The effect of ALFALIFE™ in reducing low-grade inflammatio

Not Applicable

• Conditions: ow-grade inflammation; Nutritional, Metabolic, Endocrine; Chronic low-grade inflammation

• Registration Number: ISRCTN12319920
• Lead Sponsor: Digitcal S.r.l.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-06-01
• Last Update Posted: 15 June 2020
• Study Completion: 2020-10-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 24

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
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)

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
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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Improvement in low-grade inflammation measured by cholesterol total, LDLc, HDLc triglycerides, Lp (a), glycemia, glycated hemoglobin, HOMA-IR, HOMA-B, leptin, ghrelin, VCAM, ICAM, endothelin, homocysteine, fibrinogen, uricemia, PCR-HS, cytokines (13), total lymphocytes, ferritin, GOT, GPT, CPK, and creatinine levels from blood samples collected at baseline, 60, and 90 days.<br>