Cardiovascular DiseasesNCT06481020
Plant Sterols on Cardiovascular Markers, Microbiota and Sterol Metabolism (Cardiofoodsterol)
A study testing Plant sterols 2g/day in people with Cardiovascular Diseases and Hypercholesterolemia, run by University of Valencia at 1 site in Spain.
Trial summary
Potential cholesterol-lowering effect of a regular intake of a plant sterol (PS)-containing food supplement, in overweight/obese type 1 or 2, normoglycemic/pre-diabetic, with LDL-cholesterol values > 115 mg/dl and not pharmacologically treated participants treated with the PS-containing food supplement or placebo… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cardiovascular Diseases, Hypercholesterolemia, Prediabetic State
- What is being tested?
- Plant sterols 2g/day
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteSpain
- Study dates
- 21 May 2024to Feb 2025
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BMI: 27-29.9 or 30-39.9
- Plasmatic glucose: < 100mg/dl or 100-125mg/dl
- Glycosylated hemoglobin: < 5.7 or 5.7-6.4
- LDL cholesterol > 115mg/dL
- Serum levels of biochemical and hematological parameters and fat-soluble vitamins within reference ranges.
Who cannot join
- Subjects on cholesterol-lowering pharmacological treatment
- Smokers
- Alcohol consumption above 30 g/day
- Pregnant or lactating women
- Any infection, serious illness or co-morbidity that may affect the bioavailability of PS (e.g., malabsorption, celiac disease, allergies or food intolerances)
- Diseases of the gastrointestinal tract
Show all 9Show fewer
- Antibiotic, hormonal or anabolic treatment
- Participants consuming foods enriched with PS or food supplements that contain PS
- Participants who follow specialist weight loss diets, vegans or vegetarians
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario y Politécnico La Fe de Valencia
Valencia, 46026
Juan Francisco Merino Torres
About this study
Official title: Effect of Plant Sterols on Inflammatory, Endothelial Function and Oxidative Stress Markers, Microbiota and Sterol Metabolism in a Cardiovascular Risk Population
Potential cholesterol-lowering effect of a regular intake of a plant sterol (PS)-containing food supplement, in overweight/obese type 1 or 2, normoglycemic/pre-diabetic, with LDL-cholesterol values > 115 mg/dl and not pharmacologically treated participants treated with the PS-containing food supplement or placebo supplement.
Read the detailed description
Cardiovascular disease (CVD) is the leading cause of death worldwide, with hypercholesterolemia being one of the main risk factors for CVD. The deposition and oxidation of LDL-cholesterol particles triggers a series of molecular events favoring chronic low-grade inflammation, endothelial dysfunction and oxidative stress. This situation promotes atherogenesis thus increasing cardiovascular risk. Obesity favors the secretion of pro-inflammatory mediators and promotes the recruitment of macrophages to adipose tissue, insulin resistance, hyperglycemia and hyperlipidemia, thus increasing the risk of CVD. In addition, obesity has been associated with gut dysbiosis, which in turn is associated with atherosclerosis in some studies. Beneficial effects of PS on LDL-cholesterol and inflammatory, endothelial dysfunction and oxidative stress markers have been reported by several clinical trials. A meta-analysis suggests a lowering effect of PS on body mass index (BMI) in participants with BMI>25. Furthermore, the consumption of PS has been beneficially associated in in vitro studies with changes in intestinal microbial profile, sterol metabolism and short chain fatty acids (SCFA) production. Therefore, the hypothesis is if the consumption of PS as a food supplementation could reduce cardiovascular risk. The present study aims to evaluate the LDL-cholesterol serum levels after regular intake of a food supplement containing PS (2 g/day) in overweight/obese type 1 or 2 patients, normoglycemic /pre-diabetic and with LDL-cholesterol values > 115 mg/dl not pharmacologically treated. This is a crossover study with 21 participants (intake of a food supplement containing PS) and 21 participants (intake of excipient-based placebo), with a first intervention period of 8 weeks. After a 6-week washout period, the treatments are switched, with a second intervention period of 8 weeks. In addition, to the LDL-cholesterol lowering assessment, other biochemical, hematological, inflammatory, endothelial dysfunction and oxidative stress parameters are assessed in serum samples. Moreover, sterol and metabolite profiling in serum and feces, microbiota modulation, anthropometric measurements and body composition, bioimpedance, dietary intake and physical activity questionnaire are evaluated. All parameters are evaluated at the beginning (weeks 0 and 14) and at the end of each intervention period (weeks 8 and 22).
- Being tested
- Plant sterols 2g/day, Placebo
- Keywords
- Cholesterol LDL, Plant Sterols, Inflammation, Oxidative Stress, Microbiota, Sterol Metabolites, Endothelial function, Bioimpedance, Dietary Intake, Physical Activity
- Medical subject headings
- Cardiovascular Diseases, Hypercholesterolemia, Prediabetic State, Overweight, Obesity, Inflammation, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plant sterols 2g/dayDietary supplement
PS-containing dietary supplement Sachet containing a powdered microencapsulated free plant sterols (2 g ingredient/day) during 8 weeks
PlaceboDietary supplement
Sachet containing the powdered excipients of the dietary supplement during 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Dietary Supplement | Experimental | PS-containing dietary supplement Sachet containing a powdered microencapsulated free plant sterols (2 g ingredient/day) Receives: Dietary Supplement: Plant sterols 2g/day |
| Placebo | Placebo comparator | Sachet containing the powdered excipients of the dietary supplement Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in plasmatic LDL-c
LDL-c, calculated by the Friedewald's formula, with repeated measures (at the beginning and at the end of each period the intervention)
Measured: 0, 8, 14 and 22 weeks
Secondary outcomes (38)
Changes in plasmatic total cholesterol
Total cholesterol, assessed by enzymatic-colorimetric methods, with repeated measures (at the beginning and at the end of each period the intervention)
Measured: 0, 8, 14 and 22 weeks
Changes in plasmatic HDL-c
HDL-c, assessed by enzymatic-colorimetric methods, with repeated measures (at the beginning and at the end of each period the intervention)
Measured: 0, 8, 14 and 22 weeks
Changes in plasmatic non-HDL cholesterol
Non-HDL cholesterol, calculated by subtracting HDL-c from total cholesterol, with repeated measures (at the beginning and at the end of each period the intervention)
Measured: 0, 8, 14 and 22 weeks
Changes in plasmatic triglycerides
Triglycerides, assessed by enzymatic-colorimetric methods, with repeated measures (at the beginning and at the end of each period the intervention)
Measured: 0, 8, 14 and 22 weeks
Changes in plasmatic Apo A
Apo A, assessed by enzymatic-colorimetric methods, with repeated measures (at the beginning and at the end of each period the intervention)
Measured: 0, 8, 14 and 22 weeks
Changes in plasmatic Apo B
Apo B, assessed by enzymatic-colorimetric methods, with repeated measures (at the beginning and at the end of each period the intervention
Measured: 0, 8, 14 and 22 weeks
Changes in plasmatic fibrinogen
Fibrinogen, assessed by Clauss coagulometric method, with repeated measures (at the beginning and at the end of each period the intervention)
Measured: 0, 8, 14 and 22 weeks
Changes in plasmatic High-sensitivity C-reactive protein (hsCRP)
hs CRP, assessed by enzymatic-colorimetric methods, with repeated measures (at the beginning and at the end of each period the intervention)
Measured: 0, 8, 14 and 22 weeks
Changes in plasmatic glucose
Glucose, assessed by enzymatic-colorimetric methods, with repeated measures (at the beginning and at the end of each period the intervention)
Measured: 0, 8, 14 and 22 weeks
Changes in plasmatic insulin
Insulin, assessed by enzymatic-colorimetric methods, with repeated measures (at the beginning and at the end of each period the intervention
Measured: 0, 8, 14 and 22 weeks
Changes in plasmatic Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)
HOMA-IR, calculated by mathematical formula from the fasting insulin and fasting glucose levels, with repeated measures (at the beginning and at the end of each period the intervention)
Measured: 0, 8, 14 and 22 weeks
Changes in serum levels of the sterols and metabolites profile
Profile sterols and metabolites, assessed by gas chromatography coupled with flame ionization detector (GC-FID), with repeated measures (at the beginning and at the end of each period the intervention)
Measured: 0, 8, 14 and 22 weeks
Changes in feces levels of the sterols and metabolites profile
Profile sterols and metabolites, assessed by gas chromatography coupled with flame ionization detector (GC-FID), with repeated measures (at the beginning and the end of each period the intervention)
Measured: 0, 8, 14 and 22 weeks
Changes in serum interleukin 10 (IL-10)
IL-10, assessed by immunochemical techniques, with repeated measures (at the beginning and the end of each period the intervention)
Measured: 0, 8, 14 and 22 weeks
Changes in serum interleukin 12p70 (IL-12p70)
IL-12p70, assessed by immunochemical techniques, with repeated measures (at the beginning and the end of each period the intervention)
Measured: 0, 8, 14 and 22 weeks
Changes in serum interleukin 1β (IL-1β)
IL-1β, assessed by immunochemical techniques, with repeated measures (at the beginning and the end of each period the intervention)
Measured: 0, 8, 14 and 22 weeks
Changes in serum interleukin 6 (IL-6)
IL-6, assessed by immunochemical techniques, with repeated measures (at the beginning and the end of each period the intervention)
Measured: 0, 8, 14 and 22 weeks
Changes in serum interleukin 8 (IL-8)
IL-8, assessed by immunochemical techniques, with repeated measures (at the beginning and the end of each period the intervention)
Measured: 0, 8, 14 and 22 weeks
Changes in serum tumor necrosis factor alpha (TNFα)
TNFα, assessed by immunochemical techniques, with repeated measures (at the beginning and the end of each period the intervention)
Measured: 0, 8, 14 and 22 weeks
Changes in serum vascular cell adhesion molecule-1 (VCAM-1)
VCAM-1, assessed by immunochemical techniques, with repeated measures (at the beginning and the end of each period the intervention)
Measured: 0, 8, 14 and 22 weeks
Changes in serum E-Selectin
E- Selectin, assessed by immunochemical techniques, with repeated measures (at the beginning and the end of each period the intervention)
Measured: 0, 8, 14 and 22 weeks
Changes in serum endothelin (ET-1)
ET-1, assessed by immunochemical techniques, with repeated measures (at the beginning and the end of each period the intervention
Measured: 0, 8, 14 and 22 weeks
Changes in serum plasminogen activator inhibitor-1(PAI-1)
PAI-1, assessed by immunochemical techniques, with repeated measures (at the beginning and the end of each period the intervention)
Measured: 0, 8, 14 and 22 weeks
Changes in plasmatic LDL-cholesterol oxidation
LDL-cholesterol oxidation, assessed by enzyme kits, with repeated measures (at the beginning and the end of each period the intervention)
Measured: 0, 8, 14 and 22 weeks
Changes in plasmatic 8-isoprostane
8-isoprostane, assessed by enzyme kits, with repeated measures (at the beginning and the end of each period the intervention)
Measured: 0, 8, 14 and 22 weeks
Changes in plasmatic malondialdehyde (MDA)
MDA, assessed by ultra-performance liquid chromatography-MS (UPLC-MS), with repeated measures (at the beginning and the end of each period the intervention
Measured: 0, 8, 14 and 22 weeks
Changes in reduced glutathiones (GSH)
GSH, assessed by ultra-performance liquid chromatography-MS (UPLC-MS), with repeated measures (at the beginning and the end of each period the intervention)
Measured: 0, 8, 14 and 22 weeks
Changes in oxidized glutathione (GSSG)
GSSG, assessed by ultra-performance liquid chromatography-MS (UPLC-MS), with repeated measures (at the beginning and the end of each period the intervention)
Measured: 0, 8, 14 and 22 weeks
Changes in the composition of microbiota in feces
Composition of microbiota, assessed by genetic sequencing and subsequent biostatistical analysis, with repeated measures (at the beginning and the end of each period the intervention)
Measured: 0, 8, 14 and 22 weeks
Changes in feces of short-chain fatty acids (SCFAs)
SCFAs, assessed by high-performance liquid chromatography with an ultraviolet detector (HPCL-UV), with repeated measures (at the beginning and the end of each period the intervention)
Measured: 0, 8, 14 and 22 weeks
Changes in plasmatic levels of cholesterol oxidation products (COPs)
COPs, assessed by gas chromatography-mass spectrometry, with repeated measures (at the beginning and the end of each period the intervention)
Measured: 0, 8, 14 and 22 weeks
Changes in body weight (WT)
WT, assessed by standard balance scale, with repeated measures (at the beginning and the end of each period the intervention)
Measured: 0, 8, 14 and 22 weeks
Changes in body height (HT)
HT, assessed by tape measure, with repeated measures (at the beginning and the end of each period the intervention)
Measured: 0, 8, 14 and 22 weeks
Changes in body circumferences
Circumferences, assessed by tape measure, with repeated measures (at the beginning and the end of each period the intervention)
Measured: 0, 8, 14 and 22 weeks
Changes in Bioelectrical impedance analysis (BIA)
BIA, assessed by bio-impedance meter, with repeated measures (at the beginning and the end of each period the intervention)
Measured: 0, 8, 14 and 22 weeks
Assessment of dietary intake
Food frequency survey Questionnaire (FFQ) is used, consisting in 136 questions divided into the different food groups (dairy products; eggs, meat and fish; vegetables; fruit; pulses and cereals; oils and fats; bakery and confectionery; miscellaneous; drinks) indicating the average frequency of consumption during the past year, which can be scored as never or almost never, per month (1-3), per week (1, 2-4,5-6), per day (1, 2-3, 4-6, 6+), with repeated of questionnaire (at the beginning and the end of each period the intervention)
Measured: 0, 8, 14 and 22 weeks
Evaluation of the physical activity to measure quality of life
International physical activity questionnaire-short form (IPAC-SF) is used, consisting in 7 questions. Intensity, frequency and duration of the exercise are evaluated through metabolic equivalent of task (METs). This allows to differentiate 3 levels of physical activity:
Low: Not enough activity to achieve the next level
Moderate: 3 or more days of vigorous physical activity for at least 20 minutes per day, 5 or more days of moderate physical activity and/or walking at least 30 minutes per day, or 5 or more days of any combination of walking, moderate or vigorous physical activity achieving at least a total of 600 METs.
High: Vigorous physical activity at least 3 days per week achieving a total of a least 1500 METs, or 7 days of any combination of walking, with moderate and/or vigorous physical activity, achieving a total of a least 3000 METs.
With repeated of questionnaire (at the beginning and the end of each period the intervention)
Measured: 0, 8, 14 and 22 weeks
Evaluation of the Mediterranean diet adherence to measure quality of life
Mediterranean diet adherence screener (MEDAS) is used, consisting in 14 questions (each one 0 or 1 point, final score between 0 and 14). Results are ranged between 0-7 points (low adherence), 7-10 (moderate adherence), and 10-14 (high adherence) With repeated of questionnaire (at the beginning and the end of each period the intervention)
Measured: 0, 8, 14 and 22 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2024
- Study start21 May 2024
- Primary completionDec 2024 (estimated)
- Study completionFeb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitario La Fe, University of Bologna
- Responsible party
- Principal investigator, Guadalupe García Llatas, University of Valencia
- Investigators
- Guadalupe Garcia Llatas, Professor, Principal investigator, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06481020
- Sponsor's protocol ID
- BIONUTEST_2024-0358-1
- Other IDs
- PID2019-104167RB-I00
- Status last verified
- Jun 2024
- First submitted
- 12 Jun 2024
- Last updated
- 1 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Blanco-Morales V, Garcia-Llatas G, Yebra MJ, Sentandreu V, Lagarda MJ, Alegria A. Impact of a Plant Sterol- and Galactooligosaccharide-Enriched Beverage on Colonic Metabolism and Gut Microbiota Composition Using an In Vitro Dynamic Model. J Agric Food Chem. 2020 Feb 19;68(7):1884-1895. doi: 10.1021/acs.jafc.9b04796. Epub 2019 Sep 26.
PubMed 31523960Blanco-Morales V, Silvestre RLA, Hernandez-Alvarez E, Donoso-Navarro E, Alegria A, Garcia-Llatas G. Influence of Galactooligosaccharides on the Positive Effect of Plant Sterol-Enriched Beverages on Cardiovascular Risk and Sterol Colon Metabolism. J Agric Food Chem. 2022 Jan 19;70(2):532-542. doi: 10.1021/acs.jafc.1c06120. Epub 2022 Jan 11.
PubMed 35012310Caudet J, Trelis M, Cifre S, Tapia G, Soriano JM, Rodrigo R, Merino-Torres JF. Do Intestinal Unicellular Parasites Have a Role in the Inflammatory and Redox Status among the Severely Obese? Antioxidants (Basel). 2022 Oct 23;11(11):2090. doi: 10.3390/antiox11112090.
PubMed 36358463Heggen E, Kirkhus B, Pedersen JI, Tonstad S. Effects of margarine enriched with plant sterol esters from rapeseed and tall oils on markers of endothelial function, inflammation and hemostasis. Scand J Clin Lab Invest. 2015 Apr;75(2):189-92. doi: 10.3109/00365513.2014.992040. Epub 2015 Jan 1.
PubMed 25553599Oliveira Godoy Ilha A, Sutti Nunes V, Silva Afonso M, Regina Nakandakare E, da Silva Ferreira G, de Paula Assis Bombo R, Rodrigues Giorgi R, Marcondes Machado R, Carlos Rocha Quintao E, Lottenberg AM. Phytosterols Supplementation Reduces Endothelin-1 Plasma Concentration in Moderately Hypercholesterolemic Individuals Independently of Their Cholesterol-Lowering Properties. Nutrients. 2020 May 22;12(5):1507. doi: 10.3390/nu12051507.
PubMed 32455866Mannarino E, Pirro M, Cortese C, Lupattelli G, Siepi D, Mezzetti A, Bertolini S, Parillo M, Fellin R, Pujia A, Averna M, Nicolle C, Notarbartolo A. Effects of a phytosterol-enriched dairy product on lipids, sterols and 8-isoprostane in hypercholesterolemic patients: a multicenter Italian study. Nutr Metab Cardiovasc Dis. 2009 Feb;19(2):84-90. doi: 10.1016/j.numecd.2008.03.012. Epub 2008 Aug 31.
PubMed 18762410Menendez-Carreno M, Steenbergen H, Janssen HG. Development and validation of a comprehensive two-dimensional gas chromatography-mass spectrometry method for the analysis of phytosterol oxidation products in human plasma. Anal Bioanal Chem. 2012 Feb;402(6):2023-32. doi: 10.1007/s00216-011-5432-2. Epub 2011 Oct 5.
PubMed 21972006Musto L, Dura A, Merino-Torres JF, Alegria A, Garcia-Llatas G. Dietary supplementation with plant sterols for obesity management and related metabolic disorders: A randomized, double-blind, placebo-controlled crossover clinical trial. Am J Clin Nutr. 2026 Oct 16:101588. doi: 10.1016/j.ajcnut.2026.101588. Online ahead of print.
PubMed 42887695
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Plant Sterols on Inflammatory, Endothelial Function and Oxidative Stress Markers, Microbiota and Sterol Metabolism in a Cardiovascular Risk Population
- ClinicalTrials.gov ID
- NCT06481020
- Acronym / sponsor ID
- BIONUTEST_2024-0358-1
- Keywords
- Cholesterol LDL, Plant Sterols, Inflammation, Oxidative Stress, Microbiota, Sterol Metabolites, Endothelial function, Bioimpedance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Collaborators
- Hospital Universitario La Fe, University of Bologna
- Study start
- 21 May 2024 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Feb 2025 (estimated)
- First posted
- 1 Jul 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.
Potential cholesterol-lowering effect of a regular intake of a plant sterol (PS)-containing food supplement, in overweight/obese type 1 or 2, normoglycemic/pre-diabetic, with LDL-cholesterol values > 115 mg/dl and not pharmacologically treated participants treated with the PS-containing food supplement or placebo supplement.
Detailed description
Cardiovascular disease (CVD) is the leading cause of death worldwide, with hypercholesterolemia being one of the main risk factors for CVD. The deposition and oxidation of LDL-cholesterol particles triggers a series of molecular events favoring chronic low-grade inflammation, endothelial dysfunction and oxidative stress. This situation promotes atherogenesis thus increasing cardiovascular risk. Obesity favors the secretion of pro-inflammatory mediators and promotes the recruitment of macrophages to adipose tissue, insulin resistance, hyperglycemia and hyperlipidemia, thus increasing the risk of CVD. In addition, obesity has been associated with gut dysbiosis, which in turn is associated with atherosclerosis in some studies. Beneficial effects of PS on LDL-cholesterol and inflammatory, endothelial dysfunction and oxidative stress markers have been reported by several clinical trials. A meta-analysis suggests a lowering effect of PS on body mass index (BMI) in participants with BMI>25. Furthermore, the consumption of PS has been beneficially associated in in vitro studies with changes in intestinal microbial profile, sterol metabolism and short chain fatty acids (SCFA) production. Therefore, the hypothesis is if the consumption of PS as a food supplementation could reduce cardiovascular risk. The present study aims to evaluate the LDL-cholesterol serum levels after regular intake of a food supplement containing PS (2 g/day) in overweight/obese type 1 or 2 patients, normoglycemic /pre-diabetic and with LDL-cholesterol values > 115 mg/dl not pharmacologically treated. This is a crossover study with 21 participants (intake of a food supplement containing PS) and 21 participants (intake of excipient-based placebo), with a first intervention period of 8 weeks. After a 6-week washout period, the treatments are switched, with a second intervention period of 8 weeks. In addition, to the LDL-cholesterol lowering assessment, other biochemical, hematological, inflammatory, endothelial dysfunction and oxidative stress parameters are assessed in serum samples. Moreover, sterol and metabolite profiling in serum and feces, microbiota modulation, anthropometric measurements and body composition, bioimpedance, dietary intake and physical activity questionnaire are evaluated. All parameters are evaluated at the beginning (weeks 0 and 14) and at the end of each intervention period (weeks 8 and 22).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dietary Supplement | Experimental | Dietary Supplement: Plant sterols 2g/dayPS-containing dietary supplement Sachet containing a powdered microencapsulated free plant sterols (2 g ingredient/day) |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboSachet containing the powdered excipients of the dietary supplement |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- BMI: 27-29.9 or 30-39.9
- Plasmatic glucose: < 100mg/dl or 100-125mg/dl
- Glycosylated hemoglobin: < 5.7 or 5.7-6.4
- LDL cholesterol > 115mg/dL
- Serum levels of biochemical and hematological parameters and fat-soluble vitamins within reference ranges.
Key exclusion criteria (9 listed)
- Subjects on cholesterol-lowering pharmacological treatment
- Smokers
- Alcohol consumption above 30 g/day
- Pregnant or lactating women
- Any infection, serious illness or co-morbidity that may affect the bioavailability of PS (e.g., malabsorption, celiac disease, allergies or food intolerances)
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 |
|---|---|---|
| Plant sterols 2g/dayPS-containing dietary supplement Sachet containing a powdered microencapsulated free plant sterols (2 g ingredient/day) during 8 weeks | Dietary supplement | Dietary Supplement |
| PlaceboSachet containing the powdered excipients of the dietary supplement during 8 weeks | Dietary supplement | Placebo |
Primary outcome
Changes in plasmatic LDL-c
Time frame: 0, 8, 14 and 22 weeks
LDL-c, calculated by the Friedewald's formula, with repeated measures (at the beginning and at the end of each period the intervention)
38 secondary outcomes
Changes in plasmatic total cholesterol
Time frame: 0, 8, 14 and 22 weeks
Changes in plasmatic HDL-c
Time frame: 0, 8, 14 and 22 weeks
Changes in plasmatic non-HDL cholesterol
Time frame: 0, 8, 14 and 22 weeks
Changes in plasmatic triglycerides
Time frame: 0, 8, 14 and 22 weeks
Changes in plasmatic Apo A
Time frame: 0, 8, 14 and 22 weeks
Changes in plasmatic Apo B
Time frame: 0, 8, 14 and 22 weeks
Changes in plasmatic fibrinogen
Time frame: 0, 8, 14 and 22 weeks
Changes in plasmatic High-sensitivity C-reactive protein (hsCRP)
Time frame: 0, 8, 14 and 22 weeks
Changes in plasmatic glucose
Time frame: 0, 8, 14 and 22 weeks
Changes in plasmatic insulin
Time frame: 0, 8, 14 and 22 weeks
Changes in plasmatic Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)
Time frame: 0, 8, 14 and 22 weeks
Changes in serum levels of the sterols and metabolites profile
Time frame: 0, 8, 14 and 22 weeks
Changes in feces levels of the sterols and metabolites profile
Time frame: 0, 8, 14 and 22 weeks
Changes in serum interleukin 10 (IL-10)
Time frame: 0, 8, 14 and 22 weeks
Changes in serum interleukin 12p70 (IL-12p70)
Time frame: 0, 8, 14 and 22 weeks
Changes in serum interleukin 1β (IL-1β)
Time frame: 0, 8, 14 and 22 weeks
Changes in serum interleukin 6 (IL-6)
Time frame: 0, 8, 14 and 22 weeks
Changes in serum interleukin 8 (IL-8)
Time frame: 0, 8, 14 and 22 weeks
Changes in serum tumor necrosis factor alpha (TNFα)
Time frame: 0, 8, 14 and 22 weeks
Changes in serum vascular cell adhesion molecule-1 (VCAM-1)
Time frame: 0, 8, 14 and 22 weeks
Changes in serum E-Selectin
Time frame: 0, 8, 14 and 22 weeks
Changes in serum endothelin (ET-1)
Time frame: 0, 8, 14 and 22 weeks
Changes in serum plasminogen activator inhibitor-1(PAI-1)
Time frame: 0, 8, 14 and 22 weeks
Changes in plasmatic LDL-cholesterol oxidation
Time frame: 0, 8, 14 and 22 weeks
Changes in plasmatic 8-isoprostane
Time frame: 0, 8, 14 and 22 weeks
Changes in plasmatic malondialdehyde (MDA)
Time frame: 0, 8, 14 and 22 weeks
Changes in reduced glutathiones (GSH)
Time frame: 0, 8, 14 and 22 weeks
Changes in oxidized glutathione (GSSG)
Time frame: 0, 8, 14 and 22 weeks
Changes in the composition of microbiota in feces
Time frame: 0, 8, 14 and 22 weeks
Changes in feces of short-chain fatty acids (SCFAs)
Time frame: 0, 8, 14 and 22 weeks
Changes in plasmatic levels of cholesterol oxidation products (COPs)
Time frame: 0, 8, 14 and 22 weeks
Changes in body weight (WT)
Time frame: 0, 8, 14 and 22 weeks
Changes in body height (HT)
Time frame: 0, 8, 14 and 22 weeks
Changes in body circumferences
Time frame: 0, 8, 14 and 22 weeks
Changes in Bioelectrical impedance analysis (BIA)
Time frame: 0, 8, 14 and 22 weeks
Assessment of dietary intake
Time frame: 0, 8, 14 and 22 weeks
Evaluation of the physical activity to measure quality of life
Time frame: 0, 8, 14 and 22 weeks
Evaluation of the Mediterranean diet adherence to measure quality of life
Time frame: 0, 8, 14 and 22 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2024.
- Background: PubMed 31523960Blanco-Morales V, Garcia-Llatas G, Yebra MJ, Sentandreu V, Lagarda MJ, Alegria A. Impact of a Plant Sterol- and Galactooligosaccharide-Enriched Beverage on Colonic Metabolism and Gut Microbiota Composition Using an In Vitro Dynamic Model. J Agric Food Chem. 2020 Feb 19;68(7):1884-1895. doi: 10.1021/acs.jafc.9b04796. Epub 2019 Sep 26.
- Background: PubMed 35012310Blanco-Morales V, Silvestre RLA, Hernandez-Alvarez E, Donoso-Navarro E, Alegria A, Garcia-Llatas G. Influence of Galactooligosaccharides on the Positive Effect of Plant Sterol-Enriched Beverages on Cardiovascular Risk and Sterol Colon Metabolism. J Agric Food Chem. 2022 Jan 19;70(2):532-542. doi: 10.1021/acs.jafc.1c06120. Epub 2022 Jan 11.
- Background: PubMed 36358463Caudet J, Trelis M, Cifre S, Tapia G, Soriano JM, Rodrigo R, Merino-Torres JF. Do Intestinal Unicellular Parasites Have a Role in the Inflammatory and Redox Status among the Severely Obese? Antioxidants (Basel). 2022 Oct 23;11(11):2090. doi: 10.3390/antiox11112090.
- Background: PubMed 25553599Heggen E, Kirkhus B, Pedersen JI, Tonstad S. Effects of margarine enriched with plant sterol esters from rapeseed and tall oils on markers of endothelial function, inflammation and hemostasis. Scand J Clin Lab Invest. 2015 Apr;75(2):189-92. doi: 10.3109/00365513.2014.992040. Epub 2015 Jan 1.
- Background: PubMed 32455866Oliveira Godoy Ilha A, Sutti Nunes V, Silva Afonso M, Regina Nakandakare E, da Silva Ferreira G, de Paula Assis Bombo R, Rodrigues Giorgi R, Marcondes Machado R, Carlos Rocha Quintao E, Lottenberg AM. Phytosterols Supplementation Reduces Endothelin-1 Plasma Concentration in Moderately Hypercholesterolemic Individuals Independently of Their Cholesterol-Lowering Properties. Nutrients. 2020 May 22;12(5):1507. doi: 10.3390/nu12051507.
- Background: PubMed 18762410Mannarino E, Pirro M, Cortese C, Lupattelli G, Siepi D, Mezzetti A, Bertolini S, Parillo M, Fellin R, Pujia A, Averna M, Nicolle C, Notarbartolo A. Effects of a phytosterol-enriched dairy product on lipids, sterols and 8-isoprostane in hypercholesterolemic patients: a multicenter Italian study. Nutr Metab Cardiovasc Dis. 2009 Feb;19(2):84-90. doi: 10.1016/j.numecd.2008.03.012. Epub 2008 Aug 31.
- Background: PubMed 21972006Menendez-Carreno M, Steenbergen H, Janssen HG. Development and validation of a comprehensive two-dimensional gas chromatography-mass spectrometry method for the analysis of phytosterol oxidation products in human plasma. Anal Bioanal Chem. 2012 Feb;402(6):2023-32. doi: 10.1007/s00216-011-5432-2. Epub 2011 Oct 5.
- Derived from this study: PubMed 42887695Musto L, Dura A, Merino-Torres JF, Alegria A, Garcia-Llatas G. Dietary supplementation with plant sterols for obesity management and related metabolic disorders: A randomized, double-blind, placebo-controlled crossover clinical trial. Am J Clin Nutr. 2026 Oct 16:101588. doi: 10.1016/j.ajcnut.2026.101588. Online ahead of print.
- Individual participant dataSharing planned: No
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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.
Guadalupe Garcia Llatas, Professor principal investigator
University of Valencia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plant sterols 2g/day in people with Cardiovascular Diseases and Hypercholesterolemia, run by University of Valencia at 1 site in Spain.
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 5 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: status not confirmed, as of the sponsor's last update on 1 Jul 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 Spain. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guadalupe Garcia Llatas, Professor (+34 963543766, guadalupe.garcia@uv.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in plasmatic LDL-c (time frame: 0, 8, 14 and 22 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 NCT06481020, which also lists 8 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 1 Jul 2024.