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
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
More Related Trials
-
Beetroot Juice and Postprandial Vascular Activity
NCT01559441 ·Status: COMPLETED ·Phase: NA
-
Effects of Beta-glucan on Energy Intake and Satiety
NCT02637388 ·Status: UNKNOWN ·Phase: NA
-
Effectiveness of Sacha Inchi Supplementation on Postprandial Inflammation
NCT02886169 ·Status: COMPLETED ·Phase: NA
-
Efficacy and Safety of Fermented Barley on Decrement of Body Fat in Obese Subjects
NCT01402128 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
Enriched Canned Tuna With Fibre or Polyphenols on Satiety
NCT03921580 ·Status: COMPLETED ·Phase: NA
-
Gut Microbiota as a Therapeutic Target for CVD
NCT03441802 ·Status: COMPLETED ·Phase: NA
-
Inulin-type Fructans-rich Vegetables, Obesity, Gut Microbiota
NCT03852069 ·Status: COMPLETED ·Phase: NA
-
Effect of Tomato Soffritto Intake on Biomarkers of Cardiovascular Disease in an Overweight and Obesity
NCT06161883 ·Status: COMPLETED ·Phase: NA
-
Bioactive Dietary Fibres and Obesity
NCT03350958 ·Status: COMPLETED ·Phase: NA
-
A Study Evaluating the Effects of a High Viscosity Non-starch Polysaccharide (PolyGlycopleX® - PGX®) on Glycemic Control, Cardiometabolic Risk Factors and Weight Loss in Overweight and Obese Type II Diabetics
NCT01644201 ·Status: TERMINATED ·Phase: PHASE3
-
Impact of Supplemental Fiber on Gut and Vascular Health Related in Obesity Phenotypes
NCT07095426 ·Status: RECRUITING ·Phase: NA
-
The Effect of Oral Alpha-Cyclodextrin on Fecal Fat Excretion
NCT01910558 ·Status: WITHDRAWN ·Phase: NA
-
Diet and COVID-19 Vaccination
NCT05163743 ·Status: UNKNOWN ·Phase: NA
-
Acute Medium Chain Triglycerides (MCT) Intake in Young and Older Participants
NCT03830268 ·Status: COMPLETED ·Phase: NA
-
Compare Effects of a Soluble Fiber on Weight and Blood Cholesterol
NCT00682916 ·Status: COMPLETED ·Phase: NA
-
Health Benefits of Functional Meat (With n-3 Fatty Acids and Rosemary Extract) on Low Risk for Cardiovascular Disease People
NCT01999088 ·Status: COMPLETED ·Phase: PHASE4
-
Effect of Consumption of Caraway on Treatment of Obesity
NCT01833377 ·Status: COMPLETED ·Phase: NA
-
Use of Nutrigenomic Models for the Personalized Treatment With Medical Foods in Obese People
NCT02837367 ·Status: UNKNOWN ·Phase: NA
-
Low Carb Diets & Exercise for Cardiovascular Disease (CVD) Reduction
NCT01176084 ·Status: COMPLETED ·Phase: NA
-
Low Fat Plant-Based Supplemented Diet Effects on Risk Factors for Chronic Non-communicable Diseases
NCT02905448 ·Status: COMPLETED ·Phase: NA
-
The Impact of Faba Bean Rich Bread on Iron Status, Postprandial Lipaemia and Satiety
NCT06466746 ·Status: RECRUITING ·Phase: NA
-
Isolating & Exploiting the Mechanisms That Link Breakfast to Human Health - Acute
NCT03866720 ·Status: COMPLETED ·Phase: NA
-
The Effect of Macronutrients in the Diet on Digestive and Cardiovascular Health
NCT01510223 ·Status: COMPLETED ·Phase: NA
-
Effect of Low Calorie Diet With Rice Bran Oil on Cardiovascular Risk Factors in Hyperlipidemic Patients
NCT01600313 ·Status: UNKNOWN ·Phase: NA
-
The Impact of Short-Chain Fatty Acids on Gut Hormone Release After Delivery in the Small and Large Intestine of Healthy Volunteers
NCT06686888 ·Status: COMPLETED ·Phase: NA