Complex dietary supplement (cocktail) for healthy longevity
| ISRCTN | ISRCTN85957759 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN85957759 |
- Submission date
- 31/01/2025
- Registration date
- 04/02/2025
- Last edited
- 05/02/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
This research project investigates a natural supplement blend, including prebiotics, autophagy stimulators, senolytic activators, and natural probiotics found in vegetables and fruits. The study aims to explore the effects of this supplement, known as CoLoSaN, on biomarkers that assess healthy longevity in medically healthy individuals. By examining these effects, the study seeks to provide insights into how such a supplement can contribute to a longer, healthier life.
Who can participate?
Healthy adult volunteers
What does the study involve?
The present clinical study involves the oral administration of five nutritional supplements: organic boron, calcium butyrate, iron chelators (curcumin and epigallocatechin), autophagy stimulators and senolytic activators (spermidine, glutamine, fisetin, and quercetin), and a probiotic complex (Lactobacillus plantarum, Streptococcus thermophilus, Bifidobacterium animalis, B. adolescentis, B. longum, Bacillus subtilis, and Bacillus coagulans). Each supplement is taken once daily, either after breakfast or lunch, for 60 days. Participation in this study is entirely voluntary, with an equal gender ratio among participants. This single-center study is conducted at the Bioboron Institute Craiova-Podari. Blood tests are collected at the beginning and end of the study to assess the effects of the supplements.
What are the possible benefits and risks of participants?
The immediate effect on patients is beneficial in that inflammatory and lipid markers are expected to decrease significantly. In the long term, the quality of life of the subjects involved in the study is expected to improve significantly.
The supplements have no known adverse effects. All the ingredients in the supplement cocktail are natural or identically natural, and each has been through toxicity testing showing that long-term supplementation has posed no health risks.
Where is the study run from?
The Bioboron Institute Craiova -Podari
When is the study starting and how long is it expected to run for?
January 2025 to March 2025
Who is funding the study?
1. The Bioboron Institute
2. The University of Medicine and Pharmacy Craiova
Who is the main contact?
Prof Dr Romulus Ion Scorei, romulus.scorei@naturalresearch.ro, romulus_ion@yahoo.com
Contact information
Public, Scientific, Principal Investigator
Bulevardul Decebal 73C, Decebal Residence, bloc B, ap.8, et 2
Craiova
200774
Romania
 ORCID ID |
0000-0001-7157-4288 |
|---|---|
| Phone | +40744538207 |
| romulus.scorei@naturalresearch.ro |
Study information
| Study design | Single-centre randomized controlled pilot study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Home |
| Study type | Quality of life |
| Participant information sheet | 46779_PIS_08Dec2024.pdf |
| Scientific title | Microbiota-accessible cocktail for healthy longevity |
| Study acronym | CoLoSaN |
| Study objectives | This "Complex Dietary Supplement (cocktail) for Healthy Longevity" (CoLoSan) cocktail targets biomarkers proven to be involved in the prognosis of a long and healthy life. |
| Ethics approval(s) |
Approved 10/01/2025, Bioethic Board of Natural Research, Bioboron Research Institute in Craiova (Dunarii street No,31, Podari, 207465, Romania; +40351 433 500 int. 4031; cosmin.cristea@umfcv.ro), ref: No.7/10.01.2025 |
| Health condition(s) or problem(s) studied | Healthy adults |
| Intervention | 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. Procedures and Protocol This clinical trial is single-center, randomized and controlled. The trial site is the Bioboron Institute Craiova -Podari. Blood tests will be collected once at the beginning of the study and a second time at the end of the study (after 60 days). |
| Intervention type | Supplement |
| Primary outcome measure | 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 spectrophotometric method; reference values: 55-100 mg/dL for women and 50-100 mg/dL for men 2.4.2. Low-density lipoprotein-C [LDL-C]: calculated using the Friedewald formula: LDL-cholesterol = Total Cholesterol – (HDL-cholesterol + VLDL-cholesterol); reference values: 60-100 mg/dL 2.4.3. Total Cholesterol (TC): a spectrophotometric method dedicated to the quantitation of cholesterol in serum or plasma; reference values: 70-240 mg/dL 2.4.4. Triglycerides [TGs]: a spectrophotometric method dedicated to the quantitation of triglycerides in serum or plasma; reference values: <150 mg/dL 2.5.1. Liver enzymes (gamma-glutamyl transferase [GGT], alkaline phosphatase [ALP], and lactate dehydrogenase [LDH]): 2.5.2. Gamma-glutamyl transferase (GGT) - a spectrophotometric method dedicated to the quantitation of GGT activity in serum or plasma: reference values: 0-38 U/L for women 0-55 U/L for men 2.5.3. Alkaline Phosphatase (AlP) – a spectrophotometric method dedicated to the quantitation of AlkP activity in serum or plasma: Reference values: 46-122 U/L for women and 50-116 U/L for men; 2.5.4. Lactate dehydrogenase (LDH) - a spectrophotometric UV method dedicated to the quantitation of LDH activity in serum or plasma; reference values: 125-220 U/L; 2.6. Glucose: a spectrophotometric method dedicated to the quantitation of glucose in biological fluids; reference values: 70-110 mg/dL g) total iron and total iron-binding capacity (TIBC) measured using blood tests at baseline and 60 days: 2.7. Iron - a spectrophotometric method dedicated to the quantitation of iron in serum or plasma; reference values: 50-170 µg/dL for women and 65-175 µg/dL for men 2.8. Transferrin - an immunoturbidimetric method dedicated to the quantitation of transferrin in serum or plasma; reference values: 180-382 mg/dL for women and 174-364 mg/dL for men 2.9. Ferritin – a chemiluminescence method for the quantitative determination of ferritin in human serum and plasma; reference values: 13-150 ng/mL for women; 30-400 ng/mL for men 2.10. Total Iron Binding Capacity of Transferrin (TIBC) was calculated as follows: TIBC (µmoles/L) = Transferrin (g/L) x 25.2 |
| Secondary outcome measures | 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 |
| Overall study start date | 01/01/2025 |
| Completion date | 05/03/2025 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 40 Years |
| Upper age limit | 80 Years |
| Sex | Both |
| Target number of participants | 13 |
| Total final enrolment | 12 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 05/01/2025 |
| Date of final enrolment | 31/01/2025 |
Locations
Countries of recruitment
- Romania
Study participating centre
Craiova
200349
Romania
Sponsor information
Research organisation
Dunarii Street No.31B
Podari
207465
Romania
| Phone | +40 740 115 137 |
|---|---|
| office@naturalresearch.ro | |
| Website | https://www.naturalresearch.ro/ |
University/education
Petru Rares, No.2
Craiova
200349
Romania
| Phone | +40351443500/int.4031 |
|---|---|
| cosmin.criste@umfcv.ro | |
| Website | https://umfcv.ro/en |
"ROR" |
https://ror.org/031d5vw30 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 07/10/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Published as a supplement to the results publication |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal. |
| IPD sharing plan | The datasets generated during the current study will be stored in a non-publicly available repository at https:// www.naturalreseach.ro/ and will be published as a supplement to the publication of the results. This proposal has been reviewed and approved by the Institutional Ethics Committee of the University of Medicine and Pharmacy of Craiova, Romania, to protect all participants in a research study. This trial is in accordance with the 1975 Declaration of Helsinki, which was revised in 2008. This trial has also been reviewed by its sponsors, namely S.C. Natural Research S.R.L. Craiova and the University of Medicine and Pharmacy of Craiova, Dolj, Romania |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Other files | 04/02/2025 | No | No | ||
| Participant information sheet | 08/12/2024 | 04/02/2025 | No | Yes |
Additional files
Editorial Notes
05/02/2025: Justification was given for the study dates stating that the recruitment of participants and the request for ethical approval both started in December 2024, but due to the seasonal holidays, the ethical approval was issued on January 10th, 2025. Despite institutions resuming work on January 8th, 2025, the study was considered to have officially started on January 5th, 2025, when patient consent was received.
04/02/2025: Study's existence confirmed by the Bioethic Board of Natural Research, Bioboron Research Institute in Craiova.
