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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in United Kingdom

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.

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 groups in NCT06330636
Study groupRoleWhat they receive
D-AlluloseExperimental15g D-Allulose added to a high glycaemic index oat porridge
Receives: Other: D-Allulose
SaccharinPlacebo comparatorSodium 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.

  1. 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

  2. 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)
  1. Glycaemia Test

    Postprandial glycaemic response to test breakfast

    Measured: 180 minutes after breakfast ingestion

  2. Glycaemia Placebo

    Postprandial glycaemic response to placebo breakfast

    Measured: 180 minutes after breakfast ingestion

  3. Insulinemia Test

    Postprandial circulating insulin response to test breakfast

    Measured: 180 minutes after breakfast ingestion

  4. Insulinemia Placebo

    Postprandial circulating insulin response to placebo breakfast

    Measured: 180 minutes after breakfast ingestion

  5. iAUC 180 Insulin Test

    Incremental area under the curve (180min) for circulating insulin on test day

    Measured: 180 minutes after breakfast ingestion

  6. iAUC 180 Insulin Placebo

    Incremental area under the curve (180min) for circulating insulin on placebo day

    Measured: 180 minutes after breakfast ingestion

  7. 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

  8. 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

  9. 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

  10. 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

  11. Dietary Fibre

    Dietary fibre intake calculated from 4-day dietary records using nutritional database

    Measured: 4 days

  12. Carbohydrate %

    Dietary carbohydrate intake expressed as a percentage of total energy intake.

    Measured: 4 days

  13. Fat %

    Dietary fat intake expressed as a percentage of total energy intake.

    Measured: 4 days

  14. Protein %

    Dietary protein intake expressed as a percentage of total energy intake.

    Measured: 4 days

  15. 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.

  1. First posted26 Mar 2024
  2. Study start11 Sep 2023
  3. Primary completion28 Mar 2024
  4. Study completion24 Jun 2024

Resources

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)
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

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.

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