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

• ClinicalTrials.gov Identifier: NCT02678611
• Recruitment Status: Completed
• First Posted: February 10, 2016
• Last Update Posted: August 1, 2016
• Sponsor: Elysium Health
• Collaborator: KGK Science Inc.
• Information provided by (Responsible Party): Elysium Health

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.

Condition or disease	Intervention/treatment	Phase
Safety: Healthy Subjects	Dietary Supplement: Basis 250; Dietary Supplement: Basis 500; Dietary Supplement: Placebo	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Official Title: A Randomized, Double-blind, Placebo Controlled Study to Evaluate Safety and Health Benefits of Basis™ Among Elderly Subjects.
• Study Start Date: January 2016
• Actual Primary Completion Date: July 2016

Arms and Interventions

Arm	Intervention/treatment
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 Criteria

• Ages Eligible for Study: 60 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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 and Locations

Locations

Canada, Ontario

KGK Synergize Inc.

London, Ontario, Canada, N6A 5R8

Sponsors and Collaborators

Elysium Health

KGK Science Inc.

Investigators

• Principal Investigator: Tetyana Pelipyagina, MD; KGK Science Inc.

More Information

• Responsible Party: Elysium Health
• ClinicalTrials.gov Identifier: NCT02678611
• Other Study ID Numbers: 15BSHE
• First Posted: February 10, 2016
• Last Update Posted: August 1, 2016
• Last Verified: July 2016

Keywords provided by Elysium Health:

Healthy participants; Dietary supplement; Safety; Tolerability; Older Adults; Basis; Nicotinamide riboside; Pterostilbene