Differences in Postprandial Glucose Changes

NCT05957224 | Unknown

• 1 other identifier: SHIFT
• Study Type: interventional
• Target: 25
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Change in plasma glucose concentration post oral intake of shake

  30 minutes, 60 minutes and 120 minutes post oral intake of shake

Secondary Outcomes (1)

• Sensory analysis of taste, texture, smell and appearance of shakes

  within 1hour post oral intake of shake

Study Arms (2)

Shake 1 then Shake 2

EXPERIMENTAL

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

Shake 2 then Shake 1

EXPERIMENTAL

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

Interventions

Shake 1 then Shake 2 OTHER

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

Shake 1 then Shake 2

Shake 2 then Shake 1 OTHER

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

Shake 2 then Shake 1

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \. On insulin for any length of time

Sponsors & Collaborators

• The University of The West Indies: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Overweight; Obesity

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: July 5, 2023
• First Posted: July 24, 2023
• Study Start: November 15, 2023
• Primary Completion: May 15, 2024
• Study Completion: November 15, 2024
• Last Updated: July 24, 2023

Record last verified: 2023-07