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

NCT06622447 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-10-02

No results posted yet for this study

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

Interventions

DIETARY_SUPPLEMENT

βGluCnCs intervention

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.

DIETARY_SUPPLEMENT

Placebo intervention

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.

Sponsors & Collaborators

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

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-05-09
Primary Completion
2017-10-24
Completion
2017-10-24

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06622447 on ClinicalTrials.gov