Diabetes Mellitus, Type IINCT05957224
Differences in Postprandial Glucose Changes
A study testing Shake 1 then Shake 2 and Shake 2 then Shake 1 in people with Diabetes Mellitus, Type II and Overweight or Obesity, run by The University of The West Indies.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetes Mellitus, Type II, Overweight or Obesity
- What is being tested?
- Shake 1 then Shake 2 and Shake 2 then Shake 1
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- 15 Nov 2023to 15 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A diagnosis of T2DM for any length of time,
- last HbA1C (within the last 6 months) of < / = 8%
Who cannot join
- 1. On insulin for any length of time
About this study
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
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
- Being tested
- Shake 1 then Shake 2, Shake 2 then Shake 1
- Medical subject headings
- Diabetes Mellitus, Type 2, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shake 1 then Shake 2Other
Oral administration of Caribbean low-calorie meal-replacement shake then commercial low-calorie meal-replacement shake
Shake 2 then Shake 1Other
Oral administration of commercial low-calorie meal-replacement shake then Caribbean low-calorie meal-replacement shake
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Shake 2 then Shake 1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in plasma glucose concentration post oral intake of shake
Measured: 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
measured on a 5-point hedonic scale
Measured: within 1hour post oral intake of shake
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2023
- Study start15 Nov 2023 (estimated)
- Primary completion15 May 2024 (estimated)
- Study completion15 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type IIStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- There is a one-week washout period between intake of the two shakes.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of The West Indies
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05957224
- Sponsor's protocol ID
- SHIFT
- Status last verified
- Jul 2023
- First submitted
- 5 Jul 2023
- Last updated
- 24 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05957224
- Acronym / sponsor ID
- SHIFT
- Conditions
- Diabetes Mellitus, Type II, Overweight or Obesity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- The University of The West IndiesUniversity, hospital or other
- Study start
- 15 Nov 2023 (estimated)
- Primary completion
- 15 May 2024 (estimated)
- Study completion
- 15 Nov 2024 (estimated)
- First posted
- 24 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- There is a one-week washout period between intake of the two shakes.
| Arm | Type | Receives |
|---|---|---|
| Shake 1 then Shake 2 | Experimental | Other: Shake 1 then Shake 2Participants 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. |
| Shake 2 then Shake 1 | Experimental | Other: Shake 2 then Shake 1Participants 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- A diagnosis of T2DM for any length of time,
- last HbA1C (within the last 6 months) of < / = 8%
Key exclusion criteria (1 listed)
- 1. On insulin for any length of time
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shake 1 then Shake 2Oral administration of Caribbean low-calorie meal-replacement shake then commercial low-calorie meal-replacement shake | Other | Shake 1 then Shake 2 |
| Shake 2 then Shake 1Oral administration of commercial low-calorie meal-replacement shake then Caribbean low-calorie meal-replacement shake | Other | Shake 2 then Shake 1 |
Primary outcome
Change in plasma glucose concentration post oral intake of shake
Time frame: 30 minutes, 60 minutes and 120 minutes post oral intake of shake
1 secondary outcome
Sensory analysis of taste, texture, smell and appearance of shakes
Time frame: within 1hour post oral intake of shake
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Shake 1 then Shake 2 and Shake 2 then Shake 1 in people with Diabetes Mellitus, Type II and Overweight or Obesity, run by The University of The West Indies.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in plasma glucose concentration post oral intake of shake (time frame: 30 minutes, 60 minutes and 120 minutes post oral intake of shake). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2023.