Status:
COMPLETED
The Wellness Transformation Network Pilot Study
Lead Sponsor:
SciMar Ltd.
Collaborating Sponsors:
Source Nutraceutical, Inc.
Conditions:
Non-Diabetic
Females Who Are Not Pregnant or Breast Feeding
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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.
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 Insuline...
Eligibility Criteria
Inclusion
- 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.
- 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)
Exclusion
- 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.
Key Trial Info
Start Date :
January 17 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 5 2022
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT05314036
Start Date
January 17 2022
End Date
April 5 2022
Last Update
April 22 2022
Active Locations (1)
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1
SNI Clinical Research
Winnipeg, Manitoba, Canada, R2K 3Z5