Complex dietary supplement (cocktail) for healthy longevity
| ISRCTN | ISRCTN85957759 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN85957759 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | Nil known |
| Sponsors | Natural Research Bioboron Research Institute, University of Medicine and Pharmacy of Craiova |
| Funder | Natural Research Ltd |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Single-centre randomized controlled pilot study |
| Secondary study design | Randomised controlled trial |
| 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(s) |
1. Stool quality and significant general symptoms associated with intestinal dysmotility measured using questionnaires [is this a named tool, or bespoke?] at [timepoint] |
| Key secondary outcome measure(s) |
The following secondary outcome measures are assessed at 60 days: |
| 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 | All |
| Target sample size at registration | 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
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Published as a supplement to the results publication |
| 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 | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Additional files
- 46779_PIS_08Dec2024.pdf
- Participant information sheet
- 46779_Romanian_WHOQOL-BREF.pdf
- Other 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.
