search
Back to results

Differences in Postprandial Glucose Changes

Primary Purpose

Diabetes Mellitus, Type II, Overweight or Obesity

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Shake 1 then Shake 2
Shake 2 then Shake 1
Sponsored by
The University of The West Indies
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Diabetes Mellitus, Type II

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: A diagnosis of T2DM for any length of time, last HbA1C (within the last 6 months) of < / = 8% Exclusion Criteria: 1. On insulin for any length of time

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Shake 1 then Shake 2

    Shake 2 then Shake 1

    Arm Description

    Participants will consume 1 bottle of shake 1 and take their normal morning medications. After this 3ml blood samples will be taken via the cannula at 30mins, 60mins and 120 mins post meal. During the waiting period between phlebotomy, a sensory analysis questionnaire which asks participants to rate the taste, appearance, texture and smell of the product. After a 1-week washout period, the entire protocol will be repeated using Shake 2.

    Participants will consume 1 bottle of Shake 2 and take their normal morning medications. After this 3ml blood samples will be taken via the cannula at 30mins, 60mins and 120 mins post meal. During the waiting period between phlebotomy, a sensory analysis questionnaire which asks participants to rate the taste, appearance, texture and smell of the product. After a 1-week washout period, the entire protocol will be repeated using Shake 1.

    Outcomes

    Primary Outcome Measures

    Change in plasma glucose concentration post oral intake of shake

    Secondary Outcome Measures

    Sensory analysis of taste, texture, smell and appearance of shakes
    measured on a 5-point hedonic scale

    Full Information

    First Posted
    July 5, 2023
    Last Updated
    July 13, 2023
    Sponsor
    The University of The West Indies
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05957224
    Brief Title
    Differences in Postprandial Glucose Changes
    Official Title
    An Intervention Comparing Changes in the Plasma Glucose Profile Over a Three-hour Timespan in Persons With T2DM Following Caribbean Shake vs Glucerna Intake: A Double Blinded, Cross-over Design
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 15, 2023 (Anticipated)
    Primary Completion Date
    May 15, 2024 (Anticipated)
    Study Completion Date
    November 15, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    The University of The West Indies

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Following a meal, in nondiabetic individuals, blood glucose rises to peak at 1hr and returns to baseline in 2 - 3 hours. In T2DM, this peak is higher and prolonged. Meal plans for persons with T2DM should comprise evenly spaced, complex carbohydrate portions in order to avoid post-prandial glucose spikes. Researchers have developed an expanded line of Caribbean-flavoured, low-calorie meal-replacement shakes which have been formulated to match the macronutrient and caloric content of a commercially available brand. In this trial investigators aim to (1) examine the change in glucose levels post intake of Caribbean vs the commercially available brand and (2) to conduct a comparative sensory analysis of the two shakes.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diabetes Mellitus, Type II, Overweight or Obesity

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Model Description
    There is a one-week washout period between intake of the two shakes.
    Masking
    ParticipantOutcomes Assessor
    Masking Description
    The participants will be blinded to the intervention as the shakes will be given in unmarked containers - however as the flavours are very different it is likely that participants will be able to tell them apart. Data analysts will be blinded.
    Allocation
    Randomized
    Enrollment
    25 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Shake 1 then Shake 2
    Arm Type
    Experimental
    Arm Description
    Participants will consume 1 bottle of shake 1 and take their normal morning medications. After this 3ml blood samples will be taken via the cannula at 30mins, 60mins and 120 mins post meal. During the waiting period between phlebotomy, a sensory analysis questionnaire which asks participants to rate the taste, appearance, texture and smell of the product. After a 1-week washout period, the entire protocol will be repeated using Shake 2.
    Arm Title
    Shake 2 then Shake 1
    Arm Type
    Experimental
    Arm Description
    Participants will consume 1 bottle of Shake 2 and take their normal morning medications. After this 3ml blood samples will be taken via the cannula at 30mins, 60mins and 120 mins post meal. During the waiting period between phlebotomy, a sensory analysis questionnaire which asks participants to rate the taste, appearance, texture and smell of the product. After a 1-week washout period, the entire protocol will be repeated using Shake 1.
    Intervention Type
    Other
    Intervention Name(s)
    Shake 1 then Shake 2
    Intervention Description
    Oral administration of Caribbean low-calorie meal-replacement shake then commercial low-calorie meal-replacement shake
    Intervention Type
    Other
    Intervention Name(s)
    Shake 2 then Shake 1
    Intervention Description
    Oral administration of commercial low-calorie meal-replacement shake then Caribbean low-calorie meal-replacement shake
    Primary Outcome Measure Information:
    Title
    Change in plasma glucose concentration post oral intake of shake
    Time Frame
    30 minutes, 60 minutes and 120 minutes post oral intake of shake
    Secondary Outcome Measure Information:
    Title
    Sensory analysis of taste, texture, smell and appearance of shakes
    Description
    measured on a 5-point hedonic scale
    Time Frame
    within 1hour post oral intake of shake

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: A diagnosis of T2DM for any length of time, last HbA1C (within the last 6 months) of < / = 8% Exclusion Criteria: 1. On insulin for any length of time

    12. IPD Sharing Statement

    Learn more about this trial

    Differences in Postprandial Glucose Changes

    We'll reach out to this number within 24 hrs