Differences in Postprandial Glucose Changes

July 13, 2023 updated by: The University of The West Indies

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

25

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. A diagnosis of T2DM for any length of time,
  2. last HbA1C (within the last 6 months) of < / = 8%

Exclusion Criteria:

1. On insulin for any length of time

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Shake 1 then Shake 2
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.
Other: Shake 1 then Shake 2
Oral administration of Caribbean low-calorie meal-replacement shake then commercial low-calorie meal-replacement shake
Experimental: Shake 2 then Shake 1
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.
Other: Shake 2 then Shake 1
Oral administration of commercial low-calorie meal-replacement shake then Caribbean low-calorie meal-replacement shake

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in plasma glucose concentration post oral intake of shake
Time Frame: 30 minutes, 60 minutes and 120 minutes post oral intake of shake
30 minutes, 60 minutes and 120 minutes post oral intake of shake

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensory analysis of taste, texture, smell and appearance of shakes
Time Frame: within 1hour post oral intake of shake
measured on a 5-point hedonic scale
within 1hour post oral intake of shake

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of The West Indies

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 15, 2023

Primary Completion (Estimated)

May 15, 2024

Study Completion (Estimated)

November 15, 2024

Study Registration Dates

First Submitted

July 5, 2023

First Submitted That Met QC Criteria

July 13, 2023

First Posted (Estimated)

July 24, 2023

Study Record Updates

Last Update Posted (Estimated)

July 24, 2023

Last Update Submitted That Met QC Criteria

July 13, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHIFT

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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