Evaluation of the Antioxidant and Immunomodulatory Effect of a β-glucan Fiber From Saccharomyces Cerevisiae in Healthy Adults, Medellín - Antioquia 2021-2022
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Antioxidant capacity
研究概览
简要总结
Β-glucans are linear polymers of glucose of high molecular weight that are found naturally in the cell wall of various living organisms such as bacteria, yeast, fungi and plants; They are widely used in food companies as texturizers.
Scientific studies suggest that the consumption of β-glucans would be associated with benefits for human health such as reducing the risk of cardiovascular diseases and strengthening the immune system. These effects depend on their source of origin; those from cereals have been attributed beneficial metabolic properties and those that come from yeast immunostimulating properties.
Yeast β-glucans are believed to be potent immunomodulators with effects on innate and adaptive immunity. This effect could be due to the ability to stimulate receptors of the immune system present in the membrane of enterocytes, M cells and dendritic cells, improving the phagocytic activity of macrophages and the antimicrobial activity of mononuclear cells and neutrophils.
Due to this property, β-glucans are being used more and more for the development of functional foods in several countries of the world. However, the effect of yeast β-glucans on the stimulation of the immune response has not yet been accurately documented; Therefore, the present investigation aims to establish the performance of a β-glucan fiber from S. cerevisiae in antioxidant and immunomodulatory activity in healthy volunteers.
详细描述
Background
Β-glucans are high molecular weight glucose polymers (polysaccharides) naturally present in the cell wall of various living organisms such as bacteria, yeast, fungi and plants. Some studies show that β-glucans have antioxidant activity and stimulate the immune system in animals and humans.
On the other hand, the physiological metabolism in living beings generates free radicals that can endanger cell integrity if they are not controlled properly. Free radicals are collectively known as Reactive Oxygen Species (ROS) and have the ability to produce significant oxidative damage to cellular structures that can increase under environmental stress. Free radicals impair tissue function, contribute to aging and the development of chronic and chronic degenerative diseases.
To counteract the action of free radicals, antioxidants are used whose function is to maintain or restore cellular balance. An alternative for this are β-glucans since they have protective properties against oxidative damage, the antioxidant effect they exert is indirect and is produced by improving the expression and production of antioxidant systems by the body itself.
Various studies focused on antioxidant activity indicate that β-glucans from mushrooms constitute a potential natural source of antioxidants, especially associated with regular consumption.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double blind trial. Research product blinding will be maintained using one label for both products (fiber and placebo) and the same capsules for both.
Subjects, who collect the data (eg, Investigator and coordinator) and those who evaluate the data (eg, Statistician) will be blinded. One or more pharmacists / vaccine administrators designated by the facility will not be blinded. These designated unblinded individuals will maintain investigational vaccine blindness and will not participate in the safety assessment of the subjects.
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women aged ≥18 and ≤45 years without abnormal findings at the time of physical examination
- •Tests of creatinine, transaminases, lipid profile, glycemia and hemogram with ranges of normality according to laboratory reference values and / or at the discretion of the researcher
- •Body Mass Index (BMI) between 18.5 and 25 kg / m2
- •In the opinion of the researcher, the participant is able to understand and comply with the protocol
排除标准
- •Women with a positive pregnancy test during the screening process or who do not agree with the use of a contraceptive method until day 90 post-treatment
- •Women who are breastfeeding
- •Clinically significant pathological history such as kidney disease, hypertension, diabetes, anemia, autoimmune or psychiatric diseases, among others that may affect the development or results of the study.
- •Manifest eating styles other than the omnivore
- •Have food restrictions derived from allergic, metabolic, dermatological diseases, lithiasis, irritable bowel and / or health conditions that imply permanent modification in diet
- •Consumption of a vitamin or nutritional supplement
- •Any condition that, in the opinion of the investigator, may affect the development of the study.
研究组 & 干预措施
consumption of 250 mg of β-glucan
Patients with oral consumption of 250 mg (one capsule) of β-glucan from Yeast Plus once a day for 84 days without interruption.
干预措施: Yeast β-glucan fiber (Dietary Supplement)
consumption of 500 mg of β-glucan
Patients with oral consumption of 500 mg (two capsules) of β-glucan from Yeast Plus once a day for 84 days without interruption.
干预措施: Yeast β-glucan fiber (Dietary Supplement)
200 mg or 400 mg placebo
Placebo patients, with oral soy protein consumption, half of the group 200 mg (one capsule) and the remaining 400 mg (two capsules) once a day for 84 days without interruption
干预措施: Placebo (Other)
结局指标
主要结局
Antioxidant capacity
时间窗: Day 140
Evaluation of antioxidant capacity of β-glucan Fiber through analysis of results of tests from Baseline level compared to day 42, day 84 and day 140.
Immunomodulatory capacity
时间窗: Day 140
Evaluation of immunomodulatory capacity of β-glucan Fiber through analysis of results of tests from Baseline level compared to day 42, day 84 and day 140.
次要结局
- Metabolic benefit(Day 140)
- Metabolid benefit(Day 140)