Acute Glycemic and Insulinemic Response of FOSSENCE™
Condition: Dietary Modification; Healthy
Study type: Interventional

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.
    

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 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:

        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 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

        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
    

Intervention name(s): scFOS; Control
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Fossence™ (short chain Fructo-oligosaccharides (scFOS); water or dextrose or white bread
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: dietary fibre; fructo-oligosaccharide; prebiotic; glucose metabolism; insulin metabolism