ISRCTN12319920
Active, not recruiting
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 sites24 target enrollmentJune 1, 2020
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- ow-grade inflammation
- Sponsor
- Digitcal S.r.l.
- Enrollment
- 24
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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