An interventional study of scFOS and Control in Dietary Modification and Healthy, sponsored by TATA CHEMICALS LTD. Completed at 1 site in Canada. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-09-11.
Sponsored by TATA CHEMICALS LTD · Not applicable, Interventional, and Prevention
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.
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 therefore explore the properties of FossenceTM with respect to its fibre like properties (not digested in the human small intestine), and its effect on postprandial glycemia when added or substituted into a simple (dextrose) or complex (white bread) carbohydrate load.
OBJECTIVES The purpose of this 3 phase study is to: 1. Demonstrate that consumption of scFOS does not increase postprandial blood glucose levels, 2. Explore the effects when scFOS is either added or substituted into a simple carbohydrate load (dextrose) or 3. Into a complex carbohydrate food (white bread).
PARTICIPANTS Twenty five healthy adult males and non-pregnant, non-lactating females, aged 18-65 years with BMI between 18 and 30 kg/m2 are required for each phase.
DESIGN The study is a double-blind, randomized, cross-over trial.
POWER CALCULATION Using the t-distribution and assuming an average coefficient of variation (CV) of within-individual variation of 2-hour glucose incremental are under the curve (IAUC) values of 23%, n=25 subjects has 90% power to detect a 22% difference in 2-hour glucose IAUC with 2-tailed p\<0.05.
Using the t-distribution and assuming an average CV of within-individual variation of 2-hour insulin IAUC values of 25%, n=25 subjects has 90% power to detect a 24% difference in 2-hour insulin IAUC with 2-tailed p\<0.05.
RECRUITMENT Participants will be recruited from the pool of participants at Glycemic Index Laboratories (GI Labs) who have indicated that they are willing to be contacted and asked if they wish to participate in new studies. If an insufficient number of subjects can be recruited, then an advertisement will be used to recruit new subjects.
INTERVENTIONS
Phase 1: to assess the glucose and insulin responses to the following test meals:
Phase 2: to assess the glucose and insulin responses to the following test meals:
Phase 3: to assess the glucose and insulin responses to the following test meals:
STATISTICAL ANALYSIS
For each study phase the following will be the statistical method:
Data will be presented as mean, standard deviation (SD) and standard error of the mean (SEM) values.
The mean glucose or insulin concentration in the 2 fasting blood samples will be used as the fasting concentration for the purposes of calculating incremental areas under the glucose and serum insulin response curves (IAUC), ignoring area below fasting17. Glucose and insulin concentrations, glucose and insulin IAUC (from 0 to 120 minutes) will be subjected to repeated measures analysis using the General Linear Model of variance (GLM-ANOVA). After demonstration of significant heterogeneity, the significance of differences among individual means will be determined using Tukey's method with p\<0.05. In addition, differences at individual time points for glucose and insulin will be assessed. Differences will be considered to be statistically significant if 2-tailed p\<0.05.
OUTCOMES
The primary analysis of each phase will be:
Phase 1: to compare the incremental area under the glucose curve elicited by
Phase 2: to compare the incremental areas under the glucose curve elicited by
Phase 3: to compare the incremental areas under the glucose curve elicited by
The secondary analyses of each phase will be:
Phase 1: to compare the glucose and insulin levels at individual time points, and the incremental area under the serum insulin curve elicited by 10g of scFOS with a negative control (water) or positive control (10g of dextrose)
Phase 2: to compare the glucose and insulin levels at individual time points, and the incremental area under the serum insulin curve elicited by:
(4) 50g Dextrose +15g scFOS, (5) 35g Dextrose +15g scFOS, (6) 35g Dextrose and (7) 50g Dextrose.
Phase 3: to compare the glucose and insulin levels at individual time points and the incremental area under the serum insulin curve elicited by:
This is the only study on the registry with TATA CHEMICALS LTD as lead sponsor.
Counted across the registry records on this site, refreshed daily.
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:
Exclusion Criteria:
Phase 1: 10g of scFOS Phase 2: 50g dextrose +15g scFOS Phase 3: 50g avCHO from white bread +15g scFOS
Dietary Supplement: scFOS
Phase 1: n/a Phase 2: 35g Dextrose +15g scFOS Phase 3: 35g avCHO from white bread +15g scFOS
Dietary Supplement: scFOS
Phase 1: Water control (negative control) Phase 2: 35g Dextrose control 1 Phase 3: 35g avCHO from white bread (control 1)
Other: Control
Phase 1: 10g Dextrose (positive control) Phase 2: 50g Dextrose control 2 Phase 3: 50g avCHO from white bread (control 2)
Other: Control
Fossence™ (short chain Fructo-oligosaccharides (scFOS)
water or dextrose or white bread
incremental area under the 2 hour (120 minutes) blood glucose curve
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
Time frame: 0-120 minutes
incremental area under the 2 hour (120 minutes) blood insulin curve
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
Time frame: 0-120 minutes
comparison of the glucose and insulin levels at individual time points from 0-120min
to compare the glucose and insulin levels at individual time points (at -fasting, 15, 30, 45, 60, 90 and 120 min (7 time points)
Time frame: 0-120 minutes
This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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