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

A Randomized, Double-blind, Placebo Controlled Study to Evaluate Safety and Health Benefits of Basis™ Among Elderly Subjects.

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.

Study Overview

• Status: Completed
• Conditions: Safety: Healthy Subjects
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Basis 250; Dietary supplement: Basis 500

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 1

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6A 5R8
      • KGK Synergize Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Dietary supplement: Placebo
Experimental: Basis 250	Dietary supplement: Basis 250
Experimental: Basis 500	Dietary supplement: Basis 500

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood pressure	Assessment of blood pressure	8 weeks
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
Heart Rate	Assessment of heart rate	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood Pressure		8 weeks
Physiological Performance	6 Minute Walk Test	8 weeks
Physiological Performance	30 Second Chair Stand Test	8 weeks
Physiological Performance	Physical Activity Scale for the Elderly	8 weeks
Body Weight		8 weeks
Serum Glucose		8 weeks
Lipid Profile		8 weeks
Quality of Life and Sleep Quality	Health Assessment Questionnaire	8 weeks
Quality of Life and Sleep Quality	Older People's Quality of Life Questionnaires	8 weeks
Blood NAD+		8 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Expression Profile of Peripheral Blood Mononuclear Cells		8 weeks
Pain Assessment	VAS Pain Scale	8 weeks
Endothelial Function	EndoPat	8 weeks

Collaborators and Investigators

• Sponsor: Elysium Health
• Collaborators: KGK Science Inc.

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: February 3, 2016
• First Submitted That Met QC Criteria: February 9, 2016
• First Posted (Estimate): February 10, 2016

Study Record Updates

• Last Update Posted (Estimate): August 1, 2016
• Last Update Submitted That Met QC Criteria: July 28, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: Safety; Dietary supplement; Older Adults; Healthy participants; Tolerability; Pterostilbene; Nicotinamide riboside; Basis
• Other Study ID Numbers: 15BSHE