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

Launched by ELYSIUM HEALTH · Feb 9, 2016

Keywords

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Gender

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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