The Wellness Transformation Network Pilot Study

NCT ID: NCT05314036

Last Updated: 2022-04-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-17
• Study Completion Date: 2022-04-05

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 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:

1. To establish an SOP for screening pathologies associated with cardiometabolic diseases using a combination of biometrics and metabolomics.

2. 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).

Conditions

Non-Diabetic; Females Who Are Not Pregnant or Breast Feeding

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Acute Postprandial Blood Sampling

Two-hour postprandial blood sampling following administration of a standardized test meal

Group Type: EXPERIMENTAL

Standardized test meal

Intervention Type: OTHER

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.

Interventions

Standardized test meal

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Source Nutraceutical, Inc.

INDUSTRY

Sponsor Role: collaborator

SciMar Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vanu Ramprasath, PhD

Role: PRINCIPAL_INVESTIGATOR

Source Nutraceutical, Inc.

Locations

SNI Clinical Research

Winnipeg, Manitoba, Canada

Countries

Canada

Other Identifiers

WTN-001

Identifier Type: -

Identifier Source: org_study_id