Differences in Postprandial Glucose Changes

Not Applicable

Not yet recruiting

• Conditions: Diabetes Mellitus, Type II; Overweight or Obesity
• Interventions: Other: Shake 2 then Shake 1; Other: Shake 1 then Shake 2

• Registration Number: NCT05957224
• Lead Sponsor: The University of The West Indies

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-07
• Study First Submitted: 2023-07-05
• Study First Submitted QC: 2023-07-13
• Last Update Submitted: 2023-07-13
• Study First Posted: 2023-07-24
• Last Update Posted: 2023-07-24
• Study Start: 2023-11-15
• Primary Completion: 2024-05-15
• Study Completion: 2024-11-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 25

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Shake 2 then Shake 1	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.
Shake 1 then Shake 2	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Sensory analysis of taste, texture, smell and appearance of shakes	within 1hour post oral intake of shake	measured on a 5-point hedonic scale