Glycaemic Response in Healthy ParticipantsNCT05353712
Effect of Consuming Products Containing Rare Sugars Alongside Sucrose on Glycaemic Response in Healthy Adults
A study testing SUCROSE, ARA20 and ARA40 in people with Glycaemic Response in Healthy Participants, run by University of Nottingham at 2 sites in United Kingdom.
Trial summary
Food manufacturers are being tasked to reduce the added sugar content of products. Rare, but natural sugars, may serve as useful sweeteners as they are low-calorie, safe, sweet and have a mild taste. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Glycaemic Response in Healthy Participants
- What is being tested?
- SUCROSE, ARA20 and ARA40
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- May 2022to Nov 2022
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adults of any gender and any sociodemographic background, who are capable of giving informed consent.
- Aged 18 years or over (no upper age limit).
- Able to understand spoken and written English well enough to understand the consent forms and information sheets, and to give responses to questionnaires.
Who cannot join
- Diagnosed hyperglycaemia, insulin resistance, diabetes or high blood pressure.
- Allergy, intolerance, sensitivity or dietary restriction that would prevent the consumption of the sweet crème samples.
- Anxiety/phobias that would prevent the sampling of venous blood.
Trial locations and contacts
2 sites in 1 country.
Alison Smith, MSc contact
United Kingdom2 sites
University of Nottingham
Loughborough, Leicestershire, LE12 5RD
Preeti Jethwa, Preeti.Jethwa@nottingham.ac.uk
Alison Smith, Alison.Smith1@nottingham.ac.uk
Clinical Research Facility, Medical School, University of Nottingham
Nottingham, Nottinghamshire, NG7 2UH
Rebecca Nicol, Rebecca.Nicol2@nuh.nhs.uk
About this study
Food manufacturers are being tasked to reduce the added sugar content of products. Rare, but natural sugars, may serve as useful sweeteners as they are low-calorie, safe, sweet and have a mild taste. Previous studies have shown that consuming rare sugars alongside other carbohydrates leads to a lower spike in blood glucose after eating. This means that products containing rare sugars may provide health benefits. However, most studies use rare sugars in a glucose drink, so the effect of consuming rare sugars in foods is not known.
The aim of this study is to find out whether consuming sweet crème products containing rare sugars reduces the blood glucose response compared to sucrose-only products. The effect of the rare sugar products on hunger and appetite will also be assessed.
Participants will attend the Clinical Research Facility on 6 occasions, after fasting for 10 hours. At each visit, they will consume a different sample of sweet crème. They will be asked to give blood samples before eating the sample, and at regular intervals for 2 hours afterwards. They will also complete questionnaires to assess their appetite using linear scales. Blood samples will be analysed in the laboratory to measure the level of glucose and insulin at each time point. The changes in blood glucose and insulin after consuming the different samples will be compared to find out if the samples containing rare sugars reduced the response.
Read the detailed description
Main Hypotheses:
This study is designed to test two main hypotheses:
- Sweet crème products containing the rare sugars arabinose or tagatose will cause a lower spike in blood glucose and insulin than sucrose-only products.
- Sweet crème products containing the rare sugars arabinose or tagatose will be no less satiating than sucrose-only products.
The null hypotheses are therefore:
- Levels of blood glucose and insulin are not significantly different after consuming sweet crème products containing rare sugars compared to sucrose-only products.
- Appetite and food intake are significantly higher after consuming sweet crème products containing rare sugars compared to sucrose-only products.
Study Overview:
This study will be a double-blind crossover trial, allowing each participant to act as their own control. Twenty participants will be recruited and fully informed about the study before giving informed consent. Eligible participants will attend the Clinical Research Facility on 6 separate mornings following an overnight fast. On each occasion participants will consume 40-50g of sweet crème served with commercially available sweet wafers. Sweet crème samples will contain vegetable fat and sucrose with or without the addition of D-tagatose or L-arabinose. Neither the participants or the researchers administering the tests will be aware of which sample is being consumed at each visit. Blood samples will be taken before consumption and at regular intervals for 120 minutes afterwards. Blood samples will be analysed to measure plasma glucose, insulin, and the appetite-regulating hormones GLP-1 and GIP. During each visit participants will also be asked to complete questionnaires assessing their hunger and desire to eat, and any gastrointestinal symptoms.
Samples:
Six different sweet crème samples will be included as listed below:
SUC- Full-sucrose sample (2.5:1 sucrose:vegetable fat)
CONTROL- Reduced-sucrose sample (1.5:1 sucrose:fat)
ARA20- Low-dose arabinose sample (1.5:1:0.5 sucrose:fat:arabinose)
ARA40- High-dose arabinose sample (1.5:1:1 sucrose:fat:arabinose)
TAG20- Low-dose tagatose sample (1.5:1:0.5 sucrose:fat:tagatose)
TAG40- High-dose tagatose sample (1.5:1:1 sucrose:fat:tagatose)
Using these samples, we will be able to investigate the effect of adding rare sugars to a constant sucrose/fat load (by comparing each experimental product with the control product), and also to investigate the effect of replacing sucrose with rare sugars (by comparing ARA40 and TAG40 products with the SUC product).
Study visits:
Each participant will visit on 6 occasions and consume one of the six samples on each visit in a randomised order.
Visits will be separated by at least one week, so each participant is expected to be involved in the study for 2-3 months from start to finish. A randomised crossover design has been selected so that each participant can act as their own control, which reduces the impact of variation in glycaemic response between individuals. The crossover design will therefore allow us to detect significant differences with a smaller number of participants.
At each clinic visit we will measure the glycaemic response (increase in blood glucose and insulin), using methods similar to the standard methodology for assessing glycaemic index. We will also evaluate the effect of the samples on hunger and desire to eat, and gastrointestinal symptoms, using adapted validated questionnaires.
The procedures for each clinic visit are summarised below:
- Pre-visit fast: Participants will fast for 10 hours before visit. All visits will be scheduled before 10am.
- Clinic visits: Participants will visit the clinic on 6 occasions, separated by at least one week. Each visit will last around 3 hours. Every effort will be made to ensure participants are comfortable during clinic visits. Participants will be seated comfortably throughout, and will be asked to remain seated as much as possible. They will be allowed to read or use laptops/phones, and toilet visits will be permitted.
- Health questionnaire: An initial health questionnaire will ask for details of BMI, smoking, alcohol consumption, habitual exercise and gastrointestinal symptoms. Questionnaires on subsequent visits will assess gastrointestinal symptoms only.
- Blood sampling: Research nurses at the CRF will insert cannula in a vein in the hand. Blood will be sampled at baseline and at 15, 30, 45, 60, 90 and 120 minutes after consumption of the sample.
- Consumption of product and sensory question: Researchers will ask participants to consume a sample consisting of 40-50g sweet crème served with commercially available wafers. They will be asked to rate their liking of the product on a 9-point hedonic scale. The quantity and composition of the samples has been carefully considered to ensure that they will cause a sufficient glycaemic response for us to be able to detect significant differences between samples. The composition is similar to typical sweet crème products (eg the centre of an Oreo biscuit), and it will be served with ice cream wafers to increase the palatability for participants. Participants will be asked to rate their liking of each sample immediately after consuming it using a hedonic scale. Neither the participant nor the researcher administering the clinic visit will be aware of which sample is being consumed at each visit.
- Appetite questionnaires: Researchers will administer paper-based questionnaires using visual analogue scores to ask participants how hungry/full they feel and their desire to eat certain foods. In order to capture changes in appetite over the clinic visit, participants will be asked to complete the same questionnaire at baseline and at 35, 65 and 125 minutes after consuming the product.
- Buffet meal: After the 120 minute blood sampling, cannulas will be removed and participants will be offered a buffet meal consisting of a range of sweet and savoury foods, served with water. Researchers will record the food intake of each participant.
- 24 hour food diary: Participants will be asked to record their food intake for the rest of the day (until midnight on the day of the study visit) on a paper-based food diary.
- Being tested
- SUCROSE, CONTROL, ARA20, ARA40, TAG20
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SUCROSEOther
50g sweet creme composed of 14.3g vegetable fat and 35.7g sucrose.
CONTROLOther
35.7g sweet creme composed of 14.3g vegetable fat and 21.4g sucrose.
ARA20Other
42.9g sweet creme composed of 14.3g vegetable fat, 21.4g sucrose and 7.1g L-arabinose
ARA40Other
50g sweet creme composed of 14.3g vegetable fat, 21.4g sucrose and 14.3g L-arabinose
TAG20Other
42.9g sweet creme composed of 14.3g vegetable fat, 21.4g sucrose and 7.1g D-tagatose
TAG40Other
50g sweet creme composed of 14.3g vegetable fat, 21.4g sucrose and 14.3g L-arabinose
| Study group | Role | What they receive |
|---|---|---|
| Group T: ABCDEF | Experimental | Participants will receive all six blind-coded samples, in the order A, B, C, D, E, F. There will be a minimum of 7 days washout between samples. Receives: Other: SUCROSE; Other: CONTROL; Other: ARA20; Other: ARA40; Other: TAG20; Other: TAG40 |
| Group V: FABCDE | Experimental | Participants will receive all six blind-coded samples, in the order F, A, B, C, D, E. There will be a minimum of 7 days washout between samples. Receives: Other: SUCROSE; Other: CONTROL; Other: ARA20; Other: ARA40; Other: TAG20; Other: TAG40 |
| Group W: EFABCD | Experimental | Participants will receive all six blind-coded samples, in the order E, F, A, B, C, D. There will be a minimum of 7 days washout between samples. Receives: Other: SUCROSE; Other: CONTROL; Other: ARA20; Other: ARA40; Other: TAG20; Other: TAG40 |
| Group X: DEFABC | Experimental | Participants will receive all six blind-coded samples, in the order D, E, F, A, B, C. There will be a minimum of 7 days washout between samples. Receives: Other: SUCROSE; Other: CONTROL; Other: ARA20; Other: ARA40; Other: TAG20; Other: TAG40 |
| Group Y: CDEFAB | Experimental | Participants will receive all six blind-coded samples, in the order C, D, E, F, A, B. There will be a minimum of 7 days washout between samples. Receives: Other: SUCROSE; Other: CONTROL; Other: ARA20; Other: ARA40; Other: TAG20; Other: TAG40 |
| Group Z: BCDEFA | Experimental | Participants will receive all six blind-coded samples, in the order B, C, D, E, F, A. There will be a minimum of 7 days washout between samples. Receives: Other: SUCROSE; Other: CONTROL; Other: ARA20; Other: ARA40; Other: TAG20; Other: TAG40 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Integrated area under the curve (iAUC) for plasma glucose.
Differences in the iAUC for plasma glucose after consuming each product.
Measured: 120 minutes
Secondary outcomes (7)
Peak plasma glucose
Differences in the peak value for plasma glucose after consuming each product.
Measured: 120 minutes
Integrated area under the curve (iAUC) for plasma insulin.
Differences in the iAUC for plasma insulin after consuming each product.
Measured: 120 minutes.
Peak plasma insulin
Differences in the peak value for plasma insulin after consuming each product.
Measured: 120 minutes.
Integrated area under the curve (iAUC) and peak value for plasma GLP-1.
Differences in the iAUC and peak value for plasma GLP-1 after consuming each product.
Measured: 120 minutes.
Integrated area under the curve (iAUC) and peak value for plasma GIP.
Differences in the iAUC and peak value for plasma GIP after consuming each product.
Measured: 120 minutes.
Food intake at ad libitum buffet meal
Total energy intake, macronutrient intake at ad libitum meal 120 minutes after product consumption.
Measured: 60 minutes
24 hour food intake
Total energy intake, macronutrient intake until midnight after product consumption.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2022
- Study startMay 2022 (estimated)
- Primary completionNov 2022 (estimated)
- Study completionNov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glycaemic Response in Healthy ParticipantsStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Collaborators
- Nottingham University Hospitals NHS Trust
- Responsible party
- Sponsor
- Investigators
- Preeti Jethwa, PhD, Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05353712
- Sponsor's protocol ID
- 22013
- Status last verified
- Apr 2022
- First submitted
- 25 Apr 2022
- Last updated
- 29 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Consuming Products Containing Rare Sugars Alongside Sucrose on Glycaemic Response in Healthy Adults
- ClinicalTrials.gov ID
- NCT05353712
- Acronym / sponsor ID
- 22013
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Collaborators
- Nottingham University Hospitals NHS Trust
- Study start
- May 2022 (estimated)
- Primary completion
- Nov 2022 (estimated)
- Study completion
- Nov 2022 (estimated)
- First posted
- 29 Apr 2022 (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.
Food manufacturers are being tasked to reduce the added sugar content of products. Rare, but natural sugars, may serve as useful sweeteners as they are low-calorie, safe, sweet and have a mild taste. Previous studies have shown that consuming rare sugars alongside other carbohydrates leads to a lower spike in blood glucose after eating. This means that products containing rare sugars may provide health benefits. However, most studies use rare sugars in a glucose drink, so the effect of consuming rare sugars in foods is not known.
The aim of this study is to find out whether consuming sweet crème products containing rare sugars reduces the blood glucose response compared to sucrose-only products. The effect of the rare sugar products on hunger and appetite will also be assessed.
Participants will attend the Clinical Research Facility on 6 occasions, after fasting for 10 hours. At each visit, they will consume a different sample of sweet crème. They will be asked to give blood samples before eating the sample, and at regular intervals for 2 hours afterwards. They will also complete questionnaires to assess their appetite using linear scales. Blood samples will be analysed in the laboratory to measure the level of glucose and insulin at each time point. The changes in blood glucose and insulin after consuming the different samples will be compared to find out if the samples containing rare sugars reduced the response.
Detailed description
Main Hypotheses:
This study is designed to test two main hypotheses:
- Sweet crème products containing the rare sugars arabinose or tagatose will cause a lower spike in blood glucose and insulin than sucrose-only products.
- Sweet crème products containing the rare sugars arabinose or tagatose will be no less satiating than sucrose-only products.
The null hypotheses are therefore:
- Levels of blood glucose and insulin are not significantly different after consuming sweet crème products containing rare sugars compared to sucrose-only products.
- Appetite and food intake are significantly higher after consuming sweet crème products containing rare sugars compared to sucrose-only products.
Study Overview:
This study will be a double-blind crossover trial, allowing each participant to act as their own control. Twenty participants will be recruited and fully informed about the study before giving informed consent. Eligible participants will attend the Clinical Research Facility on 6 separate mornings following an overnight fast. On each occasion participants will consume 40-50g of sweet crème served with commercially available sweet wafers. Sweet crème samples will contain vegetable fat and sucrose with or without the addition of D-tagatose or L-arabinose. Neither the participants or the researchers administering the tests will be aware of which sample is being consumed at each visit. Blood samples will be taken before consumption and at regular intervals for 120 minutes afterwards. Blood samples will be analysed to measure plasma glucose, insulin, and the appetite-regulating hormones GLP-1 and GIP. During each visit participants will also be asked to complete questionnaires assessing their hunger and desire to eat, and any gastrointestinal symptoms.
Samples:
Six different sweet crème samples will be included as listed below:
SUC- Full-sucrose sample (2.5:1 sucrose:vegetable fat)
CONTROL- Reduced-sucrose sample (1.5:1 sucrose:fat)
ARA20- Low-dose arabinose sample (1.5:1:0.5 sucrose:fat:arabinose)
ARA40- High-dose arabinose sample (1.5:1:1 sucrose:fat:arabinose)
TAG20- Low-dose tagatose sample (1.5:1:0.5 sucrose:fat:tagatose)
TAG40- High-dose tagatose sample (1.5:1:1 sucrose:fat:tagatose)
Using these samples, we will be able to investigate the effect of adding rare sugars to a constant sucrose/fat load (by comparing each experimental product with the control product), and also to investigate the effect of replacing sucrose with rare sugars (by comparing ARA40 and TAG40 products with the SUC product).
Study visits:
Each participant will visit on 6 occasions and consume one of the six samples on each visit in a randomised order.
Visits will be separated by at least one week, so each participant is expected to be involved in the study for 2-3 months from start to finish. A randomised crossover design has been selected so that each participant can act as their own control, which reduces the impact of variation in glycaemic response between individuals. The crossover design will therefore allow us to detect significant differences with a smaller number of participants.
At each clinic visit we will measure the glycaemic response (increase in blood glucose and insulin), using methods similar to the standard methodology for assessing glycaemic index. We will also evaluate the effect of the samples on hunger and desire to eat, and gastrointestinal symptoms, using adapted validated questionnaires.
The procedures for each clinic visit are summarised below:
- Pre-visit fast: Participants will fast for 10 hours before visit. All visits will be scheduled before 10am.
- Clinic visits: Participants will visit the clinic on 6 occasions, separated by at least one week. Each visit will last around 3 hours. Every effort will be made to ensure participants are comfortable during clinic visits. Participants will be seated comfortably throughout, and will be asked to remain seated as much as possible. They will be allowed to read or use laptops/phones, and toilet visits will be permitted.
- Health questionnaire: An initial health questionnaire will ask for details of BMI, smoking, alcohol consumption, habitual exercise and gastrointestinal symptoms. Questionnaires on subsequent visits will assess gastrointestinal symptoms only.
- Blood sampling: Research nurses at the CRF will insert cannula in a vein in the hand. Blood will be sampled at baseline and at 15, 30, 45, 60, 90 and 120 minutes after consumption of the sample.
- Consumption of product and sensory question: Researchers will ask participants to consume a sample consisting of 40-50g sweet crème served with commercially available wafers. They will be asked to rate their liking of the product on a 9-point hedonic scale. The quantity and composition of the samples has been carefully considered to ensure that they will cause a sufficient glycaemic response for us to be able to detect significant differences between samples. The composition is similar to typical sweet crème products (eg the centre of an Oreo biscuit), and it will be served with ice cream wafers to increase the palatability for participants. Participants will be asked to rate their liking of each sample immediately after consuming it using a hedonic scale. Neither the participant nor the researcher administering the clinic visit will be aware of which sample is being consumed at each visit.
- Appetite questionnaires: Researchers will administer paper-based questionnaires using visual analogue scores to ask participants how hungry/full they feel and their desire to eat certain foods. In order to capture changes in appetite over the clinic visit, participants will be asked to complete the same questionnaire at baseline and at 35, 65 and 125 minutes after consuming the product.
- Buffet meal: After the 120 minute blood sampling, cannulas will be removed and participants will be offered a buffet meal consisting of a range of sweet and savoury foods, served with water. Researchers will record the food intake of each participant.
- 24 hour food diary: Participants will be asked to record their food intake for the rest of the day (until midnight on the day of the study visit) on a paper-based food diary.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Group T: ABCDEF | Experimental | Other: SUCROSE, Other: CONTROL, Other: ARA20, Other: ARA40, Other: TAG20, Other: TAG40Participants will receive all six blind-coded samples, in the order A, B, C, D, E, F. There will be a minimum of 7 days washout between samples. |
| Group V: FABCDE | Experimental | Other: SUCROSE, Other: CONTROL, Other: ARA20, Other: ARA40, Other: TAG20, Other: TAG40Participants will receive all six blind-coded samples, in the order F, A, B, C, D, E. There will be a minimum of 7 days washout between samples. |
| Group W: EFABCD | Experimental | Other: SUCROSE, Other: CONTROL, Other: ARA20, Other: ARA40, Other: TAG20, Other: TAG40Participants will receive all six blind-coded samples, in the order E, F, A, B, C, D. There will be a minimum of 7 days washout between samples. |
| Group X: DEFABC | Experimental | Other: SUCROSE, Other: CONTROL, Other: ARA20, Other: ARA40, Other: TAG20, Other: TAG40Participants will receive all six blind-coded samples, in the order D, E, F, A, B, C. There will be a minimum of 7 days washout between samples. |
| Group Y: CDEFAB | Experimental | Other: SUCROSE, Other: CONTROL, Other: ARA20, Other: ARA40, Other: TAG20, Other: TAG40Participants will receive all six blind-coded samples, in the order C, D, E, F, A, B. There will be a minimum of 7 days washout between samples. |
| Group Z: BCDEFA | Experimental | Other: SUCROSE, Other: CONTROL, Other: ARA20, Other: ARA40, Other: TAG20, Other: TAG40Participants will receive all six blind-coded samples, in the order B, C, D, E, F, A. There will be a minimum of 7 days washout between samples. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy adults of any gender and any sociodemographic background, who are capable of giving informed consent.
- Aged 18 years or over (no upper age limit).
- Able to understand spoken and written English well enough to understand the consent forms and information sheets, and to give responses to questionnaires.
Key exclusion criteria (3 listed)
- Diagnosed hyperglycaemia, insulin resistance, diabetes or high blood pressure.
- Allergy, intolerance, sensitivity or dietary restriction that would prevent the consumption of the sweet crème samples.
- Anxiety/phobias that would prevent the sampling of venous blood.
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 |
|---|---|---|
| SUCROSE50g sweet creme composed of 14.3g vegetable fat and 35.7g sucrose. | Other | Group T: ABCDEF, Group V: FABCDE, Group W: EFABCD, Group X: DEFABC, Group Y: CDEFAB, Group Z: BCDEFA |
| CONTROL35.7g sweet creme composed of 14.3g vegetable fat and 21.4g sucrose. | Other | Group T: ABCDEF, Group V: FABCDE, Group W: EFABCD, Group X: DEFABC, Group Y: CDEFAB, Group Z: BCDEFA |
| ARA2042.9g sweet creme composed of 14.3g vegetable fat, 21.4g sucrose and 7.1g L-arabinose | Other | Group T: ABCDEF, Group V: FABCDE, Group W: EFABCD, Group X: DEFABC, Group Y: CDEFAB, Group Z: BCDEFA |
| ARA4050g sweet creme composed of 14.3g vegetable fat, 21.4g sucrose and 14.3g L-arabinose | Other | Group T: ABCDEF, Group V: FABCDE, Group W: EFABCD, Group X: DEFABC, Group Y: CDEFAB, Group Z: BCDEFA |
| TAG2042.9g sweet creme composed of 14.3g vegetable fat, 21.4g sucrose and 7.1g D-tagatose | Other | Group T: ABCDEF, Group V: FABCDE, Group W: EFABCD, Group X: DEFABC, Group Y: CDEFAB, Group Z: BCDEFA |
| TAG4050g sweet creme composed of 14.3g vegetable fat, 21.4g sucrose and 14.3g L-arabinose | Other | Group T: ABCDEF, Group V: FABCDE, Group W: EFABCD, Group X: DEFABC, Group Y: CDEFAB, Group Z: BCDEFA |
Primary outcome
Integrated area under the curve (iAUC) for plasma glucose.
Time frame: 120 minutes
Differences in the iAUC for plasma glucose after consuming each product.
7 secondary outcomes
Peak plasma glucose
Time frame: 120 minutes
Integrated area under the curve (iAUC) for plasma insulin.
Time frame: 120 minutes.
Peak plasma insulin
Time frame: 120 minutes.
Integrated area under the curve (iAUC) and peak value for plasma GLP-1.
Time frame: 120 minutes.
Integrated area under the curve (iAUC) and peak value for plasma GIP.
Time frame: 120 minutes.
Food intake at ad libitum buffet meal
Time frame: 60 minutes
24 hour food intake
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2022.
- Individual participant dataSharing planned: No
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.
Alison Smith, MSc contact
Preeti Jethwa, PhD principal investigator
University of Nottingham
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SUCROSE, ARA20 and ARA40 in people with Glycaemic Response in Healthy Participants, run by University of Nottingham at 2 sites in United Kingdom.
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 3 inclusion and 3 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 29 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Preeti Jethwa, PhD (01159516129, Preeti.Jethwa@nottingham.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Integrated area under the curve (iAUC) for plasma glucose. (time frame: 120 minutes). 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 29 Apr 2022.