Sugar; Blood, HighNCT06330636
The Acute Effect of D-allulose Consumption on Postprandial Glycaemia
A study testing D-Allulose and Sodium Saccharin in people with Sugar; Blood, High, run by University of Nottingham at 1 site in United Kingdom.
Trial summary
The rare sugar D-Allulose, when consumed in a drink before eating has been shown to reduce the blood glucose response to high carbohydrate drinks or meals in people who are healthy, or have elevated fasting blood glucose concentration. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Sugar; Blood, High
- What is being tested?
- D-Allulose and Sodium Saccharin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 11 Sep 2023to 24 Jun 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participant is willing and able to give informed consent for participation in the study
- Not currently taking any medications (using contraceptive medication is acceptable)
- Aged between 18 and 40 years
- Healthy weight or overweight (Body Mass Index 19-30 kg/m2)
Who cannot join
- Reporting functional gastrointestinal problems, such as irritable bowel syndrome, gastroparesis or reflux
- History of inflammatory bowel diseases such as Crohn's disease or Ulcerative colitis
- Diabetes mellitus
- Surgical resection of gastrointestinal tract.
- Food allergies, intolerances or acceptability issues related to the standard meal, including veganism, lactose intolerance and coeliac disease.
- Following a restricted habitual diet e.g. low carbohydrate, high protein or meal replacement diet
Show all 13Show fewer
- Following a restrictive dietary pattern e.g. intermittent fasting
- Currently following a reduced-energy diet to control body weight
- Pregnant or breast feeding
- History or current psychiatric illness
- History or current neurological condition (e.g. epilepsy)
- Taking regular medication, including over the counter and prescription drugs; Oral contraception medication and intermittent use of over the counter pain relief is acceptable.
- Having taken part in a research study in the last 3 months involving invasive procedures or an inconvenience allowance
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
David Greenfield Human Physiology Laboratories
Nottingham, Notts, NG72UH
About this study
Official title: The Acute Effect of D-allulose Consumption on Postprandial Glycaemia in Healthy Individuals
The rare sugar D-Allulose, when consumed in a drink before eating has been shown to reduce the blood glucose response to high carbohydrate drinks or meals in people who are healthy, or have elevated fasting blood glucose concentration. However, the effectiveness of D-allulose to suppress blood glucose concentration when added into carbohydrate containing food products has not been previously reported and as the potential use of allulose is as a sucrose replacer in foods, rather than drinks, it is important that effects and efficacy are tested in this format. The study aimed to extend understanding of the acute effects of D-allulose consumption in humans by testing whether post-eating blood glucose concentration can be modified by the presence of D-allulose in a high carbohydrate breakfast and collecting data on any adverse gastrointestinal effects of consuming D-allulose.
Read the detailed description
Twelve healthy individuals (age 18-40y, BMI 19-30 kg/m2) will be recruited following a health screening. An equal number of males and females will be sought to improve generalisability of data, but the study will not powered to explore sex differences in response. After a successful screening and recruitment, participants will be asked to record everything that they eat and drink in a dietary record for 4 days (3 week and 1 weekend day). This will be analysed using dietary analysis software (Nutritics, Eire) for energy, macronutrient and fibre intake to characterise the participants' habitual diets.
At 2 subsequent laboratory visits, volunteers will be asked to refrain from drinking alcohol and doing strenuous exercise on the day before. They will arrive at the laboratory by 9am after an overnight fast and a retrograde cannula will be inserted into a superficial dorsal hand vein after prior intradermal infiltration with ~0.01ml 1% lidocaine. The cannulated hand will be placed into a hot air hand warmer for the duration of the study to allow sampling of arterialised venous blood for assessment of blood glucose and insulin concentration. A 1ml fasting blood sample will be taken and participants will be asked to complete a short questionnaire containing 6 visual analogue scales. Four of these will assess subjective appetite (How full do you feel? How much food do you think that you could eat? How hungry do you feel? How strong is your desire to eat?) with 2 addressing possible gastrointestinal symptoms (How much abdominal pain are you currently feeling? How much intestinal gurgling are you experiencing?). Participants will be asked to evaluate how strong their feelings are by placing a vertical mark along a 100mm horizontal line; 0 representing not experiencing the criterion at that time, and 100 indicating experiencing the greatest degree of that feeling that they could imagine. The combined appetite score (CAS) will be calculated according to standard methods and expressed as incremental change from the score reported at the end of the meal (iCAS).
Once baseline measures have been made, participants will be given a porridge breakfast (50g Ready Brek™, 15g skimmed milk powder, 10g glucose, 200ml hot water) to which has been added 15g of D-allulose or 1 saccharin tablets (Sweetex™). Fifteen grams of D-allulose and 1 Sweetex™ will be approximately equivalent to the sweetness provided by 10g (2 tsp) of sucrose (table sugar). The base porridge will provide 1.1MJ (265 kcal), 47g carbohydrate (29.1g starch, 17.8g sugars), 10.9g protein and 3.7g fat. The saccharin tablets will add no further energy to the breakfast, but the D-allulose will add a further 25kJ (6 kcal) to the porridge. Both porridge meals have the same volume, taste and consistency. Further 1ml blood samples will be taken at 5, 10, 15, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150 and 180 minutes after finishing eating breakfast, with the questionnaire completed immediately after eating and at the 20, 40, 60, 90, 120, 150 and 180 minute time points. At 180 minutes, the cannula will be removed, and participants will be offered refreshments before leaving the laboratory. Therefore, the time in the laboratory on each study visit will be ~4 hours and the amount of blood collected will be <20ml.
The second study visit will be scheduled for at least a week after visit 1, and in the time between visits participants will resume their usual diet and lifestyle. At the second visit, the protocol described above will be repeated, but participants will receive the breakfast that they did not receive at visit 1 i.e. if they received the porridge with D-allulose at visit 1, then they will receive the porridge with saccharin at visit 2 and vice versa.
The order in which the breakfasts are given will be randomly allocated according to a predetermined randomisation plan. The randomisation sequence will be generated for males and females separately to ensure a balanced allocation within sex. Individuals will be randomised at the first laboratory visit, with their randomisation number allocated sequentially. Any participants who withdraw from the study will be replaced if time allows.
- Conditions
- Sugar; Blood, High
- Being tested
- D-Allulose, Sodium Saccharin
- Keywords
- glycaemia response, D-allulose, dietary carbohydrates
- Medical subject headings
- Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D-AlluloseOther
Also called Test Day
Test breakfast
Sodium SaccharinOther
Also called Control Day
placebo breakfast
| Study group | Role | What they receive |
|---|---|---|
| D-Allulose | Experimental | 15g D-Allulose added to a high glycaemic index oat porridge Receives: Other: D-Allulose |
| Saccharin | Placebo comparator | Sodium saccharin (1x 'Sweetex' tablet) added to a high glycaemic index oat porridge Receives: Other: Sodium Saccharin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incremental area under the curve (iAUC) 180 Glucose Test
Incremental area under the curve (180min) for blood glucose on test day
Measured: 180 minutes after breakfast ingestion
iAUC 180 Glucose Placebo
Incremental area under the curve (180min) for blood glucose on placebo day
Measured: 180 minutes after breakfast ingestion
Secondary outcomes (15)
Glycaemia Test
Postprandial glycaemic response to test breakfast
Measured: 180 minutes after breakfast ingestion
Glycaemia Placebo
Postprandial glycaemic response to placebo breakfast
Measured: 180 minutes after breakfast ingestion
Insulinemia Test
Postprandial circulating insulin response to test breakfast
Measured: 180 minutes after breakfast ingestion
Insulinemia Placebo
Postprandial circulating insulin response to placebo breakfast
Measured: 180 minutes after breakfast ingestion
iAUC 180 Insulin Test
Incremental area under the curve (180min) for circulating insulin on test day
Measured: 180 minutes after breakfast ingestion
iAUC 180 Insulin Placebo
Incremental area under the curve (180min) for circulating insulin on placebo day
Measured: 180 minutes after breakfast ingestion
iCAS Test
incremental 'combined appetite score' response following test breakfast (min 0 - max 100) with a higher number indicating greater appetite
Measured: 180 minutes after breakfast ingestion
iCAS Placebo
incremental 'combined appetite score' response following placebo breakfast (min 0 - max 100) with a higher number indicating greater appetite
Measured: 180 minutes after breakfast ingestion
abdominal discomfort test
abdominal discomfort visual analogue score (min 0- max 100 scale) after test breakfast. Greater score indicates greater discomfort
Measured: 180 minutes after breakfast ingestion
abdominal discomfort placebo
abdominal discomfort visual analogue score (min 0- max 100 scale) after placebo breakfast. Greater score indicates greater discomfort
Measured: 180 minutes after breakfast ingestion
Dietary Fibre
Dietary fibre intake calculated from 4-day dietary records using nutritional database
Measured: 4 days
Carbohydrate %
Dietary carbohydrate intake expressed as a percentage of total energy intake.
Measured: 4 days
Fat %
Dietary fat intake expressed as a percentage of total energy intake.
Measured: 4 days
Protein %
Dietary protein intake expressed as a percentage of total energy intake.
Measured: 4 days
Sugars %
Dietary sugars intake expressed as a percentage of total energy intake.
Measured: 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2024
- Study start11 Sep 2023
- Primary completion28 Mar 2024
- Study completion24 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sugar; Blood, HighStudies 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
- Model description
- Randomised, placebo controlled cross over design
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elizabeth Simpson, University of Nottingham
- Investigators
- Liz Simpson, PhD, Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06330636
- Sponsor's protocol ID
- 336-0723
- Status last verified
- Jun 2024
- First submitted
- 11 Mar 2024
- Last updated
- 25 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymised research data will be made available on request to the study PI
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Acute Effect of D-allulose Consumption on Postprandial Glycaemia in Healthy Individuals
- ClinicalTrials.gov ID
- NCT06330636
- Acronym / sponsor ID
- 336-0723
- Conditions
- Sugar; Blood, High
- Keywords
- glycaemia response, D-allulose, dietary carbohydrates
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Study start
- 11 Sep 2023 (actual)
- Primary completion
- 28 Mar 2024 (actual)
- Study completion
- 24 Jun 2024 (actual)
- First posted
- 26 Mar 2024 (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.
The rare sugar D-Allulose, when consumed in a drink before eating has been shown to reduce the blood glucose response to high carbohydrate drinks or meals in people who are healthy, or have elevated fasting blood glucose concentration. However, the effectiveness of D-allulose to suppress blood glucose concentration when added into carbohydrate containing food products has not been previously reported and as the potential use of allulose is as a sucrose replacer in foods, rather than drinks, it is important that effects and efficacy are tested in this format. The study aimed to extend understanding of the acute effects of D-allulose consumption in humans by testing whether post-eating blood glucose concentration can be modified by the presence of D-allulose in a high carbohydrate breakfast and collecting data on any adverse gastrointestinal effects of consuming D-allulose.
Detailed description
Twelve healthy individuals (age 18-40y, BMI 19-30 kg/m2) will be recruited following a health screening. An equal number of males and females will be sought to improve generalisability of data, but the study will not powered to explore sex differences in response. After a successful screening and recruitment, participants will be asked to record everything that they eat and drink in a dietary record for 4 days (3 week and 1 weekend day). This will be analysed using dietary analysis software (Nutritics, Eire) for energy, macronutrient and fibre intake to characterise the participants' habitual diets.
At 2 subsequent laboratory visits, volunteers will be asked to refrain from drinking alcohol and doing strenuous exercise on the day before. They will arrive at the laboratory by 9am after an overnight fast and a retrograde cannula will be inserted into a superficial dorsal hand vein after prior intradermal infiltration with ~0.01ml 1% lidocaine. The cannulated hand will be placed into a hot air hand warmer for the duration of the study to allow sampling of arterialised venous blood for assessment of blood glucose and insulin concentration. A 1ml fasting blood sample will be taken and participants will be asked to complete a short questionnaire containing 6 visual analogue scales. Four of these will assess subjective appetite (How full do you feel? How much food do you think that you could eat? How hungry do you feel? How strong is your desire to eat?) with 2 addressing possible gastrointestinal symptoms (How much abdominal pain are you currently feeling? How much intestinal gurgling are you experiencing?). Participants will be asked to evaluate how strong their feelings are by placing a vertical mark along a 100mm horizontal line; 0 representing not experiencing the criterion at that time, and 100 indicating experiencing the greatest degree of that feeling that they could imagine. The combined appetite score (CAS) will be calculated according to standard methods and expressed as incremental change from the score reported at the end of the meal (iCAS).
Once baseline measures have been made, participants will be given a porridge breakfast (50g Ready Brek™, 15g skimmed milk powder, 10g glucose, 200ml hot water) to which has been added 15g of D-allulose or 1 saccharin tablets (Sweetex™). Fifteen grams of D-allulose and 1 Sweetex™ will be approximately equivalent to the sweetness provided by 10g (2 tsp) of sucrose (table sugar). The base porridge will provide 1.1MJ (265 kcal), 47g carbohydrate (29.1g starch, 17.8g sugars), 10.9g protein and 3.7g fat. The saccharin tablets will add no further energy to the breakfast, but the D-allulose will add a further 25kJ (6 kcal) to the porridge. Both porridge meals have the same volume, taste and consistency. Further 1ml blood samples will be taken at 5, 10, 15, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150 and 180 minutes after finishing eating breakfast, with the questionnaire completed immediately after eating and at the 20, 40, 60, 90, 120, 150 and 180 minute time points. At 180 minutes, the cannula will be removed, and participants will be offered refreshments before leaving the laboratory. Therefore, the time in the laboratory on each study visit will be ~4 hours and the amount of blood collected will be <20ml.
The second study visit will be scheduled for at least a week after visit 1, and in the time between visits participants will resume their usual diet and lifestyle. At the second visit, the protocol described above will be repeated, but participants will receive the breakfast that they did not receive at visit 1 i.e. if they received the porridge with D-allulose at visit 1, then they will receive the porridge with saccharin at visit 2 and vice versa.
The order in which the breakfasts are given will be randomly allocated according to a predetermined randomisation plan. The randomisation sequence will be generated for males and females separately to ensure a balanced allocation within sex. Individuals will be randomised at the first laboratory visit, with their randomisation number allocated sequentially. Any participants who withdraw from the study will be replaced if time allows.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomised, placebo controlled cross over design
| Arm | Type | Receives |
|---|---|---|
| D-Allulose | Experimental | Other: D-Allulose15g D-Allulose added to a high glycaemic index oat porridge |
| Saccharin | Placebo comparator | Other: Sodium SaccharinSodium saccharin (1x 'Sweetex' tablet) added to a high glycaemic index oat porridge |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Participant is willing and able to give informed consent for participation in the study
- Not currently taking any medications (using contraceptive medication is acceptable)
- Aged between 18 and 40 years
- Healthy weight or overweight (Body Mass Index 19-30 kg/m2)
Key exclusion criteria (13 listed)
- Reporting functional gastrointestinal problems, such as irritable bowel syndrome, gastroparesis or reflux
- History of inflammatory bowel diseases such as Crohn's disease or Ulcerative colitis
- Diabetes mellitus
- Surgical resection of gastrointestinal tract.
- Food allergies, intolerances or acceptability issues related to the standard meal, including veganism, lactose intolerance and coeliac disease.
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 |
|---|---|---|
| D-AlluloseAlso: Test DayTest breakfast | Other | D-Allulose |
| Sodium SaccharinAlso: Control Dayplacebo breakfast | Other | Saccharin |
Primary outcome
Incremental area under the curve (iAUC) 180 Glucose Test
Time frame: 180 minutes after breakfast ingestion
Incremental area under the curve (180min) for blood glucose on test day
iAUC 180 Glucose Placebo
Time frame: 180 minutes after breakfast ingestion
Incremental area under the curve (180min) for blood glucose on placebo day
15 secondary outcomes
Glycaemia Test
Time frame: 180 minutes after breakfast ingestion
Glycaemia Placebo
Time frame: 180 minutes after breakfast ingestion
Insulinemia Test
Time frame: 180 minutes after breakfast ingestion
Insulinemia Placebo
Time frame: 180 minutes after breakfast ingestion
iAUC 180 Insulin Test
Time frame: 180 minutes after breakfast ingestion
iAUC 180 Insulin Placebo
Time frame: 180 minutes after breakfast ingestion
iCAS Test
Time frame: 180 minutes after breakfast ingestion
iCAS Placebo
Time frame: 180 minutes after breakfast ingestion
abdominal discomfort test
Time frame: 180 minutes after breakfast ingestion
abdominal discomfort placebo
Time frame: 180 minutes after breakfast ingestion
Dietary Fibre
Time frame: 4 days
Carbohydrate %
Time frame: 4 days
Fat %
Time frame: 4 days
Protein %
Time frame: 4 days
Sugars %
Time frame: 4 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2024.
- Individual participant dataSharing planned: Yes. Anonymised research data will be made available on request to the study PI
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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.
Liz Simpson, PhD principal investigator
University of Nottingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing D-Allulose and Sodium Saccharin in people with Sugar; Blood, High, run by University of Nottingham at 1 site 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 4 inclusion and 13 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: finished, as of the sponsor's last update on 25 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incremental area under the curve (iAUC) 180 Glucose Test (time frame: 180 minutes after breakfast ingestion). The study lists 2 primary outcomes in all. 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 25 Jun 2024.