Differences in Postprandial Glucose Changes

NCT ID: NCT05957224

Last Updated: 2023-07-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-15
• Study Completion Date: 2024-11-15

Brief 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.

Conditions

Diabetes Mellitus, Type II; Overweight or Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Shake 1 then Shake 2

Intervention Type: OTHER

Oral administration of Caribbean low-calorie meal-replacement shake then commercial low-calorie meal-replacement shake

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.

Group Type: EXPERIMENTAL

Shake 2 then Shake 1

Intervention Type: OTHER

Oral administration of commercial low-calorie meal-replacement shake then Caribbean low-calorie meal-replacement shake

Interventions

Shake 1 then Shake 2

Oral administration of Caribbean low-calorie meal-replacement shake then commercial low-calorie meal-replacement shake

Intervention Type: OTHER

Shake 2 then Shake 1

Oral administration of commercial low-calorie meal-replacement shake then Caribbean low-calorie meal-replacement shake

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The University of The West Indies

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

SHIFT

Identifier Type: -

Identifier Source: org_study_id