A Study to Evaluate Safety and Health Benefits of Basis™ Among Elderly Subjects. (15BSHE)

Elysium Health

Status and phase

Completed

Phase 1

Conditions

Safety: Healthy Subjects

Treatments

Dietary Supplement: Basis 500

Dietary Supplement: Placebo

Dietary Supplement: Basis 250

Study type

Interventional

Funder types

Industry

Identifiers

NCT02678611

15BSHE

Details and patient eligibility

About

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.

Enrollment

120 patients

Sex

All

Ages

60 to 80 years old

Volunteers

Accepts Healthy Volunteers

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