Healthy adults Other
Conditions
Interventions
The present clinical study involves the oral administration of the following 5 nutritional supplements:
1. Organic boron (1 capsule per day)
2. Calcium butyrate (1 capsule per day)
3. Iron chelators (curcumin and epigallocatechin) (1 capsule per day)
4. Autophagy stimulators and the senolytic activators (spermidine, glutamine, fisetin and quercetin) (1 capsule per day)
5. Probiotic Complex (Lactobacillus plantarum, Streptococcus thermophilus, Bifidobacterium animalis, B.adolescentis, B.longum, Bacillus subtilis and Bacillus cuagulans). (1 capsule per day)
The supplements will be taken during the same day, after breakfast and/or lunch (once or twice) for 60 days.
Participation in this research is entirely voluntary with a 1:1 gender ratio selection. Pr
Sponsors
Natural Research Bioboron Research Institute
University of Medicine and Pharmacy of Craiova
Eligibility
Sex/Gender
All
Age
40 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Clinically healthy subjects 2. Male or female patients 3. Age >40 years 4. BMI range 17-27 kg/m2 (normal, overweight, but not obese) 5. Normal or minor hypertension <140/80-90 mmHg 6. Informed consent was obtained at screening
Exclusion criteria
Exclusion criteria: 1. Refusal to participate or to sign informed consent 2. Proven co-infection with Clostridium difficile 3. Other infections except for respiratory tract 4. Known IBD or other diseases that may significantly influence MG
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Stool quality and significant general symptoms associated with intestinal dysmotility measured using questionnaires [is this a named tool, or bespoke?] at [timepoint] Stool quality and significant general symptoms associated with intestinal dysmotility measured using (VAS-IBS) self-estimation on gastrointestinal symptoms - questionnaire, at 30 days and 60 days 2. Levels of uric acid, high sensitivity C-reactive protein (hs-CRP), creatinine, lipid profiles (high-density lipoprotein-C [HDL-C], low-density lipoprotein-C [LDL-C], total cholesterol [TC], triglycerides [TGs]), liver enzymes (gamma-glutamyl transferase [GGT], alkaline phosphatase [ALP], and lactate dehydrogenase [LDH]), glucose, total iron and total iron-binding capacity (TIBC) measured using blood tests at baseline and 60 days 2. Biochemical parameters were measured using standardized methods on an Alinity c analyzer and, for ferritin, on a Cobas 6000 platform: 2.1. Levels of uric acid: a spectrophotometric method dedicated to the quantitative detection of uric acid in clinical specimens; reference values: 2.5-6.2 mg/dL for women and 3.7-7.7 mg/dL for men. 2.2. High sensitivity C-reactive protein (hs-CRP): CRP Vario Reagent kit – quantitative immunoturbidimetric determination of C-reactive protein with variable assay ranges: CRP48 and CRP16 (high sensitivity CRP method); reference values: 0-5 mg/L for CRP < 1mg/L for hs-CRP 2.3. Creatinine: a spectrophotometric method dedicated to the quantitation of creatinine in clinical specimens (serum, plasma, urine); reference values: 0.55-1.02 mg/dL for women 0.73-1.18 mg/dL for men 2.4 Lipid profiles (high-density lipoprotein-C [HDL-C], low-density lipoprotein-C [LDL-C], total cholesterol [TC], triglycerides [TGs]): 2.4.1. High-density lipoprotein-C [HDL-C]: Ultra HDL assay - a homogeneous method for directly measuring HDL- cholesterol in serum or plasma without the need for off-line pretreatment or centrifugation steps accomplished using finally a spectroph | — |
Secondary
| Measure | Time frame |
|---|---|
| The following secondary outcome measures are assessed at 60 days: 1. Adverse events, defined using the Romanian Medicines Agency Guidelines, measured using data collected from the patient card for spontaneous reporting of adverse drug reactions 2. Quality of life measured using the World Health Organization Quality of Life (WHOQOL) brief short-form assessment | — |
Countries
Romania
Contacts
Public ContactIon Romulus Scorei
Outcome results
None listed