An interventional study of Multi-target Dietary Supplement (MTDS) in Aging and Age-related Cognitive Decline, sponsored by Douglas Boreham. Enrolling by invitation at 2 sites in Canada. Open to participants aged 45 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-05-17.
Sponsored by Douglas Boreham · Not applicable, Interventional, and Treatment
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.
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:
3,843 studies on the registry are indexed under Cognitive Dysfunction; 1,100 are open to participants now.
This study's planned enrollment of 70 is close to the median of 65 across 2,808 interventional studies indexed under Cognitive Dysfunction.
Browse Cognitive Dysfunction studies →This is the only study on the registry with Douglas Boreham as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Concomitant use of any drug known to interfere with laboratory measures such as:
Conditions that require nutritional therapy, such as:
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.
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.
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.
Dietary Supplement: Multi-target Dietary Supplement (MTDS)
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.
Also known as: AS-10 Plus
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.
Time frame: out to 90 days
Hematocrit (%)
Safety Assessment in Hematology
Time frame: out to 90 days
Hemoglobin (g/L)
Safety Assessment in Hematology
Time frame: out to 90 days
Erythrocytes (10^12/L)
Safety Assessment in Hematology
Time frame: out to 90 days
Leukocytes (10^9/L)
Safety Assessment in Hematology
Time frame: out to 90 days
Basophils (10^3/uL)
Safety Assessment in Hematology
Time frame: out to 90 days
Basophils/Leukocytes (%)
Safety Assessment in Hematology
Time frame: out to 90 days
Eosinophils (10^9/L)
Safety Assessment in Hematology
Time frame: out to 90 days
Eosinophils/Leukocytes (%)
Safety Assessment in Hematology
Time frame: out to 90 days
Lymphocytes (10^9/L)
Safety Assessment in Hematology
Time frame: out to 90 days
Lymphocytes/Leukocytes (%)
Safety Assessment in Hematology
Time frame: out to 90 days
Monocytes (10^9/L)
Safety Assessment in Hematology
Time frame: out to 90 days
Monocytes/Leukocytes (%)
Safety Assessment in Hematology
Time frame: out to 90 days
Neutrophils (10^9/L)
Safety Assessment in Hematology
Time frame: out to 90 days
Neutrophils/Leukocytes (%)
Safety Assessment in Hematology
Time frame: out to 90 days
Platelet Count (10^9/L)
Safety Assessment in Hematology
Time frame: out to 90 days
Serum Glucose (mmol/L)
Safety Assessment in Serum Chemistry
Time frame: out to 90 days
Sodium (mmol/L)
Safety Assessment in Serum Chemistry
Time frame: out to 90 days
Potassium (mmol/L)
Safety Assessment in Serum Chemistry
Time frame: out to 90 days
Calcium (mmol/L)
Safety Assessment in Serum Chemistry
Time frame: out to 90 days
Chloride (mmol/L)
Safety Assessment in Serum Chemistry
Time frame: out to 90 days
Urea (mmol/L)
Safety Assessment in Serum Chemistry
Time frame: out to 90 days
Creatinine (umol/L)
Safety Assessment in Serum Chemistry
Time frame: out to 90 days
Urate (umol/L)
Safety Assessment in Serum Chemistry
Time frame: out to 90 days
Albumin (g/L)
Safety Assessment in Serum Chemistry
Time frame: out to 90 days
Alkaline Phosphatase (U/L)
Safety Assessment in Serum Chemistry
Time frame: out to 90 days
Aspartate Phosphatase (U/L)
Safety Assessment in Serum Chemistry
Time frame: out to 90 days
Alanine Transaminase (U/L)
Safety Assessment in Serum Chemistry
Time frame: out to 90 days
Gamma Glutamyl Transpeptidase (U/L)
Safety Assessment in Serum Chemistry
Time frame: out to 90 days
Total Bilirubin (umol/L)
Safety Assessment in Serum Chemistry
Time frame: out to 90 days
Direct Bilirubin (umol/L)
Safety Assessment in Serum Chemistry
Time frame: out to 90 days
Lactate Dehydrogenase (U/L)
Safety Assessment in Serum Chemistry
Time frame: out to 90 days
High Sensitivity C-Reactive Protein (mg/L)
Safety Assessment in Serum Chemistry
Time frame: out to 90 days
Vitamin A (mg/L)
Plasma Micronutrient Levels
Time frame: out to 90 days
Vitamin B1 (mg/L)
Plasma Micronutrient Levels
Time frame: out to 90 days
Vitamin B2 (mg/L)
Plasma Micronutrient Levels
Time frame: out to 90 days
Vitamin B3 (mg/L)
Plasma Micronutrient Levels
Time frame: out to 90 days
Vitamin B6 (mg/L)
Plasma Micronutrient Levels
Time frame: out to 90 days
Vitamin B12 (mg/L)
Plasma Micronutrient Levels
Time frame: out to 90 days
Biotin (mg/L)
Plasma Micronutrient Levels
Time frame: out to 90 days
Folate (mg/L)
Plasma Micronutrient Levels
Time frame: out to 90 days
Pantothenate (mg/L)
Plasma Micronutrient Levels
Time frame: out to 90 days
Vitamin C (mg/L)
Plasma Micronutrient Levels
Time frame: out to 90 days
Vitamin D3 (mg/L)
Plasma Micronutrient Levels
Time frame: out to 90 days
Vitamin K2 (mg/L)
Plasma Micronutrient Levels
Time frame: out to 90 days
Magnesium (mg/L)
Plasma Micronutrient Levels
Time frame: out to 90 days
Manganese (mg/L)
Plasma Micronutrient Levels
Time frame: out to 90 days
Zinc (mg/L)
Plasma Micronutrient Levels
Time frame: out to 90 days
Copper (mg/L)
Plasma Micronutrient Levels
Time frame: out to 90 days
Alpha Lipoic Acid (mg/L)
Plasma Micronutrient Levels
Time frame: out to 90 days
Glutamine (mg/L)
Plasma Micronutrient Levels
Time frame: out to 90 days
Glutathione (mg/L)
Plasma Micronutrient Levels
Time frame: out to 90 days
Carnitine (mg/L)
Plasma Micronutrient Levels
Time frame: out to 90 days
Choline (mg/L)
Plasma Micronutrient Levels
Time frame: out to 90 days
Inositol (mg/L)
Plasma Micronutrient Levels
Time frame: out to 90 days
Coenzyme Q10 (mg/L)
Plasma Micronutrient Levels
Time frame: 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.
Time frame: up to 90 days
Plan to share: No — IPD will not be shared with researchers outside the study team.
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.