Beta-glucan-chitin-chitosan Polymer Supplement in Overweight/Obese Subjects: Cardiovascular Risk Biomarkers (QUITOVASC)

NCT06622447 | Completed DMC

• 1 other identifier: ICCC-14 QUITOVASC
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Dietary Exposure

Keywords

β-Glucan; Chitin-chitosan; Fat-binding nutraceutical supplements

Outcome Measures

Primary Outcomes (10)

• Adipokines Plasma Levels (Adiponectin, Leptin, Resistin) at Week 12

  Quantification of plasma levels of adiponectin, leptin, and resistin using ELISA assays to assess changes in adipose tissue metabolism after 12 weeks of intervention. Unit of Measure: Concentration (ng/mL).

  Baseline and 12 weeks

• Chemerin (RARRES2) Plasma Levels at Week 12

  Measurement of plasma levels of chemerin (RARRES2) using ELISA after 12 weeks of intervention to evaluate its association with adipose tissue metabolism and obesity. Unit of Measure: Concentration (ng/mL).

  Baseline and 12 weeks

• A-FABP (Adipocyte Fatty Acid-Binding Protein) Plasma Levels at Week 12

  Quantification of plasma levels of A-FABP using ELISA after 12 weeks of intervention, as a marker for adipose tissue metabolism. Unit of Measure: Concentration (ng/mL).

  Baseline and 12 weeks.

• Fasting Blood Glucose Levels at Week 12

  Biochemical measurement of fasting blood glucose levels after 12 weeks of intervention. Unit of Measure: Concentration (mg/dL).

  Baseline and 12 weeks

• Fasting Insulin Levels at Week 12

  Measurement of fasting insulin levels using ELISA after 12 weeks of intervention. Unit of Measure: Concentration (μU/mL).

  Baseline and 12 weeks

• HOMA-IR (Homeostasis Model Assessment of Insulin Resistance) Index at Week 12

  Calculation of the HOMA-IR index based on fasting insulin and fasting glucose levels after 12 weeks of intervention. Unit of Measure: HOMA-IR value (dimensionless)

  Baseline and 12 weeks

• Total Cholesterol Levels at Week 12

  Description: Biochemical measurement of total cholesterol levels after 12 weeks of intervention. Unit of Measure: Concentration (mg/dL).

  Baseline and 12 weeks

• HDL Cholesterol Levels at Week 12

  Biochemical measurement of high-density lipoprotein (HDL) cholesterol levels after 12 weeks of intervention. Unit of Measure: Concentration (mg/dL).

  Baseline and 12 weeks.

• LDL Cholesterol Levels at Week 12

  Biochemical measurement of low-density lipoprotein (LDL) cholesterol levels after 12 weeks of intervention. Unit of Measure: Concentration (mg/dL).

  Baseline and 12 weeks

• Triglyceride Levels at Week 12

  Biochemical measurement of triglyceride levels after 12 weeks of intervention. Unit of Measure: Concentration (mg/dL).

  Baseline and 12 weeks

Secondary Outcomes (6)

• Plasma Levels of Inflammatory Markers (TNF-alpha, IL-6, hsCRP) at Week 12

  Baseline and 12 weeks

• Plasma Lipid Peroxidation Levels (TBARS) at Week 12

  Baseline and 12 weeks

• Plasma Antioxidant Capacity (FRAP) at Week 12

  Baseline and 12 weeks

• Erythrocyte Superoxide Dismutase (SOD) Activity at Week 12

  Baseline and 12 weeks

• LDL Resistance to Oxidation (Diene Measurement) at Week 12

  Baseline and 12 weeks

Study Arms (2)

βGluCnCs arm

EXPERIMENTAL

After a two-week run-in phase, participants (N=60) were randomly assigned to the βGluCnCs arm (N=40) During the intervention period, βGluCnCs arm participants received 1 stick (1.4 g/stick) of βGluCnCs product three times daily for a total of 12 weeks.

Dietary Supplement: βGluCnCs intervention

Placebo arm

EXPERIMENTAL

After a two-week run-in phase, participants (N=60) were randomly assigned to the placebo arm (N=20) During the intervention period, placebo arm participants received 1 stick (1.4 g/stick) of placebo product (microcrystalline cellulose ) three times daily for a total of 12 weeks.

Dietary Supplement: Placebo intervention

Interventions

βGluCnCs intervention DIETARY_SUPPLEMENT

The intervention trial consisted of a prospective, randomized, two parallel arms, double-blinded, single-center study with 16-week of duration. Individuals were subjected to a 2 weeks run-in period. Following this, the population was randomly allocated into βGluCnCs intervention (N=40). During the intervention period, study participants received βGluCnCs product daily for a total of 12 weeks.

βGluCnCs arm

Placebo intervention DIETARY_SUPPLEMENT

The intervention trial consisted of a prospective, randomized, two parallel arms, double-blinded, single-center study with 16-week of duration. Individuals were subjected to a 2 weeks run-in period. Following this, the population was randomly allocated into placebo intervention (N=20). During the intervention period, study participants received βGluCnCs product daily for a total of 12 weeks.

Placebo arm

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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 \> 2mg/dl).
• Neoplasia.
• Systemic disease.
• Psychiatric illness under psychotropic drug treatment.
• Unstabilized thyroid pathology.
• Food allergy or sensitivity.
• Pregnancy or breastfeeding.
• Currently undergoing treatment with non-steroidal anti-inflammatory drugs, antiplatelet agents, fibrates, or statins.

Sponsors & Collaborators

• Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau: lead

Study Sites (1)

Institut Recerca-Hospital Santa Creu I Sant Pau

Barcelona, Barcelona, 08025, Spain

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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)

Study Record Dates

• First Submitted: September 5, 2024
• First Posted: October 2, 2024
• Study Start: May 9, 2017
• Primary Completion: October 24, 2017
• Study Completion: October 24, 2017
• Last Updated: October 2, 2024

Record last verified: 2024-07

Locations

ES (1)