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

University of Valencia

Status: Enrolling

Conditions: Prediabetic State; Hypercholesterolemia; Overweight and Obesity; Cardiovascular Diseases

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Plant sterols 2g/day

Study type: Interventional

Funder types: Other

Identifiers

NCT06481020

BIONUTEST_2024-0358-1

PID2019-104167RB-I00 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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).

Enrollment: 42 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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42 participants in 2 patient groups, including a placebo group

Dietary Supplement

Experimental group

Description:

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

Treatment:

Dietary Supplement: Plant sterols 2g/day

Placebo

Placebo Comparator group

Description:

Sachet containing the powdered excipients of the dietary supplement

Treatment:

Dietary Supplement: Placebo