Clinical trial NCT02678611: A Study to Evaluate Safety and Health Benefits of Basis™ Among Elderly Subjects.
Official title: A Randomized, Double-blind, Placebo Controlled Study to Evaluate Safety and Health Benefits of Basis™ Among Elderly Subjects.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Safety: Healthy Subjects
Keywords: Healthy participants
Dietary supplement
Safety
Tolerability
Older Adults
Basis
Nicotinamide riboside
Pterostilbene
Lead sponsor: Elysium Health
Sponsor class: INDUSTRY
Collaborators: name: KGK Science Inc.
First posted: 2016-02-10
Enrollment: 120
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.


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

Primary outcomes:
measure: Blood pressure
timeFrame: 8 weeks
measure: Safety Blood Parameters
timeFrame: 8 weeks
measure: Heart Rate
timeFrame: 8 weeks
Secondary outcomes:
measure: Physiological Performance
timeFrame: 8 weeks
measure: Physiological Performance
timeFrame: 8 weeks
measure: Physiological Performance
timeFrame: 8 weeks
measure: Body Weight
timeFrame: 8 weeks
measure: Blood Pressure
timeFrame: 8 weeks
measure: Serum Glucose
timeFrame: 8 weeks
measure: Lipid Profile
timeFrame: 8 weeks
measure: Quality of Life and Sleep Quality
timeFrame: 8 weeks
measure: Quality of Life and Sleep Quality
timeFrame: 8 weeks
measure: Blood NAD+
timeFrame: 8 weeks
Other outcomes:
measure: Expression Profile of Peripheral Blood Mononuclear Cells
timeFrame: 8 weeks
measure: Pain Assessment
timeFrame: 8 weeks
measure: Endothelial Function
timeFrame: 8 weeks
Locations:
city: London
country: Canada
facility: KGK Synergize Inc.
state: Ontario
Study officials:
affiliation: KGK Science Inc.
name: Tetyana Pelipyagina, MD
role: PRINCIPAL_INVESTIGATOR
References: