Brief 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 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.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

participants targeted

Target at P50-P75 for not_applicable

Timeline

Completed

Started Sep 2021

Typical duration for not_applicable

Geographic Reach

1 country

2 active sites

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.3 years study duration

First Submitted

Initial submission to the registry

November 12, 2020

Completed

12 days until next milestone

First Posted

Study publicly available on registry

November 24, 2020

Completed

9 months until next milestone

Study Start

First participant enrolled

September 3, 2021

Completed

2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 21, 2023

Completed

3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2023

Completed

Last Updated

May 17, 2023

Status Verified

May 1, 2023

Enrollment Period

2 years

First QC Date

November 12, 2020

Last Update Submit

May 16, 2023

Conditions

Aging Age-related Cognitive Decline

Keywords

Dietary SupplementAgingSafetyTolerability

Outcome Measures

Primary Outcomes (33)

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.
out to 90 days
Hematocrit (%)
Safety Assessment in Hematology
out to 90 days
Hemoglobin (g/L)
Safety Assessment in Hematology
out to 90 days
Erythrocytes (10^12/L)
Safety Assessment in Hematology
out to 90 days
Leukocytes (10^9/L)
Safety Assessment in Hematology
out to 90 days
Basophils (10^3/uL)
Safety Assessment in Hematology
out to 90 days
Basophils/Leukocytes (%)
Safety Assessment in Hematology
out to 90 days
Eosinophils (10^9/L)
Safety Assessment in Hematology
out to 90 days
Eosinophils/Leukocytes (%)
Safety Assessment in Hematology
out to 90 days
Lymphocytes (10^9/L)
Safety Assessment in Hematology
out to 90 days
Lymphocytes/Leukocytes (%)
Safety Assessment in Hematology
out to 90 days
Monocytes (10^9/L)
Safety Assessment in Hematology
out to 90 days
Monocytes/Leukocytes (%)
Safety Assessment in Hematology
out to 90 days
Neutrophils (10^9/L)
Safety Assessment in Hematology
out to 90 days
Neutrophils/Leukocytes (%)
Safety Assessment in Hematology
out to 90 days
Platelet Count (10^9/L)
Safety Assessment in Hematology
out to 90 days
Serum Glucose (mmol/L)
Safety Assessment in Serum Chemistry
out to 90 days
Sodium (mmol/L)
Safety Assessment in Serum Chemistry
out to 90 days
Potassium (mmol/L)
Safety Assessment in Serum Chemistry
out to 90 days
Calcium (mmol/L)
Safety Assessment in Serum Chemistry
out to 90 days
Chloride (mmol/L)
Safety Assessment in Serum Chemistry
out to 90 days
Urea (mmol/L)
Safety Assessment in Serum Chemistry
out to 90 days
Creatinine (umol/L)
Safety Assessment in Serum Chemistry
out to 90 days
Urate (umol/L)
Safety Assessment in Serum Chemistry
out to 90 days
Albumin (g/L)
Safety Assessment in Serum Chemistry
out to 90 days
Alkaline Phosphatase (U/L)
Safety Assessment in Serum Chemistry
out to 90 days
Aspartate Phosphatase (U/L)
Safety Assessment in Serum Chemistry
out to 90 days
Alanine Transaminase (U/L)
Safety Assessment in Serum Chemistry
out to 90 days
Gamma Glutamyl Transpeptidase (U/L)
Safety Assessment in Serum Chemistry
out to 90 days
Total Bilirubin (umol/L)
Safety Assessment in Serum Chemistry
out to 90 days
Direct Bilirubin (umol/L)
Safety Assessment in Serum Chemistry
out to 90 days
Lactate Dehydrogenase (U/L)
Safety Assessment in Serum Chemistry
out to 90 days
High Sensitivity C-Reactive Protein (mg/L)
Safety Assessment in Serum Chemistry
out to 90 days

Secondary Outcomes (24)

Vitamin A (mg/L)
out to 90 days
Vitamin B1 (mg/L)
out to 90 days
Vitamin B2 (mg/L)
out to 90 days
Vitamin B3 (mg/L)
out to 90 days
Vitamin B6 (mg/L)
out to 90 days
+19 more secondary outcomes

Study Arms (3)

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.

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.

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.

Dietary Supplement: Multi-target Dietary Supplement (MTDS)

Interventions

Multi-target Dietary Supplement (MTDS)DIETARY_SUPPLEMENT

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

100 RDD60 RDD80 RDD

Eligibility Criteria

Age45 Years - 85 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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
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:
+5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Douglas Borehamlead
McMaster Universitycollaborator

Study Sites (2)

Northern Ontario School of Medicine - Elliot Lake site

Elliot Lake, Ontario, P5A 1X2, Canada

Location

McMaster University - Behavioural Neurosciences

Hamilton, Ontario, L8S 4K1, Canada

Location

Study Officials

Douglas Boreham, PhD
Northern Ontario School of Medicine
PRINCIPAL INVESTIGATOR

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: SPONSOR INVESTIGATOR
PI Title: Professor/Director - Medical Sciences

Study Record Dates

First Submitted

November 12, 2020

First Posted

November 24, 2020

Study Start

September 3, 2021

Primary Completion

September 21, 2023

Study Completion

December 15, 2023

Last Updated

May 17, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing: Will not share

Locations

CA(2)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (33)

Secondary Outcomes (24)

Study Arms (3)

100 RDD

80 RDD

60 RDD

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (2)

Study Officials

Study Design

Study Record Dates

Data Sharing

Locations