A Study to Evaluate Safety and Health Benefits of Basis™ Among Elderly Subjects.

Study Overview
=================
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.

Official Title
-----------------
A Randomized, Double-blind, Placebo Controlled Study to Evaluate Safety and Health Benefits of Basis™ Among Elderly Subjects.

Conditions
-----------------
Safety: Healthy Subjects

Intervention / Treatment
-----------------
* Dietary Supplement: Basis 250
* Dietary Supplement: Basis 500
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 60 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Basis 250<br> | Dietary Supplement: Basis 250<br> <br> |
| Experimental: Basis 500<br> | Dietary Supplement: Basis 500<br> <br> |
| Placebo Comparator: Placebo<br> | Dietary Supplement: Placebo<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure | Assessment of blood pressure | 8 weeks | 
| Safety Blood Parameters | Assessment of safety blood parameters: CBC, electrolytes (Na, K, Cl), kidney function (creatinine), liver function (AST, ALT, GGT and bilirubin) | 8 weeks | 
| Heart Rate | Assessment of heart rate | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physiological Performance | 6 Minute Walk Test | 8 weeks | 
| Physiological Performance | 30 Second Chair Stand Test | 8 weeks | 
| Physiological Performance | Physical Activity Scale for the Elderly | 8 weeks | 
| Body Weight |  | 8 weeks | 
| Blood Pressure |  | 8 weeks | 
| Serum Glucose |  | 8 weeks | 
| Lipid Profile |  | 8 weeks | 
| Quality of Life and Sleep Quality | Health Assessment Questionnaire | 8 weeks | 
| Quality of Life and Sleep Quality | Older People's Quality of Life Questionnaires | 8 weeks | 
| Blood NAD+ |  | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Healthy participants, Dietary supplement, Safety, Tolerability, Older Adults, Basis, Nicotinamide riboside, Pterostilbene