Effects of Indena's Virtiva® Plus Ginkgo Biloba Extract on Stress, and Cognitive Performance

Launched by APPLIED SCIENCE & PERFORMANCE INSTITUTE · Aug 31, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a product called Virtiva® Plus, which contains Ginkgo Biloba extract, on stress and how well people think and remember. The trial will last 5 weeks and will involve participants who are feeling more stressed than usual. Researchers want to see if taking this supplement in either a low dose or a higher dose can help improve mood and cognitive performance. The study will include up to 29 people aged 50 to 70 who meet specific health criteria. Participants will need to stop taking any other cognitive enhancement supplements a week before the study starts.

If you choose to participate, you will be randomly assigned to one of two groups that will receive either a low dose (240 mg) or a high dose (480 mg) of Virtiva® Plus, taken twice a day. During the study, you will be asked to maintain your usual diet and attend scheduled visits for assessments. It’s important to note that certain health conditions, like heart disease or neurological disorders, may prevent you from being eligible for this trial. The goal is to find out if the supplement can help reduce stress and improve thinking skills while monitoring for any side effects.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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