Status:
COMPLETED
Acute Glycemic and Insulinemic Response of FOSSENCE™
Lead Sponsor:
TATA CHEMICALS LTD
Collaborating Sponsors:
Glycemic Index Laboratories, Inc
Conditions:
Dietary Modification
Healthy
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Short chain fructooligosaccharide (FOS) is known as a prebiotic fiber/nutrient and has been documented to demonstrate different health benefits including glucose control, gut health, mineral absorptio...
Detailed Description
BACKGROUND Short chain fructooligosaccharide (FOS) is known as a prebiotic fiber/nutrient and has been documented to demonstrate different health benefits including attenuation of postprandial glycemi...
Eligibility Criteria
Inclusion
- Subjects (N= 25) will be men (at least N= 12) and non-pregnant, non-lactating women (at least N= 12), 18 - 65 years of age each with a BMI of 18 - 30 kg/m2 inclusive and
- Blood pressure \< 140/90 mmHg
- No major illness or surgery requiring hospitalization within 3 months of the first study visit after screening
- No history of cardiovascular, metabolic, respiratory, renal, gastrointestinal or hepatic disease
- Subject may be a male or a non-pregnant, non-lactating female, at least 6 weeks postpartum prior to screening visit
- Willing to maintain habitual diet, physical activity pattern, and body weight throughout the study
- Subjects must be eligible to receive income in Canada and must demonstrate Ontario Health Insurance Program coverage
Exclusion
- Failure to meet all the inclusion criteria
- Previous bariatric procedure
- No chronic disease such as type-1 or type-2 diabetes mellitus (fasting blood sugar levels \<100 mg/dL (or \<5.6 mmol/L) as assessed at the first visit)
- No gastro-intestinal disorder such as Crohn's disease, coeliac disease, irritable bowel syndrome
- Medications known to affect glucose tolerance -but stable doses of oral contraceptives, acetylsalicylic acid, thyroxin, vitamins and mineral supplements or drugs to treat hypertension, hyperlipidemia, anxiety/depression or osteoporosis are acceptable
- Any known food allergies or intolerances
- No strong dislike of or intolerance to sweetened beverages or inulin
- Smokers
- Alcohol consumption of no more than 10 drinks per week for women and 15 drinks per week for men. One drink is defined as either 5oz wine, 341ml of beer/cider or 1.5 oz distilled alcohol
- History of cancer in the prior two years, except for non-melanoma skin cancer
- Participants who do not understand English
- Presence of any condition, illness or drug use, which in the opinion of Dr. Wolever, increases the risk to the subject or to others or may affect the results
Key Trial Info
Start Date :
December 6 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 9 2019
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT03755232
Start Date
December 6 2018
End Date
September 9 2019
Last Update
September 11 2019
Active Locations (1)
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1
INQUIS Clinical Research (formerly GI Labs)
Toronto, Ontario, Canada, M5C 2N8