Safety: Healthy SubjectsPhase 115BSHENCT02678611
A Study to Evaluate Safety and Health Benefits of Basis™ Among Elderly Subjects.
A Phase 1 study testing Basis 250 and Basis 500 in people with Safety: Healthy Subjects, run by Elysium Health at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Safety: Healthy Subjects
- What is being tested?
- Basis 250 and Basis 500
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2016to Jul 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Safety: Healthy Subjects
- Being tested
- Basis 250, Basis 500, Placebo
- Keywords
- Healthy participants, Dietary supplement, Safety, Tolerability, Older Adults, Basis, Nicotinamide riboside, Pterostilbene
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Basis 250Dietary supplement
Basis 500Dietary supplement
PlaceboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Basis 250 | Experimental | Not described Receives: Dietary Supplement: Basis 250 |
| Basis 500 | Experimental | Not described Receives: Dietary Supplement: Basis 500 |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure
Assessment of blood pressure
Measured: 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)
Measured: 8 weeks
Heart Rate
Assessment of heart rate
Measured: 8 weeks
Secondary outcomes (10)
Physiological Performance
6 Minute Walk Test
Measured: 8 weeks
Physiological Performance
30 Second Chair Stand Test
Measured: 8 weeks
Physiological Performance
Physical Activity Scale for the Elderly
Measured: 8 weeks
Body Weight
Measured: 8 weeks
Blood Pressure
Measured: 8 weeks
Serum Glucose
Measured: 8 weeks
Lipid Profile
Measured: 8 weeks
Quality of Life and Sleep Quality
Health Assessment Questionnaire
Measured: 8 weeks
Quality of Life and Sleep Quality
Older People's Quality of Life Questionnaires
Measured: 8 weeks
Blood NAD+
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2016 (estimated)
- Study startJan 2016
- Primary completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Safety: Healthy SubjectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elysium Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- KGK Science Inc.
- Responsible party
- Sponsor
- Investigators
- Tetyana Pelipyagina, MD, Principal investigator, KGK Science Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02678611
- Sponsor's protocol ID
- 15BSHE
- Acronym
- 15BSHE
- Status last verified
- Jul 2016
- First submitted
- 3 Feb 2016
- Last updated
- 1 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo Controlled Study to Evaluate Safety and Health Benefits of Basis™ Among Elderly Subjects.
- ClinicalTrials.gov ID
- NCT02678611
- Acronym / sponsor ID
- 15BSHE / 15BSHE
- Conditions
- Safety: Healthy Subjects
- Keywords
- Healthy participants, Dietary supplement, Safety, Tolerability, Older Adults, Basis, Nicotinamide riboside, Pterostilbene
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Elysium HealthIndustry (pharma, biotech, devices)
- Collaborators
- KGK Science Inc.
- Study start
- Jan 2016
- Primary completion
- Jul 2016 (actual)
- First posted
- 10 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Basis 250 | Experimental | Dietary Supplement: Basis 250 |
| Basis 500 | Experimental | Dietary Supplement: Basis 500 |
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Basis 250 | Dietary supplement | Basis 250 |
| Basis 500 | Dietary supplement | Basis 500 |
| Placebo | Dietary supplement | Placebo |
Primary outcome
Blood pressure
Time frame: 8 weeks
Assessment of blood pressure
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)
Heart Rate
Time frame: 8 weeks
Assessment of heart rate
10 secondary outcomes
Physiological Performance
Time frame: 8 weeks
Physiological Performance
Time frame: 8 weeks
Physiological Performance
Time frame: 8 weeks
Body Weight
Time frame: 8 weeks
Blood Pressure
Time frame: 8 weeks
Serum Glucose
Time frame: 8 weeks
Lipid Profile
Time frame: 8 weeks
Quality of Life and Sleep Quality
Time frame: 8 weeks
Quality of Life and Sleep Quality
Time frame: 8 weeks
Blood NAD+
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tetyana Pelipyagina, MD principal investigator
KGK Science Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Basis 250 and Basis 500 in people with Safety: Healthy Subjects, run by Elysium Health at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood pressure (time frame: 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2016.