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| Name | Class |
|---|---|
| Unilever R&D | INDUSTRY |
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Palmitic acid | Experimental | Diet rich in palmitic acid |
|
| Stearic acid | Experimental | Diet rich in stearic acid |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Palmitic acid | Dietary Supplement | Experimental products are enriched with C16:0 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Cholesterol efflux is measured during fasted state at day 0, day 25 and day 28 of each intervention period. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ronald P Mensink, PhD | Maastricht University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maastricht University Medical Center | Maastricht | Limburg | 6200 MD | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33733339 | Derived | 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. | |
| 32900520 |
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| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D019308 | Palmitic Acid |
| C031183 | stearic acid |
| ID | Term |
|---|---|
| D010169 | Palmitic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
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| Stearic acid |
| Dietary Supplement |
Experimental products are enriched with C18:0 |
|
| 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. | 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. | 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. | Triacylglycerol [mmol/L] is measured during postprandial state at day 28 (0 to 480 minutes after meal intake) of each intervention period |
| van 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. |