Plant Sterols on Cardiovascular Markers, Microbiota and Sterol Metabolism (Cardiofoodsterol)

NCT ID: NCT06481020

Last Updated: 2024-07-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-21
• Study Completion Date: 2025-02-28

Brief 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.

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).

Conditions

Cardiovascular Diseases; Hypercholesterolemia; Prediabetic State; Overweight and Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

Dietary Supplement

PS-containing dietary supplement Sachet containing a powdered microencapsulated free plant sterols (2 g ingredient/day)

Group Type: EXPERIMENTAL

Plant sterols 2g/day

Intervention Type: DIETARY_SUPPLEMENT

PS-containing dietary supplement Sachet containing a powdered microencapsulated free plant sterols (2 g ingredient/day) during 8 weeks

Placebo

Sachet containing the powdered excipients of the dietary supplement

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Sachet containing the powdered excipients of the dietary supplement during 8 weeks

Interventions

Plant sterols 2g/day

PS-containing dietary supplement Sachet containing a powdered microencapsulated free plant sterols (2 g ingredient/day) during 8 weeks

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Sachet containing the powdered excipients of the dietary supplement during 8 weeks

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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
• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Universitario La Fe

OTHER

Sponsor Role: collaborator

University of Bologna

OTHER

Sponsor Role: collaborator

University of Valencia

OTHER

Sponsor Role: lead

Responsible Party

Guadalupe García Llatas

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Guadalupe Garcia Llatas, Professor

Role: PRINCIPAL_INVESTIGATOR

University of Valencia

Locations

Hospital Universitario y Politécnico La Fe de Valencia

Valencia, , Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Guadalupe Garcia Llatas, Professor

Role: CONTACT

guadalupe.garcia@uv.es

+34 963543766

Facility Contacts

Juan Francisco Merino Torres

Role: primary

References

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.

Reference Type: BACKGROUND

PMID: 31523960 (View on PubMed)

Blanco-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.

Reference Type: BACKGROUND

PMID: 35012310 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 36358463 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 25553599 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 32455866 (View on PubMed)

Mannarino 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.

Reference Type: BACKGROUND

PMID: 18762410 (View on PubMed)

Menendez-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.

Reference Type: BACKGROUND

PMID: 21972006 (View on PubMed)

Other Identifiers

PID2019-104167RB-I00

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

BIONUTEST_2024-0358-1

Identifier Type: -

Identifier Source: org_study_id