Blood SugarNCT05185960
Comparison of the Postprandial Glycemic and Insulinemic Response of ALLSWEET When Taken Alone or When Added to Sucrose
A study testing ALLSWEET®, ALLSWEET® and sucrose and Sucrose in people with Blood Sugar, run by Anderson Advanced Ingredients at 1 site in Canada.
Trial summary
This study will explore the postprandial glycemic response of ALLSWEET®, a non-GMO certified allulose, when consumed alone or with sucrose, compared to the consuming sucrose alone. On 3 separate days, subjects will consume in random order ALLSWEET® alone, ALLSWEET® added to sucrose, or sucrose alone. Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Sugar
- What is being tested?
- ALLSWEET®, ALLSWEET® and sucrose and Sucrose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteCanada
- Study dates
- 15 Sep 2021to 28 Oct 2021
- 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 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Individuals, 20-70 years of age, inclusive.
- Body mass index (BMI) between 18 and 33 kg/m², inclusive, at screening.
- Willing to maintain habitual diet, physical activity pattern, and body weight throughout the trial.
- Willing to maintain current dietary supplement and non exclusionary medication use throughout the trial.
- Willing to avoid the consumption of alcohol, unusual food intake, unusual physical activity and consumption of any flatulence promoting foods 24h prior to each study visit. Failure to follow will result in rescheduled visit.
- Understanding the study procedures and willing to provide informed consent to participate in the study and authorization to release relevant protected. health information to the study investigator.
Who cannot join
- Failure to meet any one of the inclusion criteria.
- Known history of gastrointestinal disease (e.g., diverticulitis, Crohns disease, coeliac disease etc.), bariatric surgery, AIDS, hepatitis, a history or presence of clinically important endocrine (including Type 1 or Type 2 diabetes mellitus), cardiovascular (including, but not limited to, atherosclerotic disease, history of myocardial infarction, peripheral arterial disease, stroke), pulmonary, or biliary diseases, or any condition which might, in the opinion of the medical director either: 1) make participation dangerous to the subject or to others, or 2) affect the results.
- Use of medications known to influence carbohydrate metabolism, gastrointestinal function or appetite, including, but not limited to adrenergic blockers, diuretics, thiazolidinediones, metformin and systemic corticosteroids within 4 weeks of the screening visit, or any medication which might, in the opinion of the medical director either: 1) make participation dangerous to the subject or to others, or 2) affect the results.
- Major trauma or surgical event within 3 months of screening.
- Unwillingness or inability to comply with the experimental procedures and to follow INQUIS health and safety policies.
- Known intolerance, sensitivity or allergy to test foods.
Show all 11Show fewer
- Extreme dietary habits, as judged by the Investigator (i.e. Atkins diet, very high protein diets, etc.).
- History of cancer in the prior two years, except for non-melanoma skin cancer.
- Exposure to any non-registered drug product within 30 d prior to screening.
- Self reported pregnancy or breastfeeding.
- Any history of an eating disorder (e.g., anorexia nervosa, bulimia nervosa, binge eating) diagnosed by a health professional.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Postprandial Glycemic and Insulinemic Response of ALLSWEET When Taken Alone or When Added to Sucrose: A Randomized, Double Blind, Controlled Clinical Trial in Healthy Individuals
This study will explore the postprandial glycemic response of ALLSWEET®, a non-GMO certified allulose, when consumed alone or with sucrose, compared to the consuming sucrose alone. On 3 separate days, subjects will consume in random order ALLSWEET® alone, ALLSWEET® added to sucrose, or sucrose alone. Blood samples for glucose and insulin analysis with be taken for 2 hours following consumption of the beverages.
Read the detailed description
Each subject will receive 3 test meals in a double blinded, randomized, crossover fashion.
- Test arm 1: 30g sucrose
- Test arm 2: 30g sucrose + 15g of ALLSWEET®
- Test arm 3: 15g ALLSWEET® All sweeteners will be mixed with 250ml of water.
Eligible subjects will be studied on 3 separate days over a period of 4 weeks or less, with at least 1 day in between test days. A fasting fingerprick blood sample will be collected for glucose and insulin analysis after which the test meal will be administered. Additional fingerprick blood samples will be drawn over the next 2 hours (15', 30', 45', 60', 90' and 120' after the first sip of the test drink).
Power calculation: A sample size of 15 subjects, is sufficient to detect a 25% difference in incremental area under the curve between meals with 80% statistical power.
Statistical Analysis: Incremental area under the curve values, blood glucose and insulin concentrations and increments at each time will be subjected to repeated-measures analysis of variance. After demonstration of significant heterogeneity, the significance of the differences between individual means will be assessed using Tukey's test to adjust for multiple comparisons, with the criterion for significance being two-tailed p<0.05. Means which differ by more than the least significant difference differ significantly.
- Conditions
- Blood Sugar
- Being tested
- ALLSWEET®, ALLSWEET® and sucrose, Sucrose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALLSWEET®Other
ALLSWEET®, is a non-GMO certified allulose developed by the study sponsor. It will be diluted in water.
ALLSWEET® and sucroseOther
ALLSWEET®, is a non-GMO certified allulose developed by the study sponsor. It will be added to sucrose (table sugar) and diluted in water.
SucroseOther
Table sugar. It will be consumed by diluting it in water.
| Study group | Role | What they receive |
|---|---|---|
| ALLSWEET® | Experimental | ALLSWEET® will be mixed with 250ml of water and an additional 125ml of water. Fingerprick blood samples will be taken for 2 hours following consumption of beverage in order to assess the glycemic response. Receives: Other: ALLSWEET® |
| ALLSWEET® consumed with sucrose | Experimental | ALLSWEET® and sucrose will be mixed with 250ml of water and an additional 125ml of water. Fingerprick blood samples will be taken for 2 hours following consumption of beverage in order to assess the glycemic response. Receives: Other: ALLSWEET® and sucrose |
| Sucrose | Active comparator | Sucrose will be mixed with 250ml of water and an additional 125ml of water. Fingerprick blood samples will be taken for 2 hours following consumption of beverage in order to assess the glycemic response. Receives: Other: Sucrose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postprandial glycemic response
Compare the postprandial glucose incremental area under the curve response of ALLSWEET® with sucrose when taken alone or when added to sucrose.
Measured: Acute response over 2 hours
Secondary outcomes (2)
Postprandial glycemic response
Compare the postprandial glucose levels at each time point after each test meal.
Measured: Acute response over 2 hours
Postprandial insulinemic response
Compare the postprandial insulin levels at each time point and incremental area under teh curve after each meal.
Measured: Acute response over 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start15 Sep 2021
- Primary completion12 Oct 2021
- Study completion28 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood SugarStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anderson Advanced Ingredients
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- INQUIS Clinical Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05185960
- Sponsor's protocol ID
- INQ-2117
- Status last verified
- Jan 2022
- First submitted
- 23 Dec 2021
- Last updated
- 25 Jan 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 25 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Postprandial Glycemic and Insulinemic Response of ALLSWEET When Taken Alone or When Added to Sucrose: A Randomized, Double Blind, Controlled Clinical Trial in Healthy Individuals
- ClinicalTrials.gov ID
- NCT05185960
- Acronym / sponsor ID
- INQ-2117
- Conditions
- Blood Sugar
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Anderson Advanced IngredientsIndustry (pharma, biotech, devices)
- Collaborators
- INQUIS Clinical Research
- Study start
- 15 Sep 2021 (actual)
- Primary completion
- 12 Oct 2021 (actual)
- Study completion
- 28 Oct 2021 (actual)
- First posted
- 11 Jan 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.
This study will explore the postprandial glycemic response of ALLSWEET®, a non-GMO certified allulose, when consumed alone or with sucrose, compared to the consuming sucrose alone. On 3 separate days, subjects will consume in random order ALLSWEET® alone, ALLSWEET® added to sucrose, or sucrose alone. Blood samples for glucose and insulin analysis with be taken for 2 hours following consumption of the beverages.
Detailed description
Each subject will receive 3 test meals in a double blinded, randomized, crossover fashion.
- Test arm 1: 30g sucrose
- Test arm 2: 30g sucrose + 15g of ALLSWEET®
- Test arm 3: 15g ALLSWEET® All sweeteners will be mixed with 250ml of water.
Eligible subjects will be studied on 3 separate days over a period of 4 weeks or less, with at least 1 day in between test days. A fasting fingerprick blood sample will be collected for glucose and insulin analysis after which the test meal will be administered. Additional fingerprick blood samples will be drawn over the next 2 hours (15', 30', 45', 60', 90' and 120' after the first sip of the test drink).
Power calculation: A sample size of 15 subjects, is sufficient to detect a 25% difference in incremental area under the curve between meals with 80% statistical power.
Statistical Analysis: Incremental area under the curve values, blood glucose and insulin concentrations and increments at each time will be subjected to repeated-measures analysis of variance. After demonstration of significant heterogeneity, the significance of the differences between individual means will be assessed using Tukey's test to adjust for multiple comparisons, with the criterion for significance being two-tailed p<0.05. Means which differ by more than the least significant difference differ significantly.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ALLSWEET® | Experimental | Other: ALLSWEET®ALLSWEET® will be mixed with 250ml of water and an additional 125ml of water. Fingerprick blood samples will be taken for 2 hours following consumption of beverage in order to assess the glycemic response. |
| ALLSWEET® consumed with sucrose | Experimental | Other: ALLSWEET® and sucroseALLSWEET® and sucrose will be mixed with 250ml of water and an additional 125ml of water. Fingerprick blood samples will be taken for 2 hours following consumption of beverage in order to assess the glycemic response. |
| Sucrose | Active comparator | Other: SucroseSucrose will be mixed with 250ml of water and an additional 125ml of water. Fingerprick blood samples will be taken for 2 hours following consumption of beverage in order to assess the glycemic response. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Individuals, 20-70 years of age, inclusive.
- Body mass index (BMI) between 18 and 33 kg/m², inclusive, at screening.
- Willing to maintain habitual diet, physical activity pattern, and body weight throughout the trial.
- Willing to maintain current dietary supplement and non exclusionary medication use throughout the trial.
- Willing to avoid the consumption of alcohol, unusual food intake, unusual physical activity and consumption of any flatulence promoting foods 24h prior to each study visit. Failure to follow will result in rescheduled visit.
Key exclusion criteria (11 listed)
- Failure to meet any one of the inclusion criteria.
- Known history of gastrointestinal disease (e.g., diverticulitis, Crohns disease, coeliac disease etc.), bariatric surgery, AIDS, hepatitis, a history or presence of clinically important endocrine (including Type 1 or Type 2 diabetes mellitus), cardiovascular (including, but not limited to, atherosclerotic disease, history of myocardial infarction, peripheral arterial disease, stroke), pulmonary, or biliary diseases, or any condition which might, in the opinion of the medical director either: 1) make participation dangerous to the subject or to others, or 2) affect the results.
- Use of medications known to influence carbohydrate metabolism, gastrointestinal function or appetite, including, but not limited to adrenergic blockers, diuretics, thiazolidinediones, metformin and systemic corticosteroids within 4 weeks of the screening visit, or any medication which might, in the opinion of the medical director either: 1) make participation dangerous to the subject or to others, or 2) affect the results.
- Major trauma or surgical event within 3 months of screening.
- Unwillingness or inability to comply with the experimental procedures and to follow INQUIS health and safety policies.
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 |
|---|---|---|
| ALLSWEET®ALLSWEET®, is a non-GMO certified allulose developed by the study sponsor. It will be diluted in water. | Other | ALLSWEET® |
| ALLSWEET® and sucroseALLSWEET®, is a non-GMO certified allulose developed by the study sponsor. It will be added to sucrose (table sugar) and diluted in water. | Other | ALLSWEET® consumed with sucrose |
| SucroseTable sugar. It will be consumed by diluting it in water. | Other | Sucrose |
Primary outcome
Postprandial glycemic response
Time frame: Acute response over 2 hours
Compare the postprandial glucose incremental area under the curve response of ALLSWEET® with sucrose when taken alone or when added to sucrose.
2 secondary outcomes
Postprandial glycemic response
Time frame: Acute response over 2 hours
Postprandial insulinemic response
Time frame: Acute response over 2 hours
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 Jan 2022.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ALLSWEET®, ALLSWEET® and sucrose and Sucrose in people with Blood Sugar, run by Anderson Advanced Ingredients at 1 site in Canada.
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 6 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 25 Jan 2022. 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 Canada. 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?
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?
Postprandial glycemic response (time frame: Acute response over 2 hours). 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 Jan 2022.