Clinical trial NCT06622447: Beta-glucan-chitin-chitosan Polymer Supplement in Overweight/Obese Subjects: Cardiovascular Risk Biomarkers (QUITOVASC)
Official title: Beta-glucan-chitin-chitosan Polymer As a Dietary Supplement in Overweight/obese Subjects: Effects on Biomarkers of Cardiovascular Risk.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dietary Exposure
Keywords: β-Glucan
Chitin-chitosan
Fat-binding nutraceutical supplements
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
First posted: 2024-10-02
Enrollment: 60
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The intervention trial consisted of a prospective, randomized, two parallel arms, double-blinded, single-center study with 14-week of durantion, which includes 2-weeks run-in period and 12 weeks intervention period (βGluCnCs or placebo group)
Primary purpose: BASIC_SCIENCE

Brief summary: Reducing caloric intake and increasing energy expenditure as a strategy against overweight and its associated dyslipidaemia to reduce the risk of cardiovascular disease currently has a high failure rate.

For this reason, the consumption of food supplements capable of reducing intestinal fat absorption is seen as a tool of great interest.

The vast majority of existing fat-binder compounds have polymers such as chitin/chitosan as their active product. However, these are mainly derived from the exoskeleton of crustaceans, so their extraction and composition are highly variable, depending on season, geography and age.

The food supplement studied here refers to a new selective fat binder compound consisting mainly of a β-glucan/chitin/chitosan polymer (βGluQnQs), which is derived from the cell wall of the yeast Saccharomyces cerevisiae, a residue produced during brewing.

In vitro studies show that βGluCnCs has a high selective binding capacity for saturated fats with minimal impact as a ligand for omega-3 polyunsaturated fatty acids. In vivo tests in animal models and two pilot studies at clinical level corroborate the beneficial and selective effect of βGluCnCs supplementation in reducing saturated fat absorption and body weight reduction, with no adverse nutritional effects.

This study aimed to assess the impact of consuming a polysaccharide-rich compound containing β-Glucan/Chitin-Chitosan (βGluCnCs) fraction on the lipid profile and biomarkers of adipose tissue metabolism at plasma level, as well as on oxidative stress and circulating pro-inflammatory status in overweight or obese individuals, thereby reducing their cardiovascular risk.

The βGluCnCs compound was administered continuously and regularly for 12 weeks, compared to a placebo control that received microcrystalline cellulose.The effects were evaluated on lipid profile, lipoprotein subclass pattern and functionality and molecular markers associated with insulin resistance.

Detailed description: Sample size (N=40 intervention group / N=20 placebo group) was calcultaded according results of previous studies where a sample size of less than 40 subjects in the intervention group was sufficient to show differences in the level of LDL oxidation and variables associated the degree of obesity.

The study refers to healthy adult men and women aged 25-60 years (N=60) and overweight (body mass index (BMI) 27-29.9 kg/m2) or obesity class 1 (BMI 30-34.9 kg/m2).

The study was approved by the Human Ethical Review Committee of the Hospital Sant Pau in Barcelona (register number:17/046). Informed written consent was obtained from all participants before their inclusion in the study. To confirm health status, all subjects underwent a complete physical examination conducted by the study physician.

The study lasted 14 weeks that were structured in 2 weeks of run-in and 12 weeks of intervention period divided into 4 phases of 4 weeks.

During the intervention period, study participants received 1 stick (1.4 g/stick) of βGluCnCs or placebo product (microcrystalline cellulose) three times daily for a total of 12 weeks.

Volunteers visited the centre at baseline, every 4 weeks (day 0, week 4, week 8) and at the end of the intervention period (week 12). Lifestyle and anthropometric measures were recorded, and blood samples were collected early in the morning after a 12-hour fast.

Compliance was monitored by weekly telephone contact with participants and interviews at the end of each 4-week phase of the intervention period.

Eligibility criteria: Inclusion Criteria:

* Body Mass index (BMI): Between 25 and 37 kg / m2

Exclusion Criteria:

* Eating disorders.
* Cardiovascular risk factors (e.g. hyperlipidemia, hypertension, and diabetes under pharmacological treatment).
* History of ischemic heart disease, arrhythmia, previous strokes, or peripheral vascular disease.
* Alcohol consumption exceeding 60 grams/day.
* Renal insufficiency (creatinine \&gt; 2mg/dl).
* Neoplasia.
* Systemic disease.
* Psychiatric illness under psychotropic drug treatment.
* Unstabilized thyroid pathology.
* Having followed or were following a hypocaloric diet or consuming dietary supplements for weight or constipation control or for cholesterol control for at least 2 months earlier to study inclusion.
* Food allergy or sensitivity.
* Pregnancy or breastfeeding.
* Currently undergoing treatment with non-steroidal anti-inflammatory drugs, antiplatelet agents, fibrates, or statins.

Primary outcomes:
measure: Adipokines Plasma Levels (Adiponectin, Leptin, Resistin) at Week 12
timeFrame: Baseline and 12 weeks
measure: Chemerin (RARRES2) Plasma Levels at Week 12
timeFrame: Baseline and 12 weeks
measure: A-FABP (Adipocyte Fatty Acid-Binding Protein) Plasma Levels at Week 12
timeFrame: Baseline and 12 weeks.
measure: Fasting Blood Glucose Levels at Week 12
timeFrame: Baseline and 12 weeks
measure: Fasting Insulin Levels at Week 12
timeFrame: Baseline and 12 weeks
measure: HOMA-IR (Homeostasis Model Assessment of Insulin Resistance) Index at Week 12
timeFrame: Baseline and 12 weeks
measure: Total Cholesterol Levels at Week 12
timeFrame: Baseline and 12 weeks
measure: HDL Cholesterol Levels at Week 12
timeFrame: Baseline and 12 weeks.
measure: LDL Cholesterol Levels at Week 12
timeFrame: Baseline and 12 weeks
measure: Triglyceride Levels at Week 12
timeFrame: Baseline and 12 weeks
Secondary outcomes:
measure: Plasma Levels of Inflammatory Markers (TNF-alpha, IL-6, hsCRP) at Week 12
timeFrame: Baseline and 12 weeks
measure: Plasma Lipid Peroxidation Levels (TBARS) at Week 12
timeFrame: Baseline and 12 weeks
measure: Plasma Antioxidant Capacity (FRAP) at Week 12
timeFrame: Baseline and 12 weeks
measure: Erythrocyte Superoxide Dismutase (SOD) Activity at Week 12
timeFrame: Baseline and 12 weeks
measure: LDL Resistance to Oxidation (Diene Measurement) at Week 12
timeFrame: Baseline and 12 weeks
measure: Adverse Events (AEs) Monitoring Throughout the Study
timeFrame: Continuous monitoring throughout the 12-week study
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Institut Recerca-Hospital Santa Creu I Sant Pau
Study officials:
References: