Differences in Postprandial Glucose Changes

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Diabetes Mellitus, Type II, Overweight or Obesity

Intervention / Treatment
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* Other: Shake 1 then Shake 2
* Other: Shake 2 then Shake 1


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: There is a one-week washout period between intake of the two shakes.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Shake 1 then Shake 2<br>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<br>* Oral administration of Caribbean low-calorie meal-replacement shake then commercial low-calorie meal-replacement shake<br>|
| Experimental: Shake 2 then Shake 1<br>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<br>* Oral administration of commercial low-calorie meal-replacement shake then Caribbean low-calorie meal-replacement shake<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in plasma glucose concentration 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 | measured on a 5-point hedonic scale | within 1hour post oral intake of shake |