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
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Diabetes Mellitus, Type II
• Overweight
• Overweight or Obesity

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