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CompletedNCT05185960Updated Jan 25, 2022

Comparison of the Postprandial Glycemic and Insulinemic Response of ALLSWEET When Taken Alone or When Added to Sucrose

An interventional study of ALLSWEET® and ALLSWEET® and sucrose in Blood Sugar, sponsored by Anderson Advanced Ingredients. Completed at 1 site in Canada. Open to participants aged 20 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-01-25.

Sponsored by Anderson Advanced Ingredients · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Sep 2021, registered Dec 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
15
Allocation
Randomized
Ages
20 Years to 70 Years
Sex
All
01

Study 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. 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.

  1. Test arm 1: 30g sucrose
  2. Test arm 2: 30g sucrose + 15g of ALLSWEET®
  3. 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.

02

Conditions studied

  • Blood Sugar
03

In context

Lead sponsor

Anderson Advanced Ingredients is the lead sponsor of 2 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
15 participants (actual)

Study arms

  • Experimental
    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.

    Other: ALLSWEET®

  • Experimental
    ALLSWEET® consumed with sucrose

    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.

    Other: ALLSWEET® and sucrose

  • Active comparator
    Sucrose

    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.

    Other: Sucrose

Interventions

  • OtherALLSWEET®

    ALLSWEET®, is a non-GMO certified allulose developed by the study sponsor. It will be diluted in water.

  • OtherALLSWEET® and sucrose

    ALLSWEET®, is a non-GMO certified allulose developed by the study sponsor. It will be added to sucrose (table sugar) and diluted in water.

  • OtherSucrose

    Table sugar. It will be consumed by diluting it in water.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Acute response over 2 hours

Secondary outcomes

  1. Postprandial glycemic response

    Compare the postprandial glucose levels at each time point after each test meal.

    Time frame: Acute response over 2 hours

  2. Postprandial insulinemic response

    Compare the postprandial insulin levels at each time point and incremental area under teh curve after each meal.

    Time frame: Acute response over 2 hours

07

Study locations

1 site
  • INQUIS Clinical Research
    Toronto, Ontario M5C 2N8, Canada
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 25, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05185960
Lead sponsor
Anderson Advanced Ingredients
Collaborators
INQUIS Clinical Research
Responsible party
Sponsor
First posted
Jan 11, 2022
Start date
Sep 15, 2021
Primary completion
Oct 12, 2021
Completion
Oct 28, 2021
Last update
Jan 25, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.

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