Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06622447
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-09-05
Brief Title:
Beta-glucan-chitin-chitosan Polymer Supplement in OverweightObese Subjects Cardiovascular Risk Biomarkers QUITOVASC
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Beta-glucan-chitin-chitosan Polymer As a Dietary Supplement in Overweightobese Subjects Effects on Biomarkers of Cardiovascular Risk
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
QUITOVASC
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 chitinchitosan 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-glucanchitinchitosan 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-GlucanChitin-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 celluloseThe effects were evaluated on lipid profile lipoprotein subclass pattern and functionality and molecular markers associated with insulin resistance
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 chitinchitosan 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-glucanchitinchitosan 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-GlucanChitin-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 celluloseThe effects were evaluated on lipid profile lipoprotein subclass pattern and functionality and molecular markers associated with insulin resistance
Detailed Description:
Sample size N40 intervention group N20 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 N60 and overweight body mass index BMI 27-299 kgm2 or obesity class 1 BMI 30-349 kgm2
The study was approved by the Human Ethical Review Committee of the Hospital Sant Pau in Barcelona register number17046 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 14 gstick 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
The study refers to healthy adult men and women aged 25-60 years N60 and overweight body mass index BMI 27-299 kgm2 or obesity class 1 BMI 30-349 kgm2
The study was approved by the Human Ethical Review Committee of the Hospital Sant Pau in Barcelona register number17046 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 14 gstick 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None