Differences in Postprandial Glucose Changes

The University of The West Indies

Status: Not yet enrolling

Conditions: Diabetes Mellitus, Type II; Overweight or Obesity

Treatments: Other: Shake 2 then Shake 1; Other: Shake 1 then Shake 2

Study type: Interventional

Funder types: Other

Identifiers

NCT05957224

SHIFT

Details and patient eligibility

About

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.

Enrollment: 25 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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25 participants in 2 patient groups

Shake 1 then Shake 2

Experimental group

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.

Treatment:

Other: Shake 1 then Shake 2

Shake 2 then Shake 1

Experimental group

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.

Treatment:

Other: Shake 2 then Shake 1