women: a randomized controlled trial. Eur J Nutr. 2021 Oct;60(7):3659-3667. doi: 10.1007/s00394-021-02530-2. Epub 2021 Mar 17.
PubMed 33733339van Rooijen MA, Plat J, Blom WAM, Zock PL, Mensink RP. Dietary stearic acid and palmitic acid do not differently affect ABCA1-mediated cholesterol efflux capacity in healthy men and postmenopausal women: A randomized controlled trial. Clin Nutr. 2021 Mar;40(3):804-811. doi: 10.1016/j.clnu.2020.08.016. Epub 2020 Aug 27.
PubMed 32900520
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of C16:0 Versus C18:0 on HDL Metabolism and Other Cardiometabolic Risk Markers: A Dietary Intervention Study in Healthy Normal-weight and Overweight Subjects
- ClinicalTrials.gov ID
- NCT02835651
- Acronym / sponsor ID
- METC 15-3-052
- Conditions
- Dyslipidemia
- Keywords
- Palmitic acid, Stearic acid, HDL-metabolism, Human intervention study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- Unilever R&D
- Study start
- 14 Apr 2016 (actual)
- Primary completion
- 1 Jul 2017 (actual)
- Study completion
- 1 Jul 2017 (actual)
- First posted
- 18 Jul 2016 (estimated)
- 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 purpose of this study is to determine whether palmitic acid (C16:0) and stearic acid (C18:0) have different effects on HDL metabolism during the fasted state.
Detailed description
Study design:
Double blind, randomized, cross-over study with two different diets: one diet will be high in palmitic acid (C16:0) and the other diet will be high in stearic acid (C18:0). Subjects will receive both diets for 4 weeks with a wash-out period of 4-6 weeks in between. Contrast in the intakes of palmitic acid and stearic acid is 6% of energy. A postprandial test will be carried out at the end of each dietary period.
Study population:
Accounting for a dropout rate of 20%, 40 healthy men and postmenopausal women, aged between 45 and 70 year, having a BMI (body mass index) between ≥ 18.0 and ≤ 30.0 kg/m2 will be recruited.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Palmitic acid | Experimental | Dietary Supplement: Palmitic acidDiet rich in palmitic acid |
| Stearic acid | Experimental | Dietary Supplement: Stearic acidDiet rich in stearic acid |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Apparently healthy men and post-menopausal women (post-menopausal for at least one year) as judged by study physician
- BMI ≥ 18.0 and ≤ 30.0 kg/m2
- Aged between 45 and 70 years
- Willing to comply to study protocol during study
- Having a general practitioner
Key exclusion criteria (15 listed)
- Having a medical condition which might impact study measurements
- Use of over-the-counter and prescribed medication, which may interfere with study measurements
- Use of oral antibiotics in 40 days or less prior to the start of the study;
- Use of food supplements or plant-sterol/stanol-enriched foods or supplements in the three months prior to the screening and/or during the study;
- Reported alcohol consumption ≥ 10 units/week (female) or ≥ 14 units/week (male);
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 |
|---|---|---|
| Palmitic acidExperimental products are enriched with C16:0 | Dietary supplement | Palmitic acid |
| Stearic acidExperimental products are enriched with C18:0 | Dietary supplement | Stearic acid |
Primary outcome
Cholesterol efflux capacity after dietary period high in palmitic acid compared to dietary period high in stearic acid
Time frame: Cholesterol efflux is measured during fasted state at day 0, day 25 and day 28 of each intervention period.
J774 Macrophages will be used to measure ex vivo cholesterol efflux capacity of HDL particles after a diet enriched with C16:0 or C18:0. Change in ex vivo cholesterol efflux capacity between the diets will be assessed using a linear mixed model with subject as random factor and day 0 as co-variant.
4 secondary outcomes
Change in fasted lipid metabolism markers between dietary period high in palmitic acid and dietary period high in stearic acid
Time frame: Markers for lipid metabolism will be measured during fasted state at day 0, day 14, day 25 and day 28 of each intervention period
Change in fasted lipid ratios between dietary period high in palmitic acid and dietary period high in stearic acid
Time frame: Markers for lipid metabolism will be measured during fasted state at day 0, day 14, day 25 and day 28 of each intervention period
Change in fasted apolipoproteins between dietary period high in palmitic acid and dietary period high in stearic acid
Time frame: Apolipoproteins will be measured during fasted state at day 0, day 14, day 25 and day 28 of each intervention period
Change in postprandial triacylglycerol levels between dietary period high in palmitic acid and dietary period high in stearic acid
Time frame: Triacylglycerol [mmol/L] is measured during postprandial state at day 28 (0 to 480 minutes after meal intake) of each intervention period
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 22 Aug 2017.
- Derived from this study: PubMed 33733339van Rooijen MA, Plat J, Zock PL, Blom WAM, Mensink RP. Effects of two consecutive mixed meals high in palmitic acid or stearic acid on 8-h postprandial lipemia and glycemia in healthy-weight and overweight men and postmenopausal women: a randomized controlled trial. Eur J Nutr. 2021 Oct;60(7):3659-3667. doi: 10.1007/s00394-021-02530-2. Epub 2021 Mar 17.
- Derived from this study: PubMed 32900520van Rooijen MA, Plat J, Blom WAM, Zock PL, Mensink RP. Dietary stearic acid and palmitic acid do not differently affect ABCA1-mediated cholesterol efflux capacity in healthy men and postmenopausal women: A randomized controlled trial. Clin Nutr. 2021 Mar;40(3):804-811. doi: 10.1016/j.clnu.2020.08.016. Epub 2020 Aug 27.
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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.
Ronald P Mensink, PhD principal investigator
Maastricht University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Palmitic acid and Stearic acid in people with Dyslipidemia, run by Maastricht University Medical Center at 1 site in Netherlands.
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 8 inclusion and 15 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 22 Aug 2017. 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 Netherlands. 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?
Cholesterol efflux capacity after dietary period high in palmitic acid compared to dietary period high in stearic acid (time frame: Cholesterol efflux is measured during fasted state at day 0, day 25 and day 28 of each intervention period.). 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 NCT02835651, 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 22 Aug 2017.