AgingMTDSSTNCT04641663
Multi-target Dietary Supplement Tolerability in an Aging Population (MTDSST)
A study testing Multi-target Dietary Supplement (MTDS) in people with Aging and Age-related Cognitive Decline, run by Douglas Boreham at 2 sites in Canada.
Trial summary
This study is being performed to determine if a multi-ingredient dietary supplement is safe and easy to take by healthy older adults. Participants will be required to take one of three different doses of the dietary supplement for 90 consecutive days and complete wellness surveys and a daily log while taking the… Read more about this study
- Who is it for?
- Ages 45 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging, Age-related Cognitive Decline
- What is being tested?
- Multi-target Dietary Supplement (MTDS)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 2 sitesCanada
- Study dates
- 3 Sep 2021to 15 Dec 2023
- Phase
- Interventional
- 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 45 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or Female subjects ages of 45 and older.
- Capable of providing informed consent
- Patients currently taking fluconazole, 3-hydroxy-3-methyl-glutaryl-CoA reductase (HMG-CoA) reductase inhibitors (i.e. "statin" drugs), or any other drug known to interfere with serum transaminase (i.e. liver enzymes), must have history of stable liver function test since first taking such drugs.
- Patients who usually and customarily take dietary supplements, including vitamins, must undergo a two-week washout period
Who cannot join
- Exposure to any investigational drug within 90 days of the beginning of this study
- Known human immunodeficiency virus (HIV) seropositivity or Acquired Immunodeficiency Syndrome (AIDS); history of Hepatitis B (HBV), Hepatitis C (HCV) vital infection, unexplained elevated serum transaminase, or other hepatic disease. NOTE: HIV, HCV, and HBV testing will not be performed as part of screening.
- History of cancer within the last 5 years, except for basal or squamous cell cancer.
- Recent COVID-19 infection.
- Allergy to fish (specifically sardines, anchovies or mackerel) or any of the investigational product components
- Concomitant use, or use within less than a two-week period, of any other dietary supplement
Show all 20Show fewer
- Concomitant use of any drug known to interfere with laboratory measures such as:
- Niaspan (extended release niacin)
- Lamisil (terbinafine HCl)
- Chronic use of acetaminophen (>1,500 mg/day) (occasional use for minor aches and pains is excluded from this restriction)
- Newly prescribed (< 90days) HMG-CoA reductase inhibitors ("statin medications"), or patients currently on statin medications who have previously shown evidence of elevated serum transaminases
- Currently diagnosed with multiple sclerosis, systemic lupus erythematosis, or other autoimmune disorders known to interfere with laboratory measures
- History of alcoholism or drug abuse, unless it is determined that such past use would not influence laboratory measures (DSN4 criteria)
- Any other active disease of a life-threatening nature or laboratory abnormality that, in the judgment of the investigator, may interfere with the interpretation, or increase risk of patient participation
- Conditions that require nutritional therapy, such as:
- Pernicious anemia
- Iron-deficiency anemia
- Hartnup Disease or Pellagra
- Scurvy
- Beriberi-induced Endemic Neuritis
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Northern Ontario School of Medicine - Elliot Lake site
Elliot Lake, Ontario, P5A 1X2
McMaster University - Behavioural Neurosciences
Hamilton, Ontario, L8S 4K1
About this study
Official title: Clinical Trial to Assess Tolerability and Availability of a Multi-target Dietary Supplement in an Aging Population
This study is being performed to determine if a multi-ingredient dietary supplement is safe and easy to take by healthy older adults. Participants will be required to take one of three different doses of the dietary supplement for 90 consecutive days and complete wellness surveys and a daily log while taking the supplement. Participants will also provide blood samples at the start of the study, after 30 days, and at the end of the study which will help determine how participants respond to the supplement.
Read the detailed description
Likely because of the highly complex nature of aging, there has been little success reducing age-related physical and cognitive deterioration. The predominant approach has been to manage emergent symptoms rather than mitigate the cellular mechanisms driving the degenerative processes underlying aging. Additionally, the multifaceted and complex etiology of aging makes it extremely difficult to provide effective interventions within current treatment paradigms. The medical community has established that preventative measures are the most effective means of slowing the progression of age-associated deterioration, however effective methods or interventions have not been established.
The Multi-Target Dietary Supplement (MTDS) was designed to simultaneously target and support the cellular processes implicated in the progression of the aging phenotype (oxidative stress, inflammatory processes, insulin resistance, and membrane and mitochondrial deterioration). The MTDS is unique in that it was specifically designed as a multi-target intervention to support the complex cellular perturbations associated with aging. Components of the formulation were chosen based on scientific consensus of documented effectiveness for one or more of the targeted processes, long-term evidence of safety, and synergistic or additive interactions between components.
In more than 20 years of pre-clinical research, the MTDS has demonstrated significant beneficial impacts in animal models of aging and age-associated disease. The MTDS has resulted in significant reductions in both acute and chronic oxidative stress, greatly improved mitochondrial function and efficiency, significantly reduced inflammatory processes and improved glucose metabolism. Signal transduction is normalized to youthful levels in aged animals, including key pathways implicated in aging (unpublished data). On a functional level, MTDS treatment has resulted in increased longevity of 10 to 28% in normal and accelerated aging phenotypes, respectively. Concomitant improvements in mobility, activity levels, muscle strength (exercise mimetic) and overall body condition in aged animals were observed. Dramatic reductions in the incidence of muscle wasting, arthritic processes, and cataracts were also observed. Sensory and cognitive acuity were protected and frequently enhanced in aged animals, with significant improvements in visual and olfactory function observed in a broad range of tasks. MTDS treatment has demonstrated profound sparing from age-related neuronal losses and corresponding protection of neurogenesis and enhanced synaptogenesis, resulting in dramatically improved cognition in aged animals. The quantity of data indicating MTDS efficacy in pre-clinical studies is considerable, however the effects of the MTDS in humans, although positive, remains anecdotal. This tolerability study is the critical first step to begin assessment of the efficacy of the MTDS in human populations. If even a portion of these protective effects of the MTDS are translatable from mice to humans, the positive impacts for the aging population and Ontario's healthcare system could be profound.
This is a multi-center, three-arm study designed to evaluate the safety of a dietary supplement at three dosing regimes for 90 days. Initially, 45 healthy volunteers will be randomly assigned to one of three dose regimes: 1) 100% of recommended daily dose (RDD), 2) 80% of recommended daily dose or 3) 60% of recommended daily dose. Dosing regimes are based on levels of the MORNING tablet doses, all groups will receive the full recommended dose for both EVENING and OMEGA doses. Written informed consent will be obtained and a medical history and health assessment will be performed. The investigator will determine whether the subject meets all inclusion and exclusion criteria. Health assessments will be made at baseline, 30 days and 90 days. Adverse events, concomitant medications, and product administration will be recorded throughout the study.
Compliance, safety, and tolerability parameters are the primary focus of this study; however the probability of serious adverse events is extremely low given the long safety history of safety of the vitamins and nutraceuticals that comprise the MTDS.
The primary objective is to evaluate the safety and tolerability of the MTDS regimen in terms of its administration at 3 dosing regimes for 90 consecutive days with respect to micronutrient levels, laboratory tests and adverse events.
The secondary objectives include:
- monitoring compliance of taking the MTDS,
- monitoring wellness as measured by the 36-Item Short Form Survey (SF-36) scale and daily journal, over the 90-day administration of the MTDS, and
- to assess MTDS absorption through plasma micronutrient testing, at baseline, 30 days and 90 days following administration of the test agent.
- Conditions
- Aging, Age-related Cognitive Decline
- Being tested
- Multi-target Dietary Supplement (MTDS)
- Keywords
- Dietary Supplement, Aging, Safety, Tolerability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-target Dietary Supplement (MTDS)Dietary supplement
Also called AS-10 Plus
The Multi-Target Dietary Supplement (MTDS) is comprised of 51 ingredients designed to simultaneously target and support the cellular processes implicated in the progression of the aging phenotype (oxidative stress, inflammatory processes, insulin resistance, and membrane and mitochondrial deterioration). The MTDS is unique in that it was specifically designed as a multi-target intervention to support the complex cellular perturbations associated with aging. Components of the formulation were chosen based on scientific consensus of documented effectiveness for one or more of the targeted processes, long-term evidence of safety, and synergistic or additive interactions between components.
The MTDS is divided into morning and evening doses to maximize availability of the components to the peak activity level of the cellular processes that require those components.
| Study group | Role | What they receive |
|---|---|---|
| 100 RDD | Experimental | 100% of recommended daily dose (RDD) of the MORNING tablet dose (5 tablets), all groups will receive the full recommended dose for both EVENING (3 tablets) and OMEGA (2 softgels) doses. Receives: Dietary Supplement: Multi-target Dietary Supplement (MTDS) |
| 80 RDD | Experimental | 80% of recommended daily dose of the MORNING tablet dose (4 tablets), all groups will receive the full recommended dose for both EVENING (3 tablets) and OMEGA (2 softgels) doses. Receives: Dietary Supplement: Multi-target Dietary Supplement (MTDS) |
| 60 RDD | Experimental | 60% of recommended daily dose of the MORNING tablet dose (3 tablets), all groups will receive the full recommended dose for both EVENING (3 tablets) and OMEGA (2 softgels) doses. Receives: Dietary Supplement: Multi-target Dietary Supplement (MTDS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-Related Adverse Events (AE) as Assessed by CTCAE v5.0
Subjects are instructed to log any AEs that occur at any time during the study in the study journal. Participants will be contacted by phone after 7 days on the MTDS to assess any occurrence of AEs. Reported or observed AEs will be documented and followed to resolution.
Measured: out to 90 days
Hematocrit (%)
Safety Assessment in Hematology
Measured: out to 90 days
Hemoglobin (g/L)
Safety Assessment in Hematology
Measured: out to 90 days
Erythrocytes (10^12/L)
Safety Assessment in Hematology
Measured: out to 90 days
Leukocytes (10^9/L)
Safety Assessment in Hematology
Measured: out to 90 days
Basophils (10^3/uL)
Safety Assessment in Hematology
Measured: out to 90 days
Basophils/Leukocytes (%)
Safety Assessment in Hematology
Measured: out to 90 days
Eosinophils (10^9/L)
Safety Assessment in Hematology
Measured: out to 90 days
Eosinophils/Leukocytes (%)
Safety Assessment in Hematology
Measured: out to 90 days
Lymphocytes (10^9/L)
Safety Assessment in Hematology
Measured: out to 90 days
Lymphocytes/Leukocytes (%)
Safety Assessment in Hematology
Measured: out to 90 days
Monocytes (10^9/L)
Safety Assessment in Hematology
Measured: out to 90 days
Monocytes/Leukocytes (%)
Safety Assessment in Hematology
Measured: out to 90 days
Neutrophils (10^9/L)
Safety Assessment in Hematology
Measured: out to 90 days
Neutrophils/Leukocytes (%)
Safety Assessment in Hematology
Measured: out to 90 days
Platelet Count (10^9/L)
Safety Assessment in Hematology
Measured: out to 90 days
Serum Glucose (mmol/L)
Safety Assessment in Serum Chemistry
Measured: out to 90 days
Sodium (mmol/L)
Safety Assessment in Serum Chemistry
Measured: out to 90 days
Potassium (mmol/L)
Safety Assessment in Serum Chemistry
Measured: out to 90 days
Calcium (mmol/L)
Safety Assessment in Serum Chemistry
Measured: out to 90 days
Chloride (mmol/L)
Safety Assessment in Serum Chemistry
Measured: out to 90 days
Urea (mmol/L)
Safety Assessment in Serum Chemistry
Measured: out to 90 days
Creatinine (umol/L)
Safety Assessment in Serum Chemistry
Measured: out to 90 days
Urate (umol/L)
Safety Assessment in Serum Chemistry
Measured: out to 90 days
Albumin (g/L)
Safety Assessment in Serum Chemistry
Measured: out to 90 days
Alkaline Phosphatase (U/L)
Safety Assessment in Serum Chemistry
Measured: out to 90 days
Aspartate Phosphatase (U/L)
Safety Assessment in Serum Chemistry
Measured: out to 90 days
Alanine Transaminase (U/L)
Safety Assessment in Serum Chemistry
Measured: out to 90 days
Gamma Glutamyl Transpeptidase (U/L)
Safety Assessment in Serum Chemistry
Measured: out to 90 days
Total Bilirubin (umol/L)
Safety Assessment in Serum Chemistry
Measured: out to 90 days
Direct Bilirubin (umol/L)
Safety Assessment in Serum Chemistry
Measured: out to 90 days
Lactate Dehydrogenase (U/L)
Safety Assessment in Serum Chemistry
Measured: out to 90 days
High Sensitivity C-Reactive Protein (mg/L)
Safety Assessment in Serum Chemistry
Measured: out to 90 days
Secondary outcomes (24)
Vitamin A (mg/L)
Plasma Micronutrient Levels
Measured: out to 90 days
Vitamin B1 (mg/L)
Plasma Micronutrient Levels
Measured: out to 90 days
Vitamin B2 (mg/L)
Plasma Micronutrient Levels
Measured: out to 90 days
Vitamin B3 (mg/L)
Plasma Micronutrient Levels
Measured: out to 90 days
Vitamin B6 (mg/L)
Plasma Micronutrient Levels
Measured: out to 90 days
Vitamin B12 (mg/L)
Plasma Micronutrient Levels
Measured: out to 90 days
Biotin (mg/L)
Plasma Micronutrient Levels
Measured: out to 90 days
Folate (mg/L)
Plasma Micronutrient Levels
Measured: out to 90 days
Pantothenate (mg/L)
Plasma Micronutrient Levels
Measured: out to 90 days
Vitamin C (mg/L)
Plasma Micronutrient Levels
Measured: out to 90 days
Vitamin D3 (mg/L)
Plasma Micronutrient Levels
Measured: out to 90 days
Vitamin K2 (mg/L)
Plasma Micronutrient Levels
Measured: out to 90 days
Magnesium (mg/L)
Plasma Micronutrient Levels
Measured: out to 90 days
Manganese (mg/L)
Plasma Micronutrient Levels
Measured: out to 90 days
Zinc (mg/L)
Plasma Micronutrient Levels
Measured: out to 90 days
Copper (mg/L)
Plasma Micronutrient Levels
Measured: out to 90 days
Alpha Lipoic Acid (mg/L)
Plasma Micronutrient Levels
Measured: out to 90 days
Glutamine (mg/L)
Plasma Micronutrient Levels
Measured: out to 90 days
Glutathione (mg/L)
Plasma Micronutrient Levels
Measured: out to 90 days
Carnitine (mg/L)
Plasma Micronutrient Levels
Measured: out to 90 days
Choline (mg/L)
Plasma Micronutrient Levels
Measured: out to 90 days
Inositol (mg/L)
Plasma Micronutrient Levels
Measured: out to 90 days
Coenzyme Q10 (mg/L)
Plasma Micronutrient Levels
Measured: out to 90 days
36-Item Short Form Survey (SF-36)
The SF-36 wellness questionnaire will be used to assess the health status of subjects. There are 36 individual questions which identify eight different facets of wellness. These have been described as physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. These facets are further collapsed into physical and mental component summaries. The eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This questionnaire will be included in the study booklet given to each subject, and will be self administered.
Measured: up to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2020
- Study start3 Sep 2021
- Primary completion21 Sep 2023 (estimated)
- Study completion15 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- participants will be taking either 60%, 80% or 100% of the recommended daily dose of the dietary supplement.
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Douglas Boreham
- Sponsor type
- University, hospital or other
- Collaborators
- McMaster University
- Responsible party
- Sponsor-investigator, Douglas Boreham, Northern Ontario School of Medicine
- Investigators
- Douglas Boreham, PhD, Principal investigator, Northern Ontario School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04641663
- Sponsor's protocol ID
- MTDS-001
- Acronym
- MTDSST
- Status last verified
- May 2023
- First submitted
- 12 Nov 2020
- Last updated
- 17 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared with researchers outside the study team.
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial to Assess Tolerability and Availability of a Multi-target Dietary Supplement in an Aging Population
- ClinicalTrials.gov ID
- NCT04641663
- Acronym / sponsor ID
- MTDSST / MTDS-001
- Conditions
- Aging, Age-related Cognitive Decline
- Keywords
- Dietary Supplement, Aging, Safety, Tolerability
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Douglas BorehamUniversity, hospital or other
- Collaborators
- McMaster University
- Study start
- 3 Sep 2021 (actual)
- Primary completion
- 21 Sep 2023 (estimated)
- Study completion
- 15 Dec 2023 (estimated)
- First posted
- 24 Nov 2020 (actual)
- 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 is being performed to determine if a multi-ingredient dietary supplement is safe and easy to take by healthy older adults. Participants will be required to take one of three different doses of the dietary supplement for 90 consecutive days and complete wellness surveys and a daily log while taking the supplement. Participants will also provide blood samples at the start of the study, after 30 days, and at the end of the study which will help determine how participants respond to the supplement.
Detailed description
Likely because of the highly complex nature of aging, there has been little success reducing age-related physical and cognitive deterioration. The predominant approach has been to manage emergent symptoms rather than mitigate the cellular mechanisms driving the degenerative processes underlying aging. Additionally, the multifaceted and complex etiology of aging makes it extremely difficult to provide effective interventions within current treatment paradigms. The medical community has established that preventative measures are the most effective means of slowing the progression of age-associated deterioration, however effective methods or interventions have not been established.
The Multi-Target Dietary Supplement (MTDS) was designed to simultaneously target and support the cellular processes implicated in the progression of the aging phenotype (oxidative stress, inflammatory processes, insulin resistance, and membrane and mitochondrial deterioration). The MTDS is unique in that it was specifically designed as a multi-target intervention to support the complex cellular perturbations associated with aging. Components of the formulation were chosen based on scientific consensus of documented effectiveness for one or more of the targeted processes, long-term evidence of safety, and synergistic or additive interactions between components.
In more than 20 years of pre-clinical research, the MTDS has demonstrated significant beneficial impacts in animal models of aging and age-associated disease. The MTDS has resulted in significant reductions in both acute and chronic oxidative stress, greatly improved mitochondrial function and efficiency, significantly reduced inflammatory processes and improved glucose metabolism. Signal transduction is normalized to youthful levels in aged animals, including key pathways implicated in aging (unpublished data). On a functional level, MTDS treatment has resulted in increased longevity of 10 to 28% in normal and accelerated aging phenotypes, respectively. Concomitant improvements in mobility, activity levels, muscle strength (exercise mimetic) and overall body condition in aged animals were observed. Dramatic reductions in the incidence of muscle wasting, arthritic processes, and cataracts were also observed. Sensory and cognitive acuity were protected and frequently enhanced in aged animals, with significant improvements in visual and olfactory function observed in a broad range of tasks. MTDS treatment has demonstrated profound sparing from age-related neuronal losses and corresponding protection of neurogenesis and enhanced synaptogenesis, resulting in dramatically improved cognition in aged animals. The quantity of data indicating MTDS efficacy in pre-clinical studies is considerable, however the effects of the MTDS in humans, although positive, remains anecdotal. This tolerability study is the critical first step to begin assessment of the efficacy of the MTDS in human populations. If even a portion of these protective effects of the MTDS are translatable from mice to humans, the positive impacts for the aging population and Ontario's healthcare system could be profound.
This is a multi-center, three-arm study designed to evaluate the safety of a dietary supplement at three dosing regimes for 90 days. Initially, 45 healthy volunteers will be randomly assigned to one of three dose regimes: 1) 100% of recommended daily dose (RDD), 2) 80% of recommended daily dose or 3) 60% of recommended daily dose. Dosing regimes are based on levels of the MORNING tablet doses, all groups will receive the full recommended dose for both EVENING and OMEGA doses. Written informed consent will be obtained and a medical history and health assessment will be performed. The investigator will determine whether the subject meets all inclusion and exclusion criteria. Health assessments will be made at baseline, 30 days and 90 days. Adverse events, concomitant medications, and product administration will be recorded throughout the study.
Compliance, safety, and tolerability parameters are the primary focus of this study; however the probability of serious adverse events is extremely low given the long safety history of safety of the vitamins and nutraceuticals that comprise the MTDS.
The primary objective is to evaluate the safety and tolerability of the MTDS regimen in terms of its administration at 3 dosing regimes for 90 consecutive days with respect to micronutrient levels, laboratory tests and adverse events.
The secondary objectives include:
- monitoring compliance of taking the MTDS,
- monitoring wellness as measured by the 36-Item Short Form Survey (SF-36) scale and daily journal, over the 90-day administration of the MTDS, and
- to assess MTDS absorption through plasma micronutrient testing, at baseline, 30 days and 90 days following administration of the test agent.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- participants will be taking either 60%, 80% or 100% of the recommended daily dose of the dietary supplement.
| Arm | Type | Receives |
|---|---|---|
| 100 RDD | Experimental | Dietary Supplement: Multi-target Dietary Supplement (MTDS)100% of recommended daily dose (RDD) of the MORNING tablet dose (5 tablets), all groups will receive the full recommended dose for both EVENING (3 tablets) and OMEGA (2 softgels) doses. |
| 80 RDD | Experimental | Dietary Supplement: Multi-target Dietary Supplement (MTDS)80% of recommended daily dose of the MORNING tablet dose (4 tablets), all groups will receive the full recommended dose for both EVENING (3 tablets) and OMEGA (2 softgels) doses. |
| 60 RDD | Experimental | Dietary Supplement: Multi-target Dietary Supplement (MTDS)60% of recommended daily dose of the MORNING tablet dose (3 tablets), all groups will receive the full recommended dose for both EVENING (3 tablets) and OMEGA (2 softgels) doses. |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or Female subjects ages of 45 and older.
- Capable of providing informed consent
- Patients currently taking fluconazole, 3-hydroxy-3-methyl-glutaryl-CoA reductase (HMG-CoA) reductase inhibitors (i.e. "statin" drugs), or any other drug known to interfere with serum transaminase (i.e. liver enzymes), must have history of stable liver function test since first taking such drugs.
- Patients who usually and customarily take dietary supplements, including vitamins, must undergo a two-week washout period
Key exclusion criteria (20 listed)
- Exposure to any investigational drug within 90 days of the beginning of this study
- Known human immunodeficiency virus (HIV) seropositivity or Acquired Immunodeficiency Syndrome (AIDS); history of Hepatitis B (HBV), Hepatitis C (HCV) vital infection, unexplained elevated serum transaminase, or other hepatic disease. NOTE: HIV, HCV, and HBV testing will not be performed as part of screening.
- History of cancer within the last 5 years, except for basal or squamous cell cancer.
- Recent COVID-19 infection.
- Allergy to fish (specifically sardines, anchovies or mackerel) or any of the investigational product components
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 |
|---|---|---|
| Multi-target Dietary Supplement (MTDS)Also: AS-10 PlusThe Multi-Target Dietary Supplement (MTDS) is comprised of 51 ingredients designed to simultaneously target and support the cellular processes implicated in the progression of the aging phenotype (oxidative stress, inflammatory processes, insulin resistance, and membrane and mitochondrial deterioration). The MTDS is unique in that it was specifically designed as a multi-target intervention to support the complex cellular perturbations associated with aging. Components of the formulation were chosen based on scientific consensus of documented effectiveness for one or more of the targeted processes, long-term evidence of safety, and synergistic or additive interactions between components. The MTDS is divided into morning and evening doses to maximize availability of the components to the peak activity level of the cellular processes that require those components. | Dietary supplement | 100 RDD, 60 RDD, 80 RDD |
Primary outcome
Number of Participants With Treatment-Related Adverse Events (AE) as Assessed by CTCAE v5.0
Time frame: out to 90 days
Subjects are instructed to log any AEs that occur at any time during the study in the study journal. Participants will be contacted by phone after 7 days on the MTDS to assess any occurrence of AEs. Reported or observed AEs will be documented and followed to resolution.
Hematocrit (%)
Time frame: out to 90 days
Safety Assessment in Hematology
Hemoglobin (g/L)
Time frame: out to 90 days
Safety Assessment in Hematology
Erythrocytes (10^12/L)
Time frame: out to 90 days
Safety Assessment in Hematology
Leukocytes (10^9/L)
Time frame: out to 90 days
Safety Assessment in Hematology
Basophils (10^3/uL)
Time frame: out to 90 days
Safety Assessment in Hematology
Basophils/Leukocytes (%)
Time frame: out to 90 days
Safety Assessment in Hematology
Eosinophils (10^9/L)
Time frame: out to 90 days
Safety Assessment in Hematology
Eosinophils/Leukocytes (%)
Time frame: out to 90 days
Safety Assessment in Hematology
Lymphocytes (10^9/L)
Time frame: out to 90 days
Safety Assessment in Hematology
Lymphocytes/Leukocytes (%)
Time frame: out to 90 days
Safety Assessment in Hematology
Monocytes (10^9/L)
Time frame: out to 90 days
Safety Assessment in Hematology
Monocytes/Leukocytes (%)
Time frame: out to 90 days
Safety Assessment in Hematology
Neutrophils (10^9/L)
Time frame: out to 90 days
Safety Assessment in Hematology
Neutrophils/Leukocytes (%)
Time frame: out to 90 days
Safety Assessment in Hematology
Platelet Count (10^9/L)
Time frame: out to 90 days
Safety Assessment in Hematology
Serum Glucose (mmol/L)
Time frame: out to 90 days
Safety Assessment in Serum Chemistry
Sodium (mmol/L)
Time frame: out to 90 days
Safety Assessment in Serum Chemistry
Potassium (mmol/L)
Time frame: out to 90 days
Safety Assessment in Serum Chemistry
Calcium (mmol/L)
Time frame: out to 90 days
Safety Assessment in Serum Chemistry
Chloride (mmol/L)
Time frame: out to 90 days
Safety Assessment in Serum Chemistry
Urea (mmol/L)
Time frame: out to 90 days
Safety Assessment in Serum Chemistry
Creatinine (umol/L)
Time frame: out to 90 days
Safety Assessment in Serum Chemistry
Urate (umol/L)
Time frame: out to 90 days
Safety Assessment in Serum Chemistry
Albumin (g/L)
Time frame: out to 90 days
Safety Assessment in Serum Chemistry
Alkaline Phosphatase (U/L)
Time frame: out to 90 days
Safety Assessment in Serum Chemistry
Aspartate Phosphatase (U/L)
Time frame: out to 90 days
Safety Assessment in Serum Chemistry
Alanine Transaminase (U/L)
Time frame: out to 90 days
Safety Assessment in Serum Chemistry
Gamma Glutamyl Transpeptidase (U/L)
Time frame: out to 90 days
Safety Assessment in Serum Chemistry
Total Bilirubin (umol/L)
Time frame: out to 90 days
Safety Assessment in Serum Chemistry
Direct Bilirubin (umol/L)
Time frame: out to 90 days
Safety Assessment in Serum Chemistry
Lactate Dehydrogenase (U/L)
Time frame: out to 90 days
Safety Assessment in Serum Chemistry
High Sensitivity C-Reactive Protein (mg/L)
Time frame: out to 90 days
Safety Assessment in Serum Chemistry
24 secondary outcomes
Vitamin A (mg/L)
Time frame: out to 90 days
Vitamin B1 (mg/L)
Time frame: out to 90 days
Vitamin B2 (mg/L)
Time frame: out to 90 days
Vitamin B3 (mg/L)
Time frame: out to 90 days
Vitamin B6 (mg/L)
Time frame: out to 90 days
Vitamin B12 (mg/L)
Time frame: out to 90 days
Biotin (mg/L)
Time frame: out to 90 days
Folate (mg/L)
Time frame: out to 90 days
Pantothenate (mg/L)
Time frame: out to 90 days
Vitamin C (mg/L)
Time frame: out to 90 days
Vitamin D3 (mg/L)
Time frame: out to 90 days
Vitamin K2 (mg/L)
Time frame: out to 90 days
Magnesium (mg/L)
Time frame: out to 90 days
Manganese (mg/L)
Time frame: out to 90 days
Zinc (mg/L)
Time frame: out to 90 days
Copper (mg/L)
Time frame: out to 90 days
Alpha Lipoic Acid (mg/L)
Time frame: out to 90 days
Glutamine (mg/L)
Time frame: out to 90 days
Glutathione (mg/L)
Time frame: out to 90 days
Carnitine (mg/L)
Time frame: out to 90 days
Choline (mg/L)
Time frame: out to 90 days
Inositol (mg/L)
Time frame: out to 90 days
Coenzyme Q10 (mg/L)
Time frame: out to 90 days
36-Item Short Form Survey (SF-36)
Time frame: up to 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2023.
- Individual participant dataSharing planned: No. IPD will not be shared with researchers outside the study team.
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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.
Douglas Boreham, PhD principal investigator
Northern Ontario School of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multi-target Dietary Supplement (MTDS) in people with Aging and Age-related Cognitive Decline, run by Douglas Boreham at 2 sites 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 4 inclusion and 20 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: status not confirmed, as of the sponsor's last update on 17 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
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?
Number of Participants With Treatment-Related Adverse Events (AE) as Assessed by CTCAE v5.0 (time frame: out to 90 days). The study lists 33 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 17 May 2023.