Safety: Healthy Subjects
Conditions
Keywords
Healthy participants, Dietary supplement, Safety, Tolerability, Older Adults, Basis, Nicotinamide riboside, Pterostilbene
Brief summary
This study will investigate the safety, tolerability and potential health benefits of the dietary supplement, Basis. There will be two doses of Basis compared to a placebo. One third of subjects will receive the low dose Basis, one third will receive the higher dose Basis and one third will receive placebo.
Interventions
DIETARY_SUPPLEMENTBasis 250
DIETARY_SUPPLEMENTBasis 500
DIETARY_SUPPLEMENTPlacebo
Sponsors
KGK Science Inc.
Elysium Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Males or females 60 to 80 (inclusive) years of age * Body Mass Index (BMI) must be 18 to 35 kg/ m2 (±1 kg/m2) * •Be able to make scheduled office visits 4 times during the study * Willing to follow the instructions and complete multiple study questionnaires and assessments * Agrees to avoid taking Vitamin B3 (Niacin, Nicotinic acid or niacinamide) supplements or multivitamins 14 days prior to randomization and for the duration of the study period * Healthy otherwise as determined by laboratory results and medical history * Has given voluntary, written, informed consent to participate in the study
Exclusion criteria
* History of any significant chronic disease or any clinically active illness within 3 months of study entry, including any history of renal or liver impairment, any endocrine, inflammatory, cardiovascular, gastro-intestinal, neurological, psychiatric, neoplastic or metabolic disease. Clinical significance of disease will be assessed by the Qualified Investigator and eligibility determined. * Significant or untreated medical disorders including recent myocardial ischemia or infarction, unstable angina, uncontrolled hypertension, AIDS, malignancy, epilepsy, and recent cerebrovascular disease * Subjects with or who have recently experienced a traumatic injury, infections or undergone surgery * Subjects with history of pellagra or niacin deficiency * Taking lipid lowering drugs * Use of natural health products containing Nicotinamide riboside within 14 days prior to randomization and during the course of the study * History of or current diagnosis of any cancer (except for successfully treated basal cell carcinoma) diagnosed less than 5 years prior to screening. Volunteers with cancer in full remission more than 5 years after diagnosis are acceptable * Has participated in any clinical trial with an investigational medicinal product within the past three months prior to the first dose in the current study * Unstable medical conditions * Alcohol use \>2 standard alcoholic drinks per day * History of alcoholism or drug abuse within 1 year prior to screening * History of significant allergies * Allergy or sensitivity to any of the investigational product ingredients * Use of medicinal marijuana * Clinically significant abnormal laboratory results at screening * Individuals who are cognitively impaired and/or who are unable to give informed consent * Any other condition which in the Investigator's opinion may adversely affect the participant's ability to complete the study or its measures or which may pose significant risk to the participant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety Blood Parameters | 8 weeks | Assessment of safety blood parameters: CBC, electrolytes (Na, K, Cl), kidney function (creatinine), liver function (AST, ALT, GGT and bilirubin) |
| Heart Rate | 8 weeks | Assessment of heart rate |
| Blood pressure | 8 weeks | Assessment of blood pressure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood Pressure | 8 weeks | — |
| Lipid Profile | 8 weeks | — |
| Quality of Life and Sleep Quality | 8 weeks | Health Assessment Questionnaire |
| Blood NAD+ | 8 weeks | — |
| Serum Glucose | 8 weeks | — |
| Physiological Performance | 8 weeks | 6 Minute Walk Test |
| Body Weight | 8 weeks | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Expression Profile of Peripheral Blood Mononuclear Cells | 8 weeks | — |
| Endothelial Function | 8 weeks | EndoPat |
| Pain Assessment | 8 weeks | VAS Pain Scale |
Countries
Canada
Outcome results
None listed