Status:
COMPLETED
Comparison of the Postprandial Glycemic and Insulinemic Response of ALLSWEET When Taken Alone or When Added to Sucrose
Lead Sponsor:
Anderson Advanced Ingredients
Collaborating Sponsors:
INQUIS Clinical Research
Conditions:
Blood Sugar
Eligibility:
All Genders
20-70 years
Phase:
NA
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,...
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 sw...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 28 2021
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT05185960
Start Date
September 15 2021
End Date
October 28 2021
Last Update
January 25 2022
Active Locations (1)
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1
INQUIS Clinical Research
Toronto, Ontario, Canada, M5C 2N8