History of Changes for Study: NCT02678611

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

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Study Record Versions

Version	Submitted Date	Changes
1	February 9, 2016	None (earliest Version on record)
2	July 28, 2016	Recruitment Status, Study Status, Contacts/Locations and Study Design
	Results Submission Events
March 14, 2018		Returned after QC review: October 12, 2018

Comparison Format:

Merged
Side-by-Side

Study Identification


Unique Protocol ID:	15BSHE
Brief Title:	A Study to Evaluate Safety and Health Benefits of Basis™ Among Elderly Subjects. (15BSHE)
Official Title:	A Randomized, Double-blind, Placebo Controlled Study to Evaluate Safety and Health Benefits of Basis™ Among Elderly Subjects.
Secondary IDs:

Study Status


Record Verification:	February 2016
Overall Status:	Recruiting
Study Start:	January 2016
Primary Completion:	June 2016 [Anticipated]
Study Completion:

First Submitted:	February 3, 2016
First Submitted that Met QC Criteria:	February 9, 2016
First Posted:	February 10, 2016 [Estimate]

Last Update Submitted that Met QC Criteria:	February 9, 2016
Last Update Posted:	February 10, 2016 [Estimate]

Sponsor/Collaborators


Sponsor:	Elysium Health
Responsible Party:	Sponsor
Collaborators:	KGK Science Inc.

Oversight


U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:	No

Study Description


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.
Detailed Description:

Conditions


Conditions:	Safety: Healthy Subjects
Keywords:	Healthy participants Dietary supplement Safety Tolerability Older Adults Basis Nicotinamide riboside Pterostilbene

Study Design


Study Type:	Interventional
Primary Purpose:	Other
Study Phase:	Phase 1
Interventional Study Model:	Parallel Assignment
Number of Arms:	3
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:	Randomized
Enrollment:	120 [Anticipated]

Arms and Interventions

Arms	Assigned Interventions
Experimental: Basis 250	Dietary Supplement: Basis 250
Experimental: Basis 500	Dietary Supplement: Basis 500
Placebo Comparator: Placebo	Dietary Supplement: Placebo

Outcome Measures


Primary Outcome Measures:
1.	Blood pressure [ Time Frame: 8 weeks ] Assessment of blood pressure
2.	Safety Blood Parameters [ Time Frame: 8 weeks ] Assessment of safety blood parameters: CBC, electrolytes (Na, K, Cl), kidney function (creatinine), liver function (AST, ALT, GGT and bilirubin)
3.	Heart Rate [ Time Frame: 8 weeks ] Assessment of heart rate
Secondary Outcome Measures:
1.	Physiological Performance [ Time Frame: 8 weeks ] 6 Minute Walk Test
2.	Physiological Performance [ Time Frame: 8 weeks ] 30 Second Chair Stand Test
3.	Physiological Performance [ Time Frame: 8 weeks ] Physical Activity Scale for the Elderly
4.	Body Weight [ Time Frame: 8 weeks ]
5.	Blood Pressure [ Time Frame: 8 weeks ]
6.	Serum Glucose [ Time Frame: 8 weeks ]
7.	Lipid Profile [ Time Frame: 8 weeks ]
8.	Quality of Life and Sleep Quality [ Time Frame: 8 weeks ] Health Assessment Questionnaire
9.	Quality of Life and Sleep Quality [ Time Frame: 8 weeks ] Older People's Quality of Life Questionnaires
10.	Blood NAD+ [ Time Frame: 8 weeks ]
Other Outcome Measures:
1.	Expression Profile of Peripheral Blood Mononuclear Cells [ Time Frame: 8 weeks ]
2.	Pain Assessment [ Time Frame: 8 weeks ] VAS Pain Scale
3.	Endothelial Function [ Time Frame: 8 weeks ] EndoPat

Eligibility


Minimum Age:	60 Years
Maximum Age:	80 Years
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	Yes
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

Contacts/Locations


Central Contact Person:	Malkanthi Evans, PhD Telephone: (519) 438-9374 Ext. 239 Email: mevans@kgksynergize.com
Study Officials:	Tetyana Pelipyagina, MD Principal Investigator KGK Science Inc.
Locations:	Canada, Ontario
	KGK Synergize Inc. [Recruiting] London, Ontario, Canada, N6A 5R8 Contact:Contact: Malkanthi Evans, PhD (519) 438-9374 Ext. 239 mevans@kgksynergize.com Contact:Principal Investigator: Tetyana Pelipyagina, MD

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