Aging, HealthySAFE-AGENCT07442097
Safe-Age Study: A Safety and Tolerability Study of a Nutritional Supplement in Healthy Older Adults
A study testing Youniqor in people with Aging, Healthy, run by YOXLO B.V. at 1 site in India.
Trial summary
The goal of this clinical trial is to evaluate the safety and tolerability of the nutritional supplement Youniqor in healthy older adults. The main questions it aims to answer are: Is Youniqor safe and well tolerated when taken daily by healthy adults aged 60 to 80 years? Are there any adverse events or clinically… Read more about this study
- Who is it for?
- Ages 60 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging, Healthy
- What is being tested?
- Youniqor
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteIndia
- Study dates
- 12 Feb 2026to 31 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Body mass index (BMI) between 22.5 and 29.9 kg/m², inclusive.
- High-sensitivity C-reactive protein (hsCRP) levels between 0.7 and 5.0 mg/L, inclusive.
- Willingness to provide written informed consent.
- Willingness to comply with all study procedures and follow-up visits.
- Willingness to avoid major lifestyle changes, including new structured physical training or cognitive training targeting study endpoints, during the study period.
Who cannot join
- Presence of chronic, inflammatory, or cardiometabolic disease requiring daily medication.
- Uncontrolled diabetes mellitus (fasting blood glucose ≥126 mg/dL).
- Hypertension.
- Estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m².
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2× the upper limit of normal.
- White blood cell count <3500/mm³.
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- Ongoing or recent acute infection within 2 weeks prior to screening.
- Vaccination within 4 weeks prior to screening.
- Known allergy or intolerance to N-acetyl-L-cysteine (NAC) or glycine.
- Participation in another clinical trial within 90 days prior to screening.
- Current or recent use of systemic corticosteroids, immunosuppressants, or chronic pain medications.
- neurodegenerative, neurological, or major psychiatric disorders.
- History of alcohol or drug abuse based on medical history, physical examination, or investigator judgment.
- Current smokers.
- Any other condition which, in the opinion of the investigator, may interfere with study participation or safety.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
India1 site, 1 recruiting
- Recruiting
Vedic Lifesciences Pvt. Ltd.
Pune, Maharashtra, 411045
Kishori Pasthe, Dr, +91 82917 57065, clinicaltrials@vediclifesciences.com
About this study
Official title: An Open-Label, Single-Arm Study to Assess the Safety of Youniqor Consumption in Healthy Adults
The goal of this clinical trial is to evaluate the safety and tolerability of the nutritional supplement Youniqor in healthy older adults. The main questions it aims to answer are:
Is Youniqor safe and well tolerated when taken daily by healthy adults aged 60 to 80 years? Are there any adverse events or clinically relevant changes in vital signs or laboratory parameters during the study period?
Participants will:
Take Youniqor daily for 8 weeks Attend scheduled study visits for safety assessments, including vital signs, blood and urine tests, and electrocardiograms Report any adverse events during the study period
Read the detailed description
This is an open-label, single-arm interventional study designed to assess the safety and tolerability of the nutritional supplement Youniqor in healthy older adults. The study will enroll men and women aged 60 to 80 years who meet predefined eligibility criteria and provide written informed consent.
Participants will receive daily oral supplementation with Youniqor for a period of 8 weeks. Safety will be monitored throughout the study through the assessment of adverse events, vital signs, clinical laboratory parameters, and electrocardiograms at predefined time points.
The study is conducted at clinical research sites in India under the oversight of an independent ethics committee and in accordance with applicable regulatory and ethical guidelines. The results of this study are intended to support the characterization of the safety profile of Youniqor in healthy older adults.
- Conditions
- Aging, Healthy
- Being tested
- Youniqor
- Keywords
- Aging, Healthy Volunteers, nutritional supplement, safety study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YouniqorDietary supplement
Youniqor is an orally administered nutritional supplement. Participants will take the supplement twice daily for 8 weeks as part of this study.
| Study group | Role | What they receive |
|---|---|---|
| Youniqor Supplement | Experimental | Participants in this arm will receive the nutritional supplement Youniqor, administered orally twice daily for a period of 8 weeks. All participants will follow the same intervention and undergo scheduled safety assessments throughout the study. Receives: Dietary Supplement: Youniqor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events
Assessment of the incidence, nature, and severity of adverse events and serious adverse events occurring during the study period.
Measured: 8 weeks
Tolerability will be assessed
Tolerability will be assessed based on number of subjects drop out due to treatment related adverse events
Measured: 8 weeks
Secondary outcomes (6)
Change in blood pressure (systolic and diastolic)
Change from baseline of systolic and diastolic blood pressure
Measured: 8 weeks
Clinically significant ECG abnormalities
Number of participants with clinically significant abnormalities on 12-lead resting ECG, as determined by Investigator/medical monitor review (including heart rate/rhythm and interval abnormalities).
Measured: 8 weeks
Change in liver function
Change of liver function as measured by serum alkaline phosphatase, AST, and ALT in IU/L compared with the baseline
Measured: 8 weeks
Change in QTc interval
Change in QTc interval derived from 12-lead resting ECG compared to baseline
Measured: 8 weeks
Change in renal function
Change of renal function as measured by serum albumin in g/dL compared with the baseline
Measured: 8 weeks
Change in complete blood count (CBC)
Change in complete blood count as compared to baseline
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2026
- Study start12 Feb 2026 (estimated)
- Primary completion10 Jul 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aging, HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- YOXLO B.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Vedic Lifesciences Pvt. Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07442097
- Sponsor's protocol ID
- SAFE-AGE
- Acronym
- SAFE-AGE
- Status last verified
- Feb 2026
- First submitted
- 8 Feb 2026
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Single-Arm Study to Assess the Safety of Youniqor Consumption in Healthy Adults
- ClinicalTrials.gov ID
- NCT07442097
- Acronym / sponsor ID
- SAFE-AGE / SAFE-AGE
- Conditions
- Aging, Healthy
- Keywords
- Aging, Healthy Volunteers, nutritional supplement, safety study
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- YOXLO B.V.Industry (pharma, biotech, devices)
- Collaborators
- Vedic Lifesciences Pvt. Ltd.
- Study start
- 12 Feb 2026 (estimated)
- Primary completion
- 10 Jul 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 2 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to evaluate the safety and tolerability of the nutritional supplement Youniqor in healthy older adults. The main questions it aims to answer are:
Is Youniqor safe and well tolerated when taken daily by healthy adults aged 60 to 80 years? Are there any adverse events or clinically relevant changes in vital signs or laboratory parameters during the study period?
Participants will:
Take Youniqor daily for 8 weeks Attend scheduled study visits for safety assessments, including vital signs, blood and urine tests, and electrocardiograms Report any adverse events during the study period
Detailed description
This is an open-label, single-arm interventional study designed to assess the safety and tolerability of the nutritional supplement Youniqor in healthy older adults. The study will enroll men and women aged 60 to 80 years who meet predefined eligibility criteria and provide written informed consent.
Participants will receive daily oral supplementation with Youniqor for a period of 8 weeks. Safety will be monitored throughout the study through the assessment of adverse events, vital signs, clinical laboratory parameters, and electrocardiograms at predefined time points.
The study is conducted at clinical research sites in India under the oversight of an independent ethics committee and in accordance with applicable regulatory and ethical guidelines. The results of this study are intended to support the characterization of the safety profile of Youniqor in healthy older adults.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Youniqor Supplement | Experimental | Dietary Supplement: YouniqorParticipants in this arm will receive the nutritional supplement Youniqor, administered orally twice daily for a period of 8 weeks. All participants will follow the same intervention and undergo scheduled safety assessments throughout the study. |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Body mass index (BMI) between 22.5 and 29.9 kg/m², inclusive.
- High-sensitivity C-reactive protein (hsCRP) levels between 0.7 and 5.0 mg/L, inclusive.
- Willingness to provide written informed consent.
- Willingness to comply with all study procedures and follow-up visits.
- Willingness to avoid major lifestyle changes, including new structured physical training or cognitive training targeting study endpoints, during the study period.
Key exclusion criteria (15 listed)
- Presence of chronic, inflammatory, or cardiometabolic disease requiring daily medication.
- Uncontrolled diabetes mellitus (fasting blood glucose ≥126 mg/dL).
- Hypertension.
- Estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m².
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2× the upper limit of normal.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| YouniqorYouniqor is an orally administered nutritional supplement. Participants will take the supplement twice daily for 8 weeks as part of this study. | Dietary supplement | Youniqor Supplement |
Primary outcome
Incidence of Adverse Events
Time frame: 8 weeks
Assessment of the incidence, nature, and severity of adverse events and serious adverse events occurring during the study period.
Tolerability will be assessed
Time frame: 8 weeks
Tolerability will be assessed based on number of subjects drop out due to treatment related adverse events
6 secondary outcomes
Change in blood pressure (systolic and diastolic)
Time frame: 8 weeks
Clinically significant ECG abnormalities
Time frame: 8 weeks
Change in liver function
Time frame: 8 weeks
Change in QTc interval
Time frame: 8 weeks
Change in renal function
Time frame: 8 weeks
Change in complete blood count (CBC)
Time frame: 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Youniqor in people with Aging, Healthy, run by YOXLO B.V. at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stef F Verlinden, MD (+31618516018, stef@yoxlo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse Events (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2026.