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

Phase 1

Completed

• Conditions: Safety: Healthy Subjects
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Basis 250; Dietary Supplement: Basis 500

• Registration Number: NCT02678611
• Lead Sponsor: Elysium Health

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

Not available

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-02-03
• Study First Submitted QC: 2016-02-09
• Study First Posted: 2016-02-10
• Status Verified: 2016-07
• Primary Completion: 2016-07
• Last Update Submitted: 2016-07-28
• Last Update Posted: 2016-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Basis 250	Basis 250	-
Basis 500	Basis 500	-

Primary Outcome Measures

Name	Time	Method
Heart Rate	8 weeks	Assessment of heart rate
Blood pressure	8 weeks	Assessment of blood pressure
Safety Blood Parameters	8 weeks	Assessment of safety blood parameters: CBC, electrolytes (Na, K, Cl), kidney function (creatinine), liver function (AST, ALT, GGT and bilirubin)

Secondary Outcome Measures

Name	Time	Method
Body Weight	8 weeks
Blood Pressure	8 weeks
Lipid Profile	8 weeks
Blood NAD+	8 weeks
Physiological Performance	8 weeks	Physical Activity Scale for the Elderly
Quality of Life and Sleep Quality	8 weeks	Older People's Quality of Life Questionnaires
Serum Glucose	8 weeks

Trial Locations

Locations (1)

KGK Synergize Inc.; 🇨🇦 London, Ontario, Canada