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NCT05957224 Clinical Trial

Differences in Postprandial Glucose Changes

Overweight or Obesity Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05957224
Other study ID # SHIFT
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date November 15, 2023
Est. completion date November 15, 2024

Study information
Verified date July 2023
Source The University of The West Indies
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 25
Est. completion date November 15, 2024
Est. primary completion date May 15, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Other:
• Shake 1 then Shake 2
Oral administration of Caribbean low-calorie meal-replacement shake then commercial low-calorie meal-replacement shake
• Shake 2 then Shake 1
Oral administration of commercial low-calorie meal-replacement shake then Caribbean low-calorie meal-replacement shake

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
The University of The West Indies

Outcome
Type Measure Description Time frame Safety issue
Primary Change in plasma glucose concentration post oral intake of shake 30 minutes, 60 minutes and 120 minutes post oral intake of shake
Secondary Sensory analysis of taste, texture, smell and appearance of shakes measured on a 5-point hedonic scale within 1hour post oral intake of shake
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