Status:
COMPLETED
Effects of Indena's Virtiva® Plus Ginkgo Biloba Extract on Stress, and Cognitive Performance
Lead Sponsor:
Applied Science & Performance Institute
Conditions:
Stress
Mood
Eligibility:
All Genders
50-70 years
Phase:
NA
Brief Summary
This is a randomized, double-blind, 5-week intervention clinical study that aims to investigate the dose-dependent effects of Virtiva® Plus on stress, and cognitive performance in participants experie...
Detailed Description
Enrollment (Week -4 to Week -3): After obtaining written informed consent participants will undergo screening to ensure they are free of cardiovascular-, neurological-, hepatic-, renal-, metabolic dis...
Eligibility Criteria
Inclusion
- Male or female
- Aged 50 to 70 years (both limits inclusive)
- Body mass index (BMI) value of 18.5-29.99 kg/m2
- Willing and able to give written informed consent
- Able to read, understand, sign and date the informed consent document (English only)
- Able and willing to comply with the schedule visit(s) and study requirements.
- Willing to consume the investigational study product 2 times per day for 5 weeks.
- Willing to maintain a habitual diet and avoid changes during the study period (for example, intermittent fasting, ketogenic diet, Atkins diet, meatless diet, etc.).
- Willing to cease from consuming cognitive enhancement supplements 7 days prior to and after the study commencement, until the end of the study.
Exclusion
- Developmental disability or cognitive impairment that would preclude adequate comprehension of the informed consent form and/or ability to follow study subject requirements and/or record the necessary study measurements.
- History of cardiovascular disease (i.e., myocardial infarction, hypertension, hypercholesterolemia, peripheral vascular disease, other)
- History of neurological disorders (Parkinson's, Amyotrophic lateral sclerosis, epilepsy, spinal cord injury resulting in inability to use upper extremities, other)
- History of gastrointestinal disorders that could lead to uncertain absorption of the study supplements, (i.e., inflammatory bowel disease, ulcerative colitis, Crohn's disease, colostomy, or eating disorder)
- History of kidney or liver disease
- History of metabolic disorders (diabetes, metabolic syndrome, other)
- History or current malignancy
- Receiving chemotherapy agents or radiation treatments
- Diagnosis of a terminal illness
- Pregnancy or has breast fed within 3 months prior to enrollment
- Use of prescription medications that impact digestion (i.e., proton pump inhibitor medications, other)
- History or current alcohol or drug abuse
- Has significant concurrent illnesses (controlled or uncontrolled), such as lupus, hepatitis B/C, HIV, serious mental health illness such as dementia or schizophrenia; psychiatric hospitalization in the past two years, or other, which in the opinion of the investigator, such condition might be aggravated as a result of treatment
- The investigator feels that for any reason the subject is not eligible to participate in the study
Key Trial Info
Start Date :
January 10 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 4 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06583941
Start Date
January 10 2025
End Date
April 4 2025
Last Update
September 16 2025
Active Locations (1)
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1
The Applied Science and Performance Institute
Tampa, Florida, United States, 33634