HealthyNCT06063096
Gastrointestinal Tolerance of D-allulose in Children
A study testing D-allulose in people with Healthy, run by Tate & Lyle.
Trial summary
D-allulose, a low-calorie sugar, provides an attractive alternative to sucrose and added sugars in products. This study aimed to verify the tolerance of d-allulose in children, in doses that are Generally Recognised As Safe (GRAS) and below maximum tolerable levels on g/kg basis. Read more about this study
- Who is it for?
- Ages 6 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- D-allulose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 15 Dec 2015to 3 Mar 2016
- 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 6 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy children of 6 to 8 years of age
- Weight-for-age between the 5th and the 90th percentile as per the Centre for Disease Control and Prevention Growth Charts
- Accustomed to having lunch between 12.00 pm and 2.30 pm
- Routinely had up to 3 bowel movements per day or as few as 3 bowel movements per week
- Were able to drink 120 ml within 30 minutes
- With parents willing to continue their child's normal food and beverage intake and physical activity throughout the duration of the study
- With parents willing and able to attend for all 7 visits
Who cannot join
- Any major trauma or surgical event within the 3 months prior to screening
- History or presence of clinically significant endocrine or GI disorder
- Functional GI Disorders in accordance with Rome III Diagnostic Questionnaire for Paediatric Functional GI Disorders
- More than 1 loose stool in the 48 hours preceding dosing, that met a Type 6 or Type 7 description on the Bristol Stool Chart
- Use of any prescription medication, including antibiotics, laxatives and steroids
- Regular GI complaints, such as stomach upsets, diarrhoea, constipation, flatulence, abdominal colic
Show all 11Show fewer
- Known intolerance or sensitivity to any of the study products, abdominal or anorectal surgery
- Psychiatric disorders, anxiety, and depression
- Lactose intolerance
- Use of supplements that may have affected GI system including laxatives, fibre, and iron supplements
- Exposure to any non-registered drug product within 30 days prior to screening visit.
About this study
Official title: Gastrointestinal Tolerance of D-allulose in Children: an Acute, Randomised, Double-blind, Placebo-controlled, Cross-over Study
D-allulose, a low-calorie sugar, provides an attractive alternative to sucrose and added sugars in products. This study aimed to verify the tolerance of d-allulose in children, in doses that are Generally Recognised As Safe (GRAS) and below maximum tolerable levels on g/kg basis.
- Conditions
- Healthy
- Being tested
- D-allulose, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D-alluloseDietary supplement
Fruit-flavoured drink with d-allulose at 2 dosages
PlaceboDietary supplement
Fruit-flavoured drink with high fructose corn syrup
| Study group | Role | What they receive |
|---|---|---|
| Allulose Dose 1 | Active comparator | Fruit-flavoured drink with allulose at Dose 1 (2.5 g per 120 ml) Receives: Dietary Supplement: D-allulose |
| Allulose Dose 2 | Active comparator | Fruit-flavoured drink with allulose at Dose 2 (4.3 g per 120 ml) Receives: Dietary Supplement: D-allulose |
| Placebo Comparator: Control (CON) | Placebo comparator | Control drink containing high fructose corn syrup. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in the number of participants experiencing at least one stool that met a Type 6 or Type 7 description on the Bristol Stool Chart, within 24 hours after study product intake
Difference in the number of subjects experiencing at least one stool that met a Type 6 or Type 7 description on the Bristol Stool Chart
Measured: within 24 hours after study product intake
Secondary outcomes (2)
Number of subjects who experienced at least one loose or watery stool that met a Type 6 or Type 7 description on the Bristol Stool Chart
Stool frequency, measured as the number of subjects who experienced at least one loose or watery stool that met a Type 6 or Type 7 description on the Bristol Stool Chart
Measured: in a 24-hour period post-consumption of intervention
Frequency of the GI symptom event and frequency of participants reporting GI symptoms events by the severity and causality (i.e., related, not related) for each treatment group recorded at Visits 3, 5 and 7, for pre- and post-dose administration
Report common gastrointestinal symptoms including abdominal pain, bloating, cramping, abdominal rumbling, excess flatus, and and nausea associated with d-allulose consumption. These were reported as the frequency of the event and frequency of participants reporting events by the severity and causality (i.e., related, not related) for each treatment group recorded at Visits 3, 5 and 7, for pre- and post-dose administration. The severity of the event was categorized in three levels (mild, moderate, severe).
Measured: in the 24-hour period post-consumption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2023
- Study start15 Dec 2015
- Primary completion3 Mar 2016
- Study completion3 Mar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Acute, randomised, double-blind, placebo-controlled, cross-over
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tate & Lyle
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06063096
- Sponsor's protocol ID
- TateLyle
- Status last verified
- Sep 2023
- First submitted
- 2 Aug 2023
- Last updated
- 2 Oct 2023
- 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 2 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gastrointestinal Tolerance of D-allulose in Children: an Acute, Randomised, Double-blind, Placebo-controlled, Cross-over Study
- ClinicalTrials.gov ID
- NCT06063096
- Acronym / sponsor ID
- TateLyle
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Tate & LyleIndustry (pharma, biotech, devices)
- Study start
- 15 Dec 2015 (actual)
- Primary completion
- 3 Mar 2016 (actual)
- Study completion
- 3 Mar 2016 (actual)
- First posted
- 2 Oct 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.
D-allulose, a low-calorie sugar, provides an attractive alternative to sucrose and added sugars in products. This study aimed to verify the tolerance of d-allulose in children, in doses that are Generally Recognised As Safe (GRAS) and below maximum tolerable levels on g/kg basis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Acute, randomised, double-blind, placebo-controlled, cross-over
| Arm | Type | Receives |
|---|---|---|
| Allulose Dose 1 | Active comparator | Dietary Supplement: D-alluloseFruit-flavoured drink with allulose at Dose 1 (2.5 g per 120 ml) |
| Allulose Dose 2 | Active comparator | Dietary Supplement: D-alluloseFruit-flavoured drink with allulose at Dose 2 (4.3 g per 120 ml) |
| Placebo Comparator: Control (CON) | Placebo comparator | Dietary Supplement: PlaceboControl drink containing high fructose corn syrup. |
Who may qualify
- Ages
- 6 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Healthy children of 6 to 8 years of age
- Weight-for-age between the 5th and the 90th percentile as per the Centre for Disease Control and Prevention Growth Charts
- Accustomed to having lunch between 12.00 pm and 2.30 pm
- Routinely had up to 3 bowel movements per day or as few as 3 bowel movements per week
- Were able to drink 120 ml within 30 minutes
Key exclusion criteria (11 listed)
- Any major trauma or surgical event within the 3 months prior to screening
- History or presence of clinically significant endocrine or GI disorder
- Functional GI Disorders in accordance with Rome III Diagnostic Questionnaire for Paediatric Functional GI Disorders
- More than 1 loose stool in the 48 hours preceding dosing, that met a Type 6 or Type 7 description on the Bristol Stool Chart
- Use of any prescription medication, including antibiotics, laxatives and steroids
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-alluloseFruit-flavoured drink with d-allulose at 2 dosages | Dietary supplement | Allulose Dose 1, Allulose Dose 2 |
| PlaceboFruit-flavoured drink with high fructose corn syrup | Dietary supplement | Placebo Comparator: Control (CON) |
Primary outcome
Difference in the number of participants experiencing at least one stool that met a Type 6 or Type 7 description on the Bristol Stool Chart, within 24 hours after study product intake
Time frame: within 24 hours after study product intake
Difference in the number of subjects experiencing at least one stool that met a Type 6 or Type 7 description on the Bristol Stool Chart
2 secondary outcomes
Number of subjects who experienced at least one loose or watery stool that met a Type 6 or Type 7 description on the Bristol Stool Chart
Time frame: in a 24-hour period post-consumption of intervention
Frequency of the GI symptom event and frequency of participants reporting GI symptoms events by the severity and causality (i.e., related, not related) for each treatment group recorded at Visits 3, 5 and 7, for pre- and post-dose administration
Time frame: in the 24-hour period post-consumption
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 2 Oct 2023.
- Individual participant dataSharing planned: No
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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 D-allulose in people with Healthy, run by Tate & Lyle.
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 7 inclusion and 11 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 2 Oct 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. 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?
Difference in the number of participants experiencing at least one stool that met a Type 6 or Type 7 description on the Bristol Stool Chart, within 24 hours after study product intake (time frame: within 24 hours after study product intake). 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 2 Oct 2023.