Beta-glucan-chitin-chitosan Polymer As a Dietary Supplement in Overweight/obese Subjects: Effects on Biomarkers of Cardiovascular Risk.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Adipokines Plasma Levels (Adiponectin, Leptin, Resistin) at Week 12
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body Mass index (BMI): Between 25 and 37 kg / m2
排除标准
- •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.
- •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.
研究组 & 干预措施
βGluCnCs arm
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.
干预措施: βGluCnCs intervention (Dietary Supplement)
Placebo arm
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.
干预措施: Placebo intervention (Dietary Supplement)
结局指标
主要结局
Adipokines Plasma Levels (Adiponectin, Leptin, Resistin) at Week 12
时间窗: Baseline and 12 weeks
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).
Chemerin (RARRES2) Plasma Levels at Week 12
时间窗: Baseline and 12 weeks
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).
A-FABP (Adipocyte Fatty Acid-Binding Protein) Plasma Levels at Week 12
时间窗: Baseline and 12 weeks.
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).
Fasting Blood Glucose Levels at Week 12
时间窗: Baseline and 12 weeks
Biochemical measurement of fasting blood glucose levels after 12 weeks of intervention. Unit of Measure: Concentration (mg/dL).
Fasting Insulin Levels at Week 12
时间窗: Baseline and 12 weeks
Measurement of fasting insulin levels using ELISA after 12 weeks of intervention. Unit of Measure: Concentration (μU/mL).
HOMA-IR (Homeostasis Model Assessment of Insulin Resistance) Index at Week 12
时间窗: Baseline and 12 weeks
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)
Total Cholesterol Levels at Week 12
时间窗: Baseline and 12 weeks
Description: Biochemical measurement of total cholesterol levels after 12 weeks of intervention. Unit of Measure: Concentration (mg/dL).
HDL Cholesterol Levels at Week 12
时间窗: Baseline and 12 weeks.
Biochemical measurement of high-density lipoprotein (HDL) cholesterol levels after 12 weeks of intervention. Unit of Measure: Concentration (mg/dL).
LDL Cholesterol Levels at Week 12
时间窗: Baseline and 12 weeks
Biochemical measurement of low-density lipoprotein (LDL) cholesterol levels after 12 weeks of intervention. Unit of Measure: Concentration (mg/dL).
Triglyceride Levels at Week 12
时间窗: Baseline and 12 weeks
Biochemical measurement of triglyceride levels after 12 weeks of intervention. Unit of Measure: Concentration (mg/dL).
次要结局
- 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)
- Adverse Events (AEs) Monitoring Throughout the Study(Continuous monitoring throughout the 12-week study)