ISRCTN12319920进行中（未招募）未知
Interventional study to verify the efficacy of ALFALIFE™ administration in potentiating the effects of diet in patients with low-grade inflammation, and its associate conditions as prediabetes, diabetes, overweight and inflammatory response to viral infections
Digitcal S.r.l.0 个研究点目标入组 24 人开始时间: 2020年6月1日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Patients with non-optimal ALA intake ( 2. Non-smokers
- •3. Adults, able to independently express informed consent
- •4. Aged 30 to 70 years
- •5. Possible or probable Low-grade inflammation as defined below (one or more of the following criteria met):
- •5.1. Detection of High sensitivity C-reactive protein (HS-CRP) between 3 and 10 mg/L (in asymptomatic patients with no known recent infection)
- •5.2. Evaluation via Galmes Genetic Score
- •5.3. Evaluation via INFLA score (Moli-Sani project)
- •5.4. Clinical, laboratory, and nutritional criteria as per the following conditions (any one, or more, of the criteria 5.4.1-5.4.4, and any one, or more, of the criteria 5.4.5-5.4.7):
- •5.4.1. Evaluation via Kaluza J 2020 nutritional questionnaire
- •5.4.2. BIA-ACC criteria (4 points) and PPG stress flow
- •5.4.3. Presence of other inflammatory markers (specific morphological fibrinogen ESR markers)
- •5.4.4. Previous diagnosis made by a specialist
- •5.4.5. Persistent or relapsing clinical symptoms related to chronic inflammation
- •5.4.6. Presence of frequently associated conditions (metabolic syndrome, overweight)
- •5.4.7. History of chronic or phased NSAID intake (to be discontinued during the trial)
排除标准
- •1. Taking over-the-counter self-prescribed drugs or supplements
- •2. Using generic dietary formats, which are not reliable from a scientific point of view
- •3. Currently being treated with drugs (any type) or nutritional supplements (any type) or who are expected to start treatments during the study period
- •4. Clinical symptoms or instrumental laboratory parameters such as to suggest the presence of acute or subacute viral/bacterial infection or other inflammation
- •5. Require lipid-lowering or antithrombophilic therapy (patients with very high cardiovascular risk, patients with severe and/or unstable atheromasia, in any vascular district, patients with a history of angina, thromboembolism, TIA, heart infarction, stroke, etc.)
- •6. Menopausal, premenopausal and postmenopausal women under treatment or with active post-menopausal symptoms
- •7. Secondary metabolic diseases, endocrinopathies, and systemic diseases of any kind 8. Disabled or functionally limited patients
- •9. Severe depressive syndromes and/or other psychiatric diagnosis
- •10. Patients who for any reason cannot follow the periodic checks aimed to assess their diet and the adherence to the study
- •11. Previous bulimia/anorexia
- •12. Recent (within 3 months) strong decrease or increase in weight
- •13. Weight fluctuations greater than the sum of the analytical and pre-analytical physiological variability according to gender, age and weight
- •14. Weight trends on multiple measures constantly increasing or decreasing
- •15. BMI >30
- •16. Food restrictions due to food intolerances (unless these are attributable to LGI, with the exclusion of other causes, lactose, nickel, celiac disease, etc., intolerances) and vegan/vegetarian diets or for any other reason
研究者
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