Ignite Creation Date:
2024-05-06 @ 12:24 PM
Last Modification Date:
2024-10-26 @ 12:58 PM
Study NCT ID:
NCT03755232
Status:
COMPLETED
Last Update Posted:
2019-09-11
First Post:
2018-11-23
Brief Title:
Acute Glycemic and Insulinemic Response of FOSSENCE
Sponsor:
TATA CHEMICALS LTD
Organization:
TATA CHEMICALS LTD
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2019-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Short chain fructooligosaccharide FOS is known as a prebiotic fibernutrient 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 Limiteds 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
FossenceTM is a short chain fructo-oligosaccharide scFOS sweet tasting soluble prebiotic dietary fibre which is produced through Tata Chemicals Limiteds 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
Detailed Description:
BACKGROUND Short chain fructooligosaccharide FOS is known as a prebiotic fibernutrient 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 Limiteds 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 kgm2 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 n25 subjects has 90 power to detect a 22 difference in 2-hour glucose IAUC with 2-tailed p005
Using the t-distribution and assuming an average CV of within-individual variation of 2-hour insulin IAUC values of 25 n25 subjects has 90 power to detect a 24 difference in 2-hour insulin IAUC with 2-tailed p005
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
1 10g of scFOS
2 A negative control water
3 A positive control 10g of dextrose
Phase 2 to assess the glucose and insulin responses to the following test meals
1 50g Dextrose 15g scFOS
2 35g Dextrose 15g scFOS
3 35g Dextrose and
4 50g Dextrose
Phase 3 to assess the glucose and insulin responses to the following test meals
1 50g available carbohydrate avCHO from white bread 15g scFOS
2 35g avCHO from white bread 15g scFOS
3 35g avCHO from white bread and
4 50g of avCHO from white bread
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 Tukeys method with p005 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 p005
OUTCOMES
The primary analysis of each phase will be
Phase 1 to compare the incremental area under the glucose curve elicited by
1 10g of scFOS
2 A negative control water
3 A positive control 10g of dextrose
Phase 2 to compare the incremental areas under the glucose curve elicited by
1 50g Dextrose 15g scFOS
2 35g Dextrose 15g scFOS
3 35g Dextrose and
4 50g Dextrose
Phase 3 to compare the incremental areas under the glucose curve elicited by
1 50g available carbohydrate avCHO from white bread 15g scFOS
2 35g avCHO from white bread 15g scFOS
3 35g avCHO from white bread and
4 50g of avCHO from white bread
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
1 50g available carbohydrate avCHO from white bread 15g scFOS
2 35g avCHO from white bread 15g scFOS
3 35g avCHO from white bread and
4 50g of avCHO from white bread
FossenceTM is short chain fructo-oligosaccharide scFOS a sweet tasting soluble dietary fibre which is produced through Tata Chemicals Limiteds 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 kgm2 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 n25 subjects has 90 power to detect a 22 difference in 2-hour glucose IAUC with 2-tailed p005
Using the t-distribution and assuming an average CV of within-individual variation of 2-hour insulin IAUC values of 25 n25 subjects has 90 power to detect a 24 difference in 2-hour insulin IAUC with 2-tailed p005
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
1 10g of scFOS
2 A negative control water
3 A positive control 10g of dextrose
Phase 2 to assess the glucose and insulin responses to the following test meals
1 50g Dextrose 15g scFOS
2 35g Dextrose 15g scFOS
3 35g Dextrose and
4 50g Dextrose
Phase 3 to assess the glucose and insulin responses to the following test meals
1 50g available carbohydrate avCHO from white bread 15g scFOS
2 35g avCHO from white bread 15g scFOS
3 35g avCHO from white bread and
4 50g of avCHO from white bread
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 Tukeys method with p005 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 p005
OUTCOMES
The primary analysis of each phase will be
Phase 1 to compare the incremental area under the glucose curve elicited by
1 10g of scFOS
2 A negative control water
3 A positive control 10g of dextrose
Phase 2 to compare the incremental areas under the glucose curve elicited by
1 50g Dextrose 15g scFOS
2 35g Dextrose 15g scFOS
3 35g Dextrose and
4 50g Dextrose
Phase 3 to compare the incremental areas under the glucose curve elicited by
1 50g available carbohydrate avCHO from white bread 15g scFOS
2 35g avCHO from white bread 15g scFOS
3 35g avCHO from white bread and
4 50g of avCHO from white bread
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
1 50g available carbohydrate avCHO from white bread 15g scFOS
2 35g avCHO from white bread 15g scFOS
3 35g avCHO from white bread and
4 50g of avCHO from white bread
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None