Non-DiabeticNCT05314036
The Wellness Transformation Network Pilot Study
A study testing Standardized test meal in people with Non-Diabetic and Females Who Are Not Pregnant or Breast Feeding, run by SciMar Ltd. at 1 site in Canada.
Trial summary
The purpose of the study is to establish a Standard Operating Procedure (SOP) for the screening of pathologies associated with prediabetes and type 2 diabetes. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Non-Diabetic, Females Who Are Not Pregnant or Breast Feeding
- What is being tested?
- Standardized test meal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteCanada
- Study dates
- 17 Jan 2022to 5 Apr 2022
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults (males and females)18 years of age or older.
- Able to understand and communicate in English.
- Willing to answer a questionnaire on lifestyle and health status.
- Willing to undergo measurements of height, weight, waist circumference, hip circumference, blood pressure, heart rate and heart rate variability, body mass index, handgrip strength (handgrip dynamometry) testing, and pulmonary function (spirometry) testing.
- Willing to fast for 12 hours prior to two in-person study visits.
- Willing to consume a standardized test meal containing food ingredients.
Show all 11Show fewer
- Willing to provide a urine sample.
- Willing to take a pregnancy test (female participants of childbearing potential).
- Willing to provide the research team with a listing of all current medications and Natural Health Products(NHPs).
- Willing to complete an online eDiary, including a 3-day food record.
- Willing to give blood samples (finger prick and blood sampling at defined intervals using an intravenous catheter)
Who cannot join
- Individuals diagnosed with diabetes.
- Women with confirmed pregnancy or who are breastfeeding.
- Individuals with allergy or sensitivity to any component of the standardized test meal (i.e., dextrose, lecithin, soy protein).
- Individuals with a fasting blood glucose of 7.0 mmol/L or higher.
- Individuals with abnormal glucose in their urine.
- Individuals who are related to or working for the clinic site, research staff, and study sponsor.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Establishment of a Standard Operating Procedure for Screening of the Pathologies Associated With Prediabetes and Diabetes -The Wellness Transformation Network Pilot Study.
The purpose of the study is to establish a Standard Operating Procedure (SOP) for the screening of pathologies associated with prediabetes and type 2 diabetes.
Read the detailed description
The proposed study will enable screening of pathologies associated with cardiometabolic diseases (i.e., hypertension, prediabetes, insulin resistance, diabetes, and obesity). The Meal-Induced Insulinemia and Glycemia (MIG) score will correlate with those dysfunctions that are components of the Absence of Meal-Induced Insulinemia (AMIS) syndrome. Overall the study aims:
- To establish an SOP for screening pathologies associated with cardiometabolic diseases using a combination of biometrics and metabolomics.
- To compare a participant's MIG score and hepatalin levels following consumption of a standardized test meal containing macronutrients, and the measurement of several indices of organ health associated with diabetes (i.e., body composition, handgrip strength, spirometry, blood pressure, and heart rate variability).
The study will involve 2 study visits: Visit 1 - Screening and Visit 2 - Intervention (Test meal administration and postprandial blood collection).
- Being tested
- Standardized test meal
- Keywords
- Glucose, Insulin, Prediabetes
- Medical subject headings
- Breast Feeding, Insulin Resistance, Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized test mealOther
During this study visit, a standardized test meal will be administered. Blood samples will be collected at baseline and then every 30 minutes for 2 hours after test meal.
| Study group | Role | What they receive |
|---|---|---|
| Acute Postprandial Blood Sampling | Experimental | Two-hour postprandial blood sampling following administration of a standardized test meal Receives: Other: Standardized test meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Establishment of proposed Wellness Transformation Network clinical trial procedures.
Practical feasibility of the proposed Wellness Transformation Network clinical trial procedures (Yes/No)
Measured: 2 Weeks
Secondary outcomes (5)
Time course and curve analysis of serum glucose response after the test meal administration.
Measured: Test: Baseline, every 30 minutes up to 2 hours after test meal administration
Time course and curve analysis of serum insulin response after the test meal administration.
Measured: Test: Baseline, every 30 minutes up to 2 hours after test meal administration
Time course and curve analysis of serum triglycerides response after the test meal administration.
Measured: Test: Baseline, every 30 minutes up to 2 hours after test meal administration
Time course and curve analysis of plasma hepatalin response after the test meal administration.
Measured: Test: Baseline, every 30 minutes up to 2 hours after test meal administration
Time course and curve analysis of Meal Induced Glycemia (MIG) scores response after the test meal administration.
MIG is calculated using the formula: MIG = (post meal insulin mIU/L X post meal glucose mmol/L) minus (fasted insulin mIU/L X fasted glucose mmol/L). Higher score equates to a worse (unhealthy) outcome.
Measured: Test: Baseline, every 30 minutes up to 2 hours after test meal administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2022
- Study start17 Jan 2022
- Primary completion5 Apr 2022
- Study completion5 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-DiabeticStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- SciMar Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Source Nutraceutical, Inc.
- Responsible party
- Sponsor
- Investigators
- Vanu Ramprasath, PhD, Principal investigator, Source Nutraceutical, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05314036
- Sponsor's protocol ID
- WTN-001
- Status last verified
- Apr 2022
- First submitted
- 10 Feb 2022
- Last updated
- 22 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment of a Standard Operating Procedure for Screening of the Pathologies Associated With Prediabetes and Diabetes -The Wellness Transformation Network Pilot Study.
- ClinicalTrials.gov ID
- NCT05314036
- Acronym / sponsor ID
- WTN-001
- Keywords
- Glucose, Insulin, Prediabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- SciMar Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Source Nutraceutical, Inc.
- Study start
- 17 Jan 2022 (actual)
- Primary completion
- 5 Apr 2022 (actual)
- Study completion
- 5 Apr 2022 (actual)
- First posted
- 6 Apr 2022 (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.
The purpose of the study is to establish a Standard Operating Procedure (SOP) for the screening of pathologies associated with prediabetes and type 2 diabetes.
Detailed description
The proposed study will enable screening of pathologies associated with cardiometabolic diseases (i.e., hypertension, prediabetes, insulin resistance, diabetes, and obesity). The Meal-Induced Insulinemia and Glycemia (MIG) score will correlate with those dysfunctions that are components of the Absence of Meal-Induced Insulinemia (AMIS) syndrome. Overall the study aims:
- To establish an SOP for screening pathologies associated with cardiometabolic diseases using a combination of biometrics and metabolomics.
- To compare a participant's MIG score and hepatalin levels following consumption of a standardized test meal containing macronutrients, and the measurement of several indices of organ health associated with diabetes (i.e., body composition, handgrip strength, spirometry, blood pressure, and heart rate variability).
The study will involve 2 study visits: Visit 1 - Screening and Visit 2 - Intervention (Test meal administration and postprandial blood collection).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acute Postprandial Blood Sampling | Experimental | Other: Standardized test mealTwo-hour postprandial blood sampling following administration of a standardized test meal |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Adults (males and females)18 years of age or older.
- Able to understand and communicate in English.
- Willing to answer a questionnaire on lifestyle and health status.
- Willing to undergo measurements of height, weight, waist circumference, hip circumference, blood pressure, heart rate and heart rate variability, body mass index, handgrip strength (handgrip dynamometry) testing, and pulmonary function (spirometry) testing.
- Willing to fast for 12 hours prior to two in-person study visits.
Key exclusion criteria (6 listed)
- Individuals diagnosed with diabetes.
- Women with confirmed pregnancy or who are breastfeeding.
- Individuals with allergy or sensitivity to any component of the standardized test meal (i.e., dextrose, lecithin, soy protein).
- Individuals with a fasting blood glucose of 7.0 mmol/L or higher.
- Individuals with abnormal glucose in their urine.
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 |
|---|---|---|
| Standardized test mealDuring this study visit, a standardized test meal will be administered. Blood samples will be collected at baseline and then every 30 minutes for 2 hours after test meal. | Other | Acute Postprandial Blood Sampling |
Primary outcome
Establishment of proposed Wellness Transformation Network clinical trial procedures.
Time frame: 2 Weeks
Practical feasibility of the proposed Wellness Transformation Network clinical trial procedures (Yes/No)
5 secondary outcomes
Time course and curve analysis of serum glucose response after the test meal administration.
Time frame: Test: Baseline, every 30 minutes up to 2 hours after test meal administration
Time course and curve analysis of serum insulin response after the test meal administration.
Time frame: Test: Baseline, every 30 minutes up to 2 hours after test meal administration
Time course and curve analysis of serum triglycerides response after the test meal administration.
Time frame: Test: Baseline, every 30 minutes up to 2 hours after test meal administration
Time course and curve analysis of plasma hepatalin response after the test meal administration.
Time frame: Test: Baseline, every 30 minutes up to 2 hours after test meal administration
Time course and curve analysis of Meal Induced Glycemia (MIG) scores response after the test meal administration.
Time frame: Test: Baseline, every 30 minutes up to 2 hours after test meal administration
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 22 Apr 2022.
- Individual participant dataSharing planned: No
Related trials for Non-Diabetic
Active, not recruiting
Evaluation of a Structured Nutrition Educational Program Among Patients With Type 2 Diabetes
Type 2 Diabetes
RecruitingPhase 1
Safety of Cultured Allogeneic Adult Umbilical Cord or Placental Derived Mesenchymal Stem Cell Exosomes for NAION
Eye Diseases, Retinitis Pigmentosa
RecruitingPhase 3
a Prospective, Multicenter, Randomized Controlled Trial, With a Non-randomized Sentinel Cohort, Evaluating the Efficacy of Bioxheal, a Single-layer Placental-derived Biologic in Nonhealing Diabetic Foot Ulcers
Diabetic Foot Ulcer, Amniotic Membrane Placental Allograft
Active, not recruitingObservational study
Wearable NH₃ Sensor for Remote Non-invasive Monitoring and Diagnosis of Diabetic Kidney Disease
Diabetic Nephropathies MeSH:D003928, Diabetes Mellitus, Type 2
RecruitingPhase 2
A Study to Test Whether BI 764524 Helps People With an Eye Condition Called Diabetic Retinopathy
Diabetic Retinopathy
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.
Vanu Ramprasath, PhD principal investigator
Source Nutraceutical, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standardized test meal in people with Non-Diabetic and Females Who Are Not Pregnant or Breast Feeding, run by SciMar Ltd. 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 11 inclusion and 6 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 22 Apr 2022. 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. 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?
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?
Establishment of proposed Wellness Transformation Network clinical trial procedures. (time frame: 2 Weeks). 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 22 Apr 2022.