Last updated: November 10, 2022
Sponsor: The Center for Applied Health Sciences, LLC
Overall Status: Completed
Phase
N/A
Condition
Aging
Treatment
N/AClinical Study ID
NCT04276948
CS-01-2020
Ages 40-60 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Provide voluntary signed and dated informed consent.
- Be in good health as determined by medical history, physical, and routine bloodchemistries.
- Age between the ages of 40 and 60 (inclusive).
- Body Mass Index (BMI) of 18.5-34.9 kg/m2 (normal to Class I obesity).
- Normotensive (supine, resting systolic blood pressure <140 mm Hg and diastolic bloodpressure < 90 mm Hg. If the first measurement is slightly elevated above these limits,the subject will be given a brief (5 minute) rest period, and two more measurementswill be taken. The average of all three measurements will be used to determineeligibility.
- Normal supine, resting heart rate (<90 per minute).
- Willing to duplicate their previous 24-hour diet, and fast for 10 hours prior each ofthe treatments.
Exclusion
Exclusion Criteria:
- History of uncontrolled diabetes.
- Regular use/consumption (i.e. at least 5 days/week) of resveratrol, quercetin,pterostilbene coQ10, grapefruit, nicotinamide riboside, probiotics, prebiotic fiber,green tea, niacin (vitamin B3), multivitamin/multimineral or products meant to promote "healthy aging" or "anti-aging" or "longevity" products in the 2 weeks prior toscreening as well as throughout the study.
- Clinically significant abnormal blood work at screening.
- Consumption of > 2 alcoholic drinks per day.
- History of malignancy in the previous 5 years except for non-melanoma skin cancer (basal cell cancer or squamous cell cancer of the skin).
- Other known gastrointestinal or metabolic diseases that might impact nutrientabsorption or metabolism, e.g. short bowel syndrome, diarrheal illnesses, history ofcolon resection, gastro paresis, Inborn-Errors-of-Metabolism (such as PKU).
- Chronic inflammatory condition/disease or unstable medical condition (e.g. rheumatoidarthritis, Crohn's disease, ulcerative colitis, Lupus, hepatitis, HIV/AIDS, etc.).
- Known sensitivity to any ingredient in the test formulations as listed in theCertificates-of-Analysis.
- Currently participating in another research study with an investigational product orhave been in another research study in the past 30 days.
- History of drug or alcohol addiction or abuse within 1 year prior to screening.
- Treatment with any known enzyme-altering drugs such as barbiturates, glucocorticoids,macrolides, antidepressants, neuroleptics, imidazoles, or fluoroquinolones within 30days prior to screening.
- Subjects who (for whatever reason) have been on a self-restricted diet, controlleddiet or special therapeutic diet, or who have had substantial changes in eating habitswithin 30 days prior to screening.
- Donation of blood within 30 days or plasma within 7 days, prior to screening.
- History or presence of clinically significant diseases or conditions (e.g.,cardiovascular, pulmonary, respiratory, hepatic, renal, hematological,gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric)which, in the opinion of the medical staff, could confound the primary endpoints orplace the subject at increased risk of harm if they were to participate.
Study Design
Total Participants: 45
Study Start date:
June 08, 2020
Estimated Completion Date:
May 30, 2021
Connect with a study center
The Center for Applied Health Sciences
Canfield, Ohio 44406
United StatesSite Not Available

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