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

NCT05185960 | Completed

• 1 other identifier: INQ-2117
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Blood Sugar

Outcome Measures

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.

  Acute response over 2 hours

Secondary Outcomes (2)

• Postprandial glycemic response

  Acute response over 2 hours

• Postprandial insulinemic response

  Acute response over 2 hours

Study Arms (3)

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.

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.

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.

Other: Sucrose

Interventions

ALLSWEET® OTHER

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

ALLSWEET®

ALLSWEET® and sucrose OTHER

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

ALLSWEET® consumed with sucrose

Sucrose OTHER

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

Sucrose

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Anderson Advanced Ingredients: lead
• INQUIS Clinical Research: collaborator

Study Sites (1)

INQUIS Clinical Research

Toronto, Ontario, M5C 2N8, Canada

Location

MeSH Terms

Interventions

Sucrose

Intervention Hierarchy (Ancestors)

Disaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Sugars

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2021
• First Posted: January 11, 2022
• Study Start: September 15, 2021
• Primary Completion: October 12, 2021
• Study Completion: October 28, 2021
• Last Updated: January 25, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)