Plant Sterols on Cardiovascular Markers, Microbiota and Sterol Metabolism (Cardiofoodsterol)
NCT Number: NCT06481020
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cardiovascular Diseases|Hypercholesterolemia|Prediabetic State|Overweight and Obesity
Interventions: DIETARY_SUPPLEMENT: Plant sterols 2g/day|DIETARY_SUPPLEMENT: Placebo
Sponsor: University of Valencia
Collaborators: Hospital Universitario La Fe|University of Bologna
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 42
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-05-21
Completion Date: 2025-02
Locations: Hospital Universitario y Politécnico La Fe de Valencia, Valencia, 46026, Spain

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 supplement.

Primary Outcome Measures: 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), 0, 8, 14 and 22 weeks
Secondary Outcome Measures: 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), 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), 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), 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), 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), 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, 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), 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), 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), 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, 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), 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), 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), 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), 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), 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), 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), 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), 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), 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), 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), 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, 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), 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), 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), 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, 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), 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), 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), 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), 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), 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), 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), 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), 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), 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), 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), 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), 0, 8, 14 and 22 weeks