Low-grade inflammation Nutritional, Metabolic, Endocrine Chronic low-grade inflammation
Conditions
Interventions
Participants will be randomly assigned to receive either ALFALIFE™ supplements or an identical placebo control. Both arms will be asked to take 6 capsules orally each day (1 at breakfast, 2 at lunch,
the placebo contains edible oil and is presented in soft capsules that appear identical to ALFALIFE™. ALFALIFE™ contains cannabis sativa seed oil, extracted with mechanical process of cold pressing fr
Sponsors
Digitcal S.r.l.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with non-optimal ALA intake (<RDA of 0.5%) 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Diabetes and prediabetes risk measured by insulin-resistance and lipid profile levels from blood samples collected at baseline, 60, and 90 days 2. General health and medical conditions measured through full medical history and examination at baseline, 60, and 90 days 3. Adverse events and side effects assessed through full medical history and examination, medical records, and recording of all supplements and drugs taken by participants at baseline, 60, and 90 days 4. Heart rate and heart rate variability measured using ECG with RR interval recording at baseline and 30 days 5. Body composition measured using BIA-ACC dual-frequency bioimpedance device at baseline and 30 days 6. Participant quality of life measured using the sleep quality questionnaire (PSQI), and quality of life questionnaire (SF12) at 30 and 60 days 7. Dietary adherence assessed through the diet adherence questionnaire at 30 and 60 days 8. Physical activity assessed through the 7-day recall questionnaire and physical activity monitoring questionnaire (IPAQ) at 30 and 60 days 9. Participant tolerance and compliance assessed through the capsule tolerance/adherence/intake questionnaire at 30 and 60 days | — |
Countries
Italy
Contacts
Public ContactMaurizio Cipolla
Outcome results
None listed