Safety: Healthy Subjects Clinical Trial
— 15BSHEOfficial title:
A Randomized, Double-blind, Placebo Controlled Study to Evaluate Safety and Health Benefits of Basis™ Among Elderly Subjects.
| NCT number | NCT02678611 |
| Other study ID # | 15BSHE |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 1 |
| First received | February 3, 2016 |
| Last updated | July 28, 2016 |
| Start date | January 2016 |
| Verified date | July 2016 |
| Source | Elysium Health |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Canada: Health Canada |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 120 |
| Est. completion date | |
| Est. primary completion date | July 2016 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 60 Years to 80 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
| Country | Name | City | State |
|---|---|---|---|
| Canada | KGK Synergize Inc. | London | Ontario |
| Lead Sponsor | Collaborator |
|---|---|
| Elysium Health | KGK Synergize Inc. |
Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Expression Profile of Peripheral Blood Mononuclear Cells | 8 weeks | No | |
| Other | Pain Assessment | VAS Pain Scale | 8 weeks | No |
| Other | Endothelial Function | EndoPat | 8 weeks | No |
| Primary | Blood pressure | Assessment of blood pressure | 8 weeks | Yes |
| Primary | 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 | Yes |
| Primary | Heart Rate | Assessment of heart rate | 8 weeks | Yes |
| Secondary | Physiological Performance | 6 Minute Walk Test | 8 weeks | No |
| Secondary | Physiological Performance | 30 Second Chair Stand Test | 8 weeks | No |
| Secondary | Physiological Performance | Physical Activity Scale for the Elderly | 8 weeks | No |
| Secondary | Body Weight | 8 weeks | No | |
| Secondary | Blood Pressure | 8 weeks | No | |
| Secondary | Serum Glucose | 8 weeks | No | |
| Secondary | Lipid Profile | 8 weeks | No | |
| Secondary | Quality of Life and Sleep Quality | Health Assessment Questionnaire | 8 weeks | No |
| Secondary | Quality of Life and Sleep Quality | Older People's Quality of Life Questionnaires | 8 weeks | No |
| Secondary | Blood NAD+ | 8 weeks | No |