Differences in Postprandial Glucose Changes

Sponsor

The University of The West Indies (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05957224

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type II Overweight or Obesity	Other: Shake 1 then Shake 2 Other: Shake 2 then Shake 1	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

25 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

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

Masking:

Double (Participant, 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.

Primary Purpose:

Other

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

Anticipated Study Start Date :

Nov 15, 2023

Anticipated Primary Completion Date :

May 15, 2024

Anticipated Study Completion Date :

Nov 15, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Other: Shake 1 then Shake 2 Oral administration of Caribbean low-calorie meal-replacement shake then commercial low-calorie meal-replacement shake
Experimental: 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.	Other: Shake 2 then Shake 1 Oral administration of commercial low-calorie meal-replacement shake then Caribbean low-calorie meal-replacement shake

Arm

Intervention/Treatment

Experimental: 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.

Other: Shake 1 then Shake 2

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

Experimental: 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.

Other: Shake 2 then Shake 1

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

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

A diagnosis of T2DM for any length of time,
last HbA1C (within the last 6 months) of < / = 8%

Exclusion Criteria:

On insulin for any length of time

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

The University of The West Indies

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

The University of The West Indies

ClinicalTrials.gov Identifier:

NCT05957224

Other Study ID Numbers:

SHIFT

First Posted:

Jul 24, 2023

Last Update Posted:

Jul 24, 2023

Last Verified:

Jul 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Overweight

Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Jul 24, 2023