Acute Glycemic and Insulinemic Response of FOSSENCE™

Launched by TATA CHEMICALS LTD · Nov 23, 2018

Keywords

ClinConnect Summary

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 glycemia, gut health, mineral absorption, satiety \& weight management and immunity.

FossenceTM is short chain fructo-oligosaccharide (scFOS), a sweet tasting, soluble dietary fibre which is produced through Tata Chemicals Limited's patented process. These properties of scFOS suggest that the molecule may potentially play a role in glucose and insulin metabolism. The proposed 3 phase study will there...

Gender

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Eligibility criteria

• • 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
• Inclusion Criteria:
• • 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 Criteria:
• • 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