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

NCT06481020 | Recruiting

• 2 other identifiers: BIONUTEST_2024-0358-1PID2019-104167RB-I00
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Diseases; Hypercholesterolemia; Prediabetic State; Overweight and Obesity

Keywords

Cholesterol LDL; Plant Sterols; Inflammation; Oxidative Stress; Microbiota; Sterol Metabolites; Endothelial function; Bioimpedance; Dietary Intake; Physical Activity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (38)

• Changes in plasmatic total cholesterol

  0, 8, 14 and 22 weeks

• Changes in plasmatic HDL-c

  0, 8, 14 and 22 weeks

• Changes in plasmatic non-HDL cholesterol

  0, 8, 14 and 22 weeks

• Changes in plasmatic triglycerides

  0, 8, 14 and 22 weeks

• Changes in plasmatic Apo A

  0, 8, 14 and 22 weeks

Study Arms (2)

Dietary Supplement

EXPERIMENTAL

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

Dietary Supplement: Plant sterols 2g/day

Placebo

PLACEBO COMPARATOR

Sachet containing the powdered excipients of the dietary supplement

Dietary Supplement: Placebo

Interventions

Plant sterols 2g/day DIETARY_SUPPLEMENT

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

Dietary Supplement

Placebo DIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Valencia: lead
• Hospital Universitario La Fe: collaborator
• University of Bologna: collaborator

Study Sites (1)

Hospital Universitario y Politécnico La Fe de Valencia

Valencia, 46026, Spain

RECRUITING

Related Publications (7)

• 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.

  PMID: 31523960 BACKGROUND

• 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.

  PMID: 35012310 BACKGROUND

• Caudet 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.

  PMID: 36358463 BACKGROUND

• Heggen 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.

  PMID: 25553599 BACKGROUND

• Oliveira 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.

  PMID: 32455866 BACKGROUND

• 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.

  PMID: 18762410 BACKGROUND

• 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.

  PMID: 21972006 BACKGROUND

MeSH Terms

Conditions

Cardiovascular Diseases; Hypercholesterolemia; Prediabetic State; Overweight; Obesity; Inflammation; Motor Activity

Interventions

Phytosterols

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Endocrine System Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes; Behavior

Intervention Hierarchy (Ancestors)

Sterols; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Membrane Lipids; Lipids; Phytochemicals; Biological Factors

Study Officials

• Guadalupe Garcia Llatas, Professor

  University of Valencia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guadalupe Garcia Llatas, Professor

CONTACT

+34 963543766; guadalupe.garcia@uv.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: June 12, 2024
• First Posted: July 1, 2024
• Study Start: May 21, 2024
• Primary Completion: December 1, 2024
• Study Completion: February 1, 2025
• Last Updated: July 1, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)