A Randomized, Double-blind, Placebo-controlled Pilot Study to Evaluate the Systemic Effect on Immunoinflammatory and Metabolic Status of an Oral Supplementation With AM3 in Patients With Metabolic Syndrome.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Change in serum cytokines.
研究概览
简要总结
The goal of this pilot study is to learn about the effect of the nutritional supplementation based on AM3 in combination with probiotics on imflammatory and metabolic mediators in adult subjects diagnosed with metabolic syndrome.
The hypothesis the investigators are testing focuses on the fact that the continued use of the nutritional supplement with AM3 and probiotics is capable of minimizing the risk factors associated with metabolic syndrome, by reducing the development of the derived chronic pathologies.
A total of 48 subjects with a diagnosis of metabolic syndrome is planned to be recruited from two investigational sites in the Comunity of Madrid (Spain). These subjects will be randomized into three treatment groups (active, placebo, and control). The dosage will be of 2 capsules/day in a single intake in the morning for 12 weeks. Two interventional visits are planned to be performed: at baseline and at week 12.
详细描述
This is a randomized, double-blind, placebo-controlled, pilot study. The primay objective is to evaluate the systemic effect of this new nutritional supplement with AM3 and probiotics on the immuno-inflammatory and metabolic status against metabolic syndrome.
The secondary objectives are:
- To determine the efficacy of the administration of a new food supplement for MS through the improvement of biochemical variables.
- To evaluate the efficacy of the administration of a new dietary supplement on the impact on body composition parameters.
- To evaluate the patient's quality of life.
Adult subjects (aged between 18 and 75 years) will randomly be assigned into one of these three treatment groups:
- Active: patients who will receive the study treatment, consisting of the combination of AM3 and the probiotic SynBalance Metsyn.
- Placebo: patients who will receive placebo (starch capsules), with no active ingredient.
- Control: patients to be treated with AM3 capsules alone (no probiotics).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women aged 18-75 years at the time of signing the informed consent form.
- •Diagnosis of metabolic syndrome, defined as: central obesity, elevation of blood glucose by ≥100 mg/dl, glycosylated hemoglobin between 5.7 and 6.4%, low HDL cholesterol levels < 40 mg/dl in men and < 50 mg/dl in women, and high levels of triglycerides, being higher than 150 mg/dl.
- •If the patient is being treated with metformin, lipid-lowering treatment with statins or treatment with antihypertensives, he/she must have a stable dose at the time of inclusion.
排除标准
- •Smokers or with history of alcoholism or drug abuse .
- •To have hypertriglyceridemia (> 500 mg/dL).
- •Uncontrolled arterial hypertension, as per investigator's criteria.
- •To have undergone bariatric surgery over the last 24 months that according to investigator's criteria, this might interfere with his/her participation in the study.
- •Diagnosis of chronic diseases that according to investigator's criteria, this might interfere with his/her participation in the study.
- •Presence of renal insufficiency (glomerular filtration rate below 30 ml/minute).
- •Presence of severe respiratory insufficiency (PaO2 less than 60 mmHg or PaCO2 greater than 50 mmHg).
- •Presence of heart failure (LVEF <30% and RVEF <35%).
- •Presence of the following diseases in an unstable manner, according to the investigator's criteria: chronic obstructive disease, inflammatory bowel disease, intestinal malabsorption syndrome, systemic autoimmune diseases, rheumatoid arthritis, spondyloarthritis, psoriasis, and chronic inflammatory skin diseases.
- •Active or chronic severe unstable infections that, in medical criteria, may interfere with patients' safety.
- •Disease-related malnutrition.
- •Endocrinologic unestable or uncontrolled diseases that in medical criteria, present with manifestations in pituitary, adrenal or thyroid function.
- •Immunosuppressive or corticosteroid treatment in the last 3 months.
- •Treatment with semaglutide and tirzepatide.
- •Pregnant women (or intending to become pregnant) or breast-feeding women.
结局指标
主要结局
Change in serum cytokines.
时间窗: Baseline and week 12
Circulating cytokine levels will be determined at baseline and at week 12 to assess the effect on inflammatory mediators.
次要结局
- Change in monocytes and natural killer cells levels.(Baseline and week 12)
- Change in hip circumference(Baseline and week 12)
- Change in serum glucose(Baseline and week 12)
- Change in serum bilirrubin.(Baseline and week 12)
- Change in serum lipids(Baseline and week 12)
- Change in weight(Baseline and week 12)
- Change in body mass index(Baseline and week 12)
- Change in serum uric acid.(Baseline and week 12)
- Change in serum potasium.(Baseline and week 12)
- Change in waist circumference(Baseline and week 12)
- Change in total body fat content(Baseline and week 12)
- Change in serum sodium.(Baseline and week 12)
- Change in blood pressure(Baseline and week 12.)
- Change in patient's quality of life, assessed by the SF-12v2 score.(Baseline and week 12)