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OpenTrials
Completed

NCT Number: NCT02678611

A 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.

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Key information

Age range

60 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

KGK Synergize Inc.

London, Ontario, N6A 5R8, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Basis 250

Dietary Supplement

Basis 500

Dietary Supplement

Placebo

Dietary Supplement

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Elysium Health

Industry

Collaborators

  • KGK Science Inc.

Registry information

Official study title

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

Acronym: 15BSHE

Important dates

Study start
2016
Primary completion
2016
First posted
Feb 10, 2016
Registry last updated
Aug 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.