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Acute Glycemic and Insulinemic Response of FOSSENCE™

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ClinicalTrials.gov Identifier: NCT03755232
Recruitment Status : Not yet recruiting
First Posted : November 27, 2018
Last Update Posted : November 29, 2018
Sponsor:
Collaborator:
Glycemic Index Laboratories, Inc
Information provided by (Responsible Party):
TATA CHEMICALS LTD

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 absorption, weight and immunity.

FossenceTM is a short chain fructo-oligosaccharide (scFOS), sweet tasting, soluble prebiotic dietary fibre which is produced through Tata Chemicals Limited's patented process and is currently US GRAS notified (safe for consumption). The formulation and properties of scFOS suggest that the molecule may potentially play a role in glucose and insulin metabolism.

The purpose of this study is to explore the rise of glucose and insulin in the blood after consuming FossenceTM that has been added or substituted into a sugar drink or white bread.


Condition or disease Intervention/treatment Phase
Dietary Modification Healthy Dietary Supplement: scFOS Other: Control Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Determination of the Acute Glycemic and Insulinemic Response of FOSSENCE™ Alone, or When Substituted or Added to a Carbohydrate Challenge: A Three-phase, Acute, Randomized, Cross-over, Double Blind Clinical Trial
Estimated Study Start Date : December 1, 2018
Estimated Primary Completion Date : September 1, 2019
Estimated Study Completion Date : December 1, 2019

Arm Intervention/treatment
Experimental: scFOS treatment #1
Phase 1: 10g of scFOS Phase 2: 50g dextrose +15g scFOS Phase 3: 50g avCHO from white bread +15g scFOS
Dietary Supplement: scFOS
Fossence™ (short chain Fructo-oligosaccharides (scFOS)

Experimental: scFOS treatment #2
Phase 1: n/a Phase 2: 35g Dextrose +15g scFOS Phase 3: 35g avCHO from white bread +15g scFOS
Dietary Supplement: scFOS
Fossence™ (short chain Fructo-oligosaccharides (scFOS)

Active Comparator: Control #1
Phase 1: Water control (negative control) Phase 2: 35g Dextrose control 1 Phase 3: 35g avCHO from white bread (control 1)
Other: Control
water or dextrose or white bread

Active Comparator: Control #2
Phase 1: 10g Dextrose (positive control) Phase 2: 50g Dextrose control 2 Phase 3: 50g avCHO from white bread (control 2)
Other: Control
water or dextrose or white bread




Primary Outcome Measures :
  1. incremental area under the 2 hour (120 minutes) blood glucose curve [ Time Frame: 0-120 minutes ]
    The mean glucose concentration in the 2 fasting blood samples will be used as the fasting concentration for the purposes of calculating incremental area under the glucose response curve (IAUC), ignoring area below fasting


Secondary Outcome Measures :
  1. incremental area under the 2 hour (120 minutes) blood insulin curve [ Time Frame: 0-120 minutes ]
    The mean insulin concentration in the 2 fasting blood samples will be used as the fasting concentration for the purposes of calculating incremental area under the insulin response curve (IAUC), ignoring area below fasting

  2. comparison of the glucose and insulin levels at individual time points from 0-120min [ Time Frame: 0-120 minutes ]
    to compare the glucose and insulin levels at individual time points (at -fasting, 15, 30, 45, 60, 90 and 120 min (7 time points)



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03755232


Contacts
Contact: Thomas MS Wolever, MD 416-978-5556 twolever@gilabs.com

Sponsors and Collaborators
TATA CHEMICALS LTD
Glycemic Index Laboratories, Inc
Investigators
Principal Investigator: Thomas MS Wolever, MD Glycemic Index Laboratories, Inc

Publications:
Sheth M, Thakuria A, Chand V and Paban Nath M. Fructooligosaccharide (fos)- a smart strategy to modulate inflammatory marker and lipid profile in non-insulin dependent diabetes mellitus (NIDDM) subjects residing in Assam, India- a randomized control trial. World J Pharma Res, 2015; 4 (5): 2673-2678
Yamashita K, Kawai K, Itakura M. Effects of fructo-oligosaccharides on blood glucose and serum lipids in diabetic subjects. Nutr Res, 1984; 4(6):961-6.

Responsible Party: TATA CHEMICALS LTD
ClinicalTrials.gov Identifier: NCT03755232     History of Changes
Other Study ID Numbers: GIL-1841Tata
First Posted: November 27, 2018    Key Record Dates
Last Update Posted: November 29, 2018
Last Verified: November 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by TATA CHEMICALS LTD:
dietary fibre
fructo-oligosaccharide
prebiotic
glucose metabolism
insulin metabolism