Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
12 participants
INTERVENTIONAL
2016-06-27
2017-02-06
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
OTHER
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Natural Calm Magnesium
150mg elemental magnesium in a single oral dose
Magnesium
150mg elemental magnesium
Magnesium Bis-glycinate
150mg elemental magnesium in a single oral dose
Magnesium
150mg elemental magnesium
MAGSmart
150mg elemental magnesium in a single oral dose
Magnesium
150mg elemental magnesium
Magnesium citrate
150mg elemental magnesium in a single oral dose
Magnesium
150mg elemental magnesium
Placebo
Placebo
Rice flour
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Magnesium
150mg elemental magnesium
Placebo
Rice flour
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Post-menopausal (greater than 1 year since last menses)
* Healthy as determined by blood chemistry, hematology, urinalysis and past medical history
* BMI 18-27.5 kg/m2
* Normal blood magnesium between 0.65 and 1.05mmol/L
* Normal urinary creatinine clearance 1.18 - 2.18mL/s
* Non-smoker or ex-smoker for greater than 6 months
* Agrees to maintain current dietary and physical activity habits for the duration of the study period except as instructed during run-in periods and on test days
* Willing and able to provide voluntary, written, informed consent
Exclusion Criteria
* Significant cardiac history defined as a history of myocardial infarction (MI); coronary angioplasty or bypass graft(s); valvular disease or repair; unstable angina pectoris; trans ischemic attack (TIA); cerebrovascular accidents (CVA); congestive heart failure; or coronary artery disease (CAD)
* Uncontrolled hypertension defined as untreated systolic blood pressure \> 160 mmHg and/or diastolic blood pressure \> 100 mmHg
* Uncontrolled diabetes defined as fasting blood glucose \> 7 mmol/L
* Treated or untreated thyroid disorders
* History of renal and/or liver disease
* History of clinically significant gastrointestinal pathology (e.g. chronic diarrhea, inflammatory bowel disease) unresolved gastrointestinal symptoms (e. g. diarrhea, vomiting) or other diseases known to interfere with absorption, distribution, metabolism or excretion of the IP or comparators
* History of (in previous 5 years), or currently being treated for cancer (excluding basal cell skin carcinoma)
* Unstable psychiatric disorder
* Acute illness, as judged by the Investigator, within 2 weeks of the first treatment period (Visit 3a)
* Immunocompromised individuals such as participants that have undergone organ transplantation or participants diagnosed with human immunodeficiency virus (HIV)
* History of hemoglobinopathies such as sickle cell anemia or thalassemia, sideroblastic anemia
* Significant abnormal liver function as defined as AST and/or ALT \> 2x the upper limit of normal (ULN), and/or bilirubin \> 2 x the ULN
* Serum creatinine \> 95 umol/L
* Anemia of any etiology defined as hemoglobin \< 110 g/L for females
* Use of anticoagulants, statins, or any other medication for the treatment of hypercholesterolemia and/or hypertension
* Use of prescribed medication or over the counter supplements for weight loss
* Use of acute medication, including antacids, within 72 hours of study supplement dose
* Use of over the counter or prescription products containing magnesium and/or calcium (e.g. multivitamins, calcium carbonate, etc.) within 2 weeks of screening (Visit 1a)
* Use of medications known to interact or interfere with magnesium absorption (See section 3.8.2)
* Use of nicotine-containing products in any form (eg, chewing tobacco, gum, patch) within 30 days of the first test period (Visit 3a)
* Use of caffeine supplements
* Consumption of more than 50g of chocolate per day
* Excessive consumption of caffeinated beverages (e.g. \>2 cups of any combination of tea, coffee, energy drinks, caffeinated soda, etc. per day) or participants who experience caffeine withdrawal headaches
* Allergy or sensitivity to study supplement ingredients
* Food allergies or sensitivities to any of the foods outlined in Appendix 2.
* Vegan or vegetarian
* Recent change in weight (up or down more than 10 % of usual body weight, within the past year)
* Participants who work, evening or night shifts
* Donation or loss of whole blood prior to the administration of the study product as follows: 50-300 mL of whole blood within 30 days, 301-500 mL of whole blood within 45 days or more than 500 mL within 56 days prior to the administration of the IP or comparators
* Presence or history (past 6 months) of alcohol or drug abuse; alcohol use of \>2 standard alcoholic drinks per day
* Participant is unwilling or unable to abide by the requirements of the protocol
* Any condition that would interfere with the participant's ability to comply with study instructions, might confound the interpretation of the study, or put the participant at risk
* Participant has taken an investigational medicine or has participated in a research study within 30 days prior to the run-in period (Visit 2a)
35 Years
65 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
NETWORK
Natural Calm Canada
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Anthony Bier, MD
Role: PRINCIPAL_INVESTIGATOR
Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Nutrasource
Guelph, Ontario, Canada
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
TOPN-1501
Identifier Type: -
Identifier Source: org_study_id