NCT05314036

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 17, 2022

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

February 10, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 5, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 5, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 6, 2022

Completed
Last Updated

April 22, 2022

Status Verified

April 1, 2022

Enrollment Period

3 months

First QC Date

February 10, 2022

Last Update Submit

April 21, 2022

Conditions

Non-DiabeticFemales Who Are Not Pregnant or Breast Feeding

Keywords

GlucoseInsulinPrediabetes

Outcome Measures

Primary Outcomes (1)

  • Establishment of proposed Wellness Transformation Network clinical trial procedures.

    Practical feasibility of the proposed Wellness Transformation Network clinical trial procedures (Yes/No)

    2 Weeks

Secondary Outcomes (5)

  • Time course and curve analysis of serum glucose response after the test meal administration.

    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.

    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.

    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.

    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.

    Test: Baseline, every 30 minutes up to 2 hours after test meal administration

Study Arms (1)

Acute Postprandial Blood Sampling

EXPERIMENTAL

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

Other: Standardized test meal

Interventions

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.

Acute Postprandial Blood Sampling

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SNI Clinical Research

Winnipeg, Manitoba, R2K 3Z5, Canada

Location

MeSH Terms

Conditions

Breast FeedingInsulin ResistancePrediabetic State

Condition Hierarchy (Ancestors)

Feeding BehaviorBehaviorHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesDiabetes MellitusEndocrine System Diseases

Study Officials

  • Vanu Ramprasath, PhD

    Source Nutraceutical, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2022

First Posted

April 6, 2022

Study Start

January 17, 2022

Primary Completion

April 5, 2022

Study Completion

April 5, 2022

Last Updated

April 22, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)