Dietary ExposureQUITOVASCNCT06622447
Beta-glucan-chitin-chitosan Polymer Supplement in Overweight/Obese Subjects: Cardiovascular Risk Biomarkers (QUITOVASC)
A study testing βGluCnCs intervention in people with Dietary Exposure, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Dietary Exposure
- What is being tested?
- βGluCnCs intervention
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 9 May 2017to 24 Oct 2017
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Body Mass index (BMI): Between 25 and 37 kg / m2
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Institut Recerca-Hospital Santa Creu I Sant Pau
Barcelona, Barcelona, 08025
About this study
Official title: Beta-glucan-chitin-chitosan Polymer As a Dietary Supplement in Overweight/obese Subjects: Effects on Biomarkers of Cardiovascular Risk.
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.
Read more
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.
Read the 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.
- Conditions
- Dietary Exposure
- Being tested
- βGluCnCs intervention, Placebo intervention
- Keywords
- β-Glucan, Chitin-chitosan, Fat-binding nutraceutical supplements
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
βGluCnCs interventionDietary 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.
Placebo interventionDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Placebo intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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)
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Baseline and 12 weeks
Secondary outcomes (6)
Plasma Levels of Inflammatory Markers (TNF-alpha, IL-6, hsCRP) at Week 12
Description: Quantification of plasma levels of inflammatory markers (TNF-alpha, IL-6, and high-sensitivity C-reactive protein - hsCRP) using ELISA techniques to assess systemic inflammation.
Unit of Measure: Concentration (pg/mL for TNF-alpha and IL-6; mg/L for hsCRP).
Measured: Baseline and 12 weeks
Plasma Lipid Peroxidation Levels (TBARS) at Week 12
Measurement of plasma lipid peroxidation levels using TBARS (thiobarbituric acid reactive substances) as a marker of oxidative stress.
Unit of Measure: Concentration (μmol/L).
Measured: Baseline and 12 weeks
Plasma Antioxidant Capacity (FRAP) at Week 12
Measurement of plasma antioxidant capacity using the FRAP (Ferric Reducing Ability of Plasma) assay, which reflects the overall redox balance.
Unit of Measure: Concentration (μmol/L).
Measured: Baseline and 12 weeks
Erythrocyte Superoxide Dismutase (SOD) Activity at Week 12
Measurement of erythrocyte superoxide dismutase (SOD) activity as a marker of enzymatic antioxidant defense.
Unit of Measure: Activity (U/mg Hb).
Measured: Baseline and 12 weeks
LDL Resistance to Oxidation (Diene Measurement) at Week 12
Measurement of the resistance of low-density lipoprotein (LDL) to oxidation by assessing the formation of conjugated dienes as a marker of oxidative stress on lipoproteins.
Unit of Measure: Concentration (μmol conjugated dienes/mg LDL).
Measured: Baseline and 12 weeks
Adverse Events (AEs) Monitoring Throughout the Study
Recording and classification of adverse events (AEs), including severity grading and causal relationship to the dietary intervention. Adverse events will be documented individually for each subject and treatment group.
Unit of Measure: Number of participants with treatment-related adverse events, severity graded according to protocol.
Measured: Continuous monitoring throughout the 12-week study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2024
- Study start9 May 2017
- Primary completion24 Oct 2017
- Study completion24 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dietary ExposureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06622447
- Sponsor's protocol ID
- ICCC-14 QUITOVASC
- Acronym
- QUITOVASC
- Status last verified
- Jul 2024
- First submitted
- 5 Sep 2024
- Last updated
- 2 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No