Differences in Postprandial Glucose Changes

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05957224

Enrollment

Registered

2023-07-24

Start date

2023-11-15

Completion date

2024-11-15

Last updated

2023-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type II, Overweight or Obesity

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.

Interventions

OTHERShake 1 then Shake 2

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

OTHERShake 2 then Shake 1

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

OTHER

Masking

DOUBLE (Subject, Outcomes Assessor)

Masking description

The participants will be blinded to the intervention as the shakes will be given in unmarked containers - however as the flavours are very different it is likely that participants will be able to tell them apart. Data analysts will be blinded.

Intervention model description

There is a one-week washout period between intake of the two shakes.

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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

Design outcomes

Primary

Measure	Time frame
Change in plasma glucose concentration post oral intake of shake	30 minutes, 60 minutes and 120 minutes post oral intake of shake

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026