<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03755232</url>
  </required_header>
  <id_info>
    <org_study_id>GIL-1841Tata</org_study_id>
    <nct_id>NCT03755232</nct_id>
  </id_info>
  <brief_title>Acute Glycemic and Insulinemic Response of FOSSENCE™</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>TATA CHEMICALS LTD</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Glycemic Index Laboratories, Inc</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>TATA CHEMICALS LTD</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Short chain fructooligosaccharide (FOS) is known as a prebiotic fiber/nutrient and has been&#xD;
      documented to demonstrate different health benefits including glucose control, gut health,&#xD;
      mineral absorption, weight and immunity.&#xD;
&#xD;
      FossenceTM is a short chain fructo-oligosaccharide (scFOS), sweet tasting, soluble prebiotic&#xD;
      dietary fibre which is produced through Tata Chemicals Limited's patented process and is&#xD;
      currently US GRAS notified (safe for consumption). The formulation and properties of scFOS&#xD;
      suggest that the molecule may potentially play a role in glucose and insulin metabolism.&#xD;
&#xD;
      The purpose of this study is to explore the rise of glucose and insulin in the blood after&#xD;
      consuming FossenceTM that has been added or substituted into a sugar drink or white bread.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      BACKGROUND Short chain fructooligosaccharide (FOS) is known as a prebiotic fiber/nutrient and&#xD;
      has been documented to demonstrate different health benefits including attenuation of&#xD;
      postprandial glycemia, gut health, mineral absorption, satiety &amp; weight management and&#xD;
      immunity.&#xD;
&#xD;
      FossenceTM is short chain fructo-oligosaccharide (scFOS), a sweet tasting, soluble dietary&#xD;
      fibre which is produced through Tata Chemicals Limited's patented process. These properties&#xD;
      of scFOS suggest that the molecule may potentially play a role in glucose and insulin&#xD;
      metabolism. The proposed 3 phase study will therefore explore the properties of FossenceTM&#xD;
      with respect to its fibre like properties (not digested in the human small intestine), and&#xD;
      its effect on postprandial glycemia when added or substituted into a simple (dextrose) or&#xD;
      complex (white bread) carbohydrate load.&#xD;
&#xD;
      OBJECTIVES The purpose of this 3 phase study is to: 1. Demonstrate that consumption of scFOS&#xD;
      does not increase postprandial blood glucose levels, 2. Explore the effects when scFOS is&#xD;
      either added or substituted into a simple carbohydrate load (dextrose) or 3. Into a complex&#xD;
      carbohydrate food (white bread).&#xD;
&#xD;
      PARTICIPANTS Twenty five healthy adult males and non-pregnant, non-lactating females, aged&#xD;
      18-65 years with BMI between 18 and 30 kg/m2 are required for each phase.&#xD;
&#xD;
      DESIGN The study is a double-blind, randomized, cross-over trial.&#xD;
&#xD;
      POWER CALCULATION Using the t-distribution and assuming an average coefficient of variation&#xD;
      (CV) of within-individual variation of 2-hour glucose incremental are under the curve (IAUC)&#xD;
      values of 23%, n=25 subjects has 90% power to detect a 22% difference in 2-hour glucose IAUC&#xD;
      with 2-tailed p&lt;0.05.&#xD;
&#xD;
      Using the t-distribution and assuming an average CV of within-individual variation of 2-hour&#xD;
      insulin IAUC values of 25%, n=25 subjects has 90% power to detect a 24% difference in 2-hour&#xD;
      insulin IAUC with 2-tailed p&lt;0.05.&#xD;
&#xD;
      RECRUITMENT Participants will be recruited from the pool of participants at Glycemic Index&#xD;
      Laboratories (GI Labs) who have indicated that they are willing to be contacted and asked if&#xD;
      they wish to participate in new studies. If an insufficient number of subjects can be&#xD;
      recruited, then an advertisement will be used to recruit new subjects.&#xD;
&#xD;
      INTERVENTIONS&#xD;
&#xD;
      Phase 1: to assess the glucose and insulin responses to the following test meals:&#xD;
&#xD;
        1. 10g of scFOS&#xD;
&#xD;
        2. A negative control (water)&#xD;
&#xD;
        3. A positive control (10g of dextrose)&#xD;
&#xD;
      Phase 2: to assess the glucose and insulin responses to the following test meals:&#xD;
&#xD;
        1. 50g Dextrose +15g scFOS,&#xD;
&#xD;
        2. 35g Dextrose +15g scFOS,&#xD;
&#xD;
        3. 35g Dextrose and&#xD;
&#xD;
        4. 50g Dextrose.&#xD;
&#xD;
      Phase 3: to assess the glucose and insulin responses to the following test meals:&#xD;
&#xD;
        1. 50g available carbohydrate (avCHO) from white bread +15g scFOS,&#xD;
&#xD;
        2. 35g avCHO from white bread +15g scFOS,&#xD;
&#xD;
        3. 35g avCHO from white bread and&#xD;
&#xD;
        4. 50g of avCHO from white bread&#xD;
&#xD;
      STATISTICAL ANALYSIS&#xD;
&#xD;
      For each study phase the following will be the statistical method:&#xD;
&#xD;
      Data will be presented as mean, standard deviation (SD) and standard error of the mean (SEM)&#xD;
      values.&#xD;
&#xD;
      The mean glucose or insulin concentration in the 2 fasting blood samples will be used as the&#xD;
      fasting concentration for the purposes of calculating incremental areas under the glucose and&#xD;
      serum insulin response curves (IAUC), ignoring area below fasting17. Glucose and insulin&#xD;
      concentrations, glucose and insulin IAUC (from 0 to 120 minutes) will be subjected to&#xD;
      repeated measures analysis using the General Linear Model of variance (GLM-ANOVA). After&#xD;
      demonstration of significant heterogeneity, the significance of differences among individual&#xD;
      means will be determined using Tukey's method with p&lt;0.05. In addition, differences at&#xD;
      individual time points for glucose and insulin will be assessed. Differences will be&#xD;
      considered to be statistically significant if 2-tailed p&lt;0.05.&#xD;
&#xD;
      OUTCOMES&#xD;
&#xD;
      The primary analysis of each phase will be:&#xD;
&#xD;
      Phase 1: to compare the incremental area under the glucose curve elicited by&#xD;
&#xD;
        1. 10g of scFOS&#xD;
&#xD;
        2. A negative control (water)&#xD;
&#xD;
        3. A positive control (10g of dextrose)&#xD;
&#xD;
      Phase 2: to compare the incremental areas under the glucose curve elicited by&#xD;
&#xD;
        1. 50g Dextrose +15g scFOS,&#xD;
&#xD;
        2. 35g Dextrose +15g scFOS,&#xD;
&#xD;
        3. 35g Dextrose and&#xD;
&#xD;
        4. 50g Dextrose.&#xD;
&#xD;
      Phase 3: to compare the incremental areas under the glucose curve elicited by&#xD;
&#xD;
        1. 50g available carbohydrate (avCHO) from white bread +15g scFOS,&#xD;
&#xD;
        2. 35g avCHO from white bread +15g scFOS,&#xD;
&#xD;
        3. 35g avCHO from white bread and&#xD;
&#xD;
        4. 50g of avCHO from white bread&#xD;
&#xD;
      The secondary analyses of each phase will be:&#xD;
&#xD;
      Phase 1: to compare the glucose and insulin levels at individual time points, and the&#xD;
      incremental area under the serum insulin curve elicited by 10g of scFOS with a negative&#xD;
      control (water) or positive control (10g of dextrose)&#xD;
&#xD;
      Phase 2: to compare the glucose and insulin levels at individual time points, and the&#xD;
      incremental area under the serum insulin curve elicited by:&#xD;
&#xD;
      (4) 50g Dextrose +15g scFOS, (5) 35g Dextrose +15g scFOS, (6) 35g Dextrose and (7) 50g&#xD;
      Dextrose.&#xD;
&#xD;
      Phase 3: to compare the glucose and insulin levels at individual time points and the&#xD;
      incremental area under the serum insulin curve elicited by:&#xD;
&#xD;
        1. 50g available carbohydrate (avCHO) from white bread +15g scFOS,&#xD;
&#xD;
        2. 35g avCHO from white bread +15g scFOS,&#xD;
&#xD;
        3. 35g avCHO from white bread and&#xD;
&#xD;
        4. 50g of avCHO from white bread&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 6, 2018</start_date>
  <completion_date type="Actual">September 9, 2019</completion_date>
  <primary_completion_date type="Actual">February 27, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>incremental area under the 2 hour (120 minutes) blood glucose curve</measure>
    <time_frame>0-120 minutes</time_frame>
    <description>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</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>incremental area under the 2 hour (120 minutes) blood insulin curve</measure>
    <time_frame>0-120 minutes</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>comparison of the glucose and insulin levels at individual time points from 0-120min</measure>
    <time_frame>0-120 minutes</time_frame>
    <description>to compare the glucose and insulin levels at individual time points (at -fasting, 15, 30, 45, 60, 90 and 120 min (7 time points)</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">25</enrollment>
  <condition>Dietary Modification</condition>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>scFOS treatment #1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Phase 1: 10g of scFOS Phase 2: 50g dextrose +15g scFOS Phase 3: 50g avCHO from white bread +15g scFOS</description>
  </arm_group>
  <arm_group>
    <arm_group_label>scFOS treatment #2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Phase 1: n/a Phase 2: 35g Dextrose +15g scFOS Phase 3: 35g avCHO from white bread +15g scFOS</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control #1</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Phase 1: Water control (negative control) Phase 2: 35g Dextrose control 1 Phase 3: 35g avCHO from white bread (control 1)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control #2</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Phase 1: 10g Dextrose (positive control) Phase 2: 50g Dextrose control 2 Phase 3: 50g avCHO from white bread (control 2)</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>scFOS</intervention_name>
    <description>Fossence™ (short chain Fructo-oligosaccharides (scFOS)</description>
    <arm_group_label>scFOS treatment #1</arm_group_label>
    <arm_group_label>scFOS treatment #2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Control</intervention_name>
    <description>water or dextrose or white bread</description>
    <arm_group_label>Control #1</arm_group_label>
    <arm_group_label>Control #2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Subjects (N= 25) will be men (at least N= 12) and non-pregnant, non-lactating women (at&#xD;
        least N= 12), 18 - 65 years of age each with a BMI of 18 - 30 kg/m2 inclusive and&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  Blood pressure &lt; 140/90 mmHg&#xD;
&#xD;
          -  No major illness or surgery requiring hospitalization within 3 months of the first&#xD;
             study visit after screening&#xD;
&#xD;
          -  No history of cardiovascular, metabolic, respiratory, renal, gastrointestinal or&#xD;
             hepatic disease&#xD;
&#xD;
          -  Subject may be a male or a non-pregnant, non-lactating female, at least 6 weeks&#xD;
             postpartum prior to screening visit&#xD;
&#xD;
          -  Willing to maintain habitual diet, physical activity pattern, and body weight&#xD;
             throughout the study&#xD;
&#xD;
          -  Subjects must be eligible to receive income in Canada and must demonstrate Ontario&#xD;
             Health Insurance Program coverage&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Failure to meet all the inclusion criteria&#xD;
&#xD;
          -  Previous bariatric procedure&#xD;
&#xD;
          -  No chronic disease such as type-1 or type-2 diabetes mellitus (fasting blood sugar&#xD;
             levels &lt;100 mg/dL (or &lt;5.6 mmol/L) as assessed at the first visit)&#xD;
&#xD;
          -  No gastro-intestinal disorder such as Crohn's disease, coeliac disease, irritable&#xD;
             bowel syndrome&#xD;
&#xD;
          -  Medications known to affect glucose tolerance -but stable doses of oral&#xD;
             contraceptives, acetylsalicylic acid, thyroxin, vitamins and mineral supplements or&#xD;
             drugs to treat hypertension, hyperlipidemia, anxiety/depression or osteoporosis are&#xD;
             acceptable&#xD;
&#xD;
          -  Any known food allergies or intolerances&#xD;
&#xD;
          -  No strong dislike of or intolerance to sweetened beverages or inulin&#xD;
&#xD;
          -  Smokers&#xD;
&#xD;
          -  Alcohol consumption of no more than 10 drinks per week for women and 15 drinks per&#xD;
             week for men. One drink is defined as either 5oz wine, 341ml of beer/cider or 1.5 oz&#xD;
             distilled alcohol&#xD;
&#xD;
          -  History of cancer in the prior two years, except for non-melanoma skin cancer&#xD;
&#xD;
          -  Participants who do not understand English&#xD;
&#xD;
          -  Presence of any condition, illness or drug use, which in the opinion of Dr. Wolever,&#xD;
             increases the risk to the subject or to others or may affect the results&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Thomas MS Wolever, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Glycemic Index Laboratories, Inc</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>INQUIS Clinical Research (formerly GI Labs)</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5C 2N8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <reference>
    <citation>Bouhnik Y, Raskine L, Simoneau G, Paineau D, Bornet F. The capacity of short-chain fructo-oligosaccharides to stimulate faecal bifidobacteria: a dose-response relationship study in healthy humans. Nutr J. 2006 Mar 28;5:8. doi: 10.1186/1475-2891-5-8.</citation>
    <PMID>16569219</PMID>
  </reference>
  <reference>
    <citation>Bouhnik Y, Raskine L, Simoneau G, Vicaut E, Neut C, Flourie B, Brouns F, Bornet FR. The capacity of nondigestible carbohydrates to stimulate fecal bifidobacteria in healthy humans: a double-blind, randomized, placebo-controlled, parallel-group, dose-response relation study. Am J Clin Nutr. 2004 Dec;80(6):1658-64. doi: 10.1093/ajcn/80.6.1658.</citation>
    <PMID>15585783</PMID>
  </reference>
  <reference>
    <citation>Du H, van der A DL, Boshuizen HC, Forouhi NG, Wareham NJ, Halkjaer J, Tjonneland A, Overvad K, Jakobsen MU, Boeing H, Buijsse B, Masala G, Palli D, Sorensen TI, Saris WH, Feskens EJ. Dietary fiber and subsequent changes in body weight and waist circumference in European men and women. Am J Clin Nutr. 2010 Feb;91(2):329-36. doi: 10.3945/ajcn.2009.28191. Epub 2009 Dec 16.</citation>
    <PMID>20016015</PMID>
  </reference>
  <reference>
    <citation>Gordon M, Naidoo K, Akobeng AK, Thomas AG. Cochrane Review: Osmotic and stimulant laxatives for the management of childhood constipation (Review). Evid Based Child Health. 2013 Jan;8(1):57-109. doi: 10.1002/ebch.1893.</citation>
    <PMID>23878124</PMID>
  </reference>
  <reference>
    <citation>Lecerf JM, Clerc E, Jaruga A, Wagner A, Respondek F. Postprandial glycaemic and insulinaemic responses in adults after consumption of dairy desserts and pound cakes containing short-chain fructo-oligosaccharides used to replace sugars. J Nutr Sci. 2015 Oct 12;4:e34. doi: 10.1017/jns.2015.22. eCollection 2015.</citation>
    <PMID>26495125</PMID>
  </reference>
  <reference>
    <citation>Liu S, Willett WC, Manson JE, Hu FB, Rosner B, Colditz G. Relation between changes in intakes of dietary fiber and grain products and changes in weight and development of obesity among middle-aged women. Am J Clin Nutr. 2003 Nov;78(5):920-7. doi: 10.1093/ajcn/78.5.920.</citation>
    <PMID>14594777</PMID>
  </reference>
  <reference>
    <citation>Meksawan K, Chaotrakul C, Leeaphorn N, Gonlchanvit S, Eiam-Ong S, Kanjanabuch T. Effects of Fructo-Oligosaccharide Supplementation on Constipation in Elderly Continuous Ambulatory Peritoneal Dialysis Patients. Perit Dial Int. 2016 Jan-Feb;36(1):60-6. doi: 10.3747/pdi.2014.00015. Epub 2014 Oct 7.</citation>
    <PMID>25292404</PMID>
  </reference>
  <reference>
    <citation>Nakamura Y, Nosaka S, Suzuki M, Nagafuchi S, Takahashi T, Yajima T, Takenouchi-Ohkubo N, Iwase T, Moro I. Dietary fructooligosaccharides up-regulate immunoglobulin A response and polymeric immunoglobulin receptor expression in intestines of infant mice. Clin Exp Immunol. 2004 Jul;137(1):52-8. doi: 10.1111/j.1365-2249.2004.02487.x.</citation>
    <PMID>15196243</PMID>
  </reference>
  <reference>
    <citation>Slavin J. Fiber and prebiotics: mechanisms and health benefits. Nutrients. 2013 Apr 22;5(4):1417-35. doi: 10.3390/nu5041417.</citation>
    <PMID>23609775</PMID>
  </reference>
  <reference>
    <citation>van den Heuvel EG, Muijs T, Brouns F, Hendriks HF. Short-chain fructo-oligosaccharides improve magnesium absorption in adolescent girls with a low calcium intake. Nutr Res. 2009 Apr;29(4):229-37. doi: 10.1016/j.nutres.2009.03.005.</citation>
    <PMID>19410973</PMID>
  </reference>
  <reference>
    <citation>van den Heuvel EG, Muys T, van Dokkum W, Schaafsma G. Oligofructose stimulates calcium absorption in adolescents. Am J Clin Nutr. 1999 Mar;69(3):544-8. doi: 10.1093/ajcn/69.3.544.</citation>
    <PMID>10075343</PMID>
  </reference>
  <reference>
    <citation>Vandenplas Y, Zakharova I, Dmitrieva Y. Oligosaccharides in infant formula: more evidence to validate the role of prebiotics. Br J Nutr. 2015 May 14;113(9):1339-44. doi: 10.1017/S0007114515000823.</citation>
    <PMID>25989994</PMID>
  </reference>
  <reference>
    <citation>Ye EQ, Chacko SA, Chou EL, Kugizaki M, Liu S. Greater whole-grain intake is associated with lower risk of type 2 diabetes, cardiovascular disease, and weight gain. J Nutr. 2012 Jul;142(7):1304-13. doi: 10.3945/jn.111.155325. Epub 2012 May 30. Erratum In: J Nutr. 2013 Sep;143(9):1524.</citation>
    <PMID>22649266</PMID>
  </reference>
  <reference>
    <citation>Jenkins AL, Kacinik V, Lyon MR, Wolever TM. Reduction of postprandial glycemia by the novel viscous polysaccharide PGX, in a dose-dependent manner, independent of food form. J Am Coll Nutr. 2010 Apr;29(2):92-8. doi: 10.1080/07315724.2010.10719821.</citation>
    <PMID>20679143</PMID>
  </reference>
  <reference>
    <citation>Wolever TM, Jenkins DJ, Jenkins AL, Josse RG. The glycemic index: methodology and clinical implications. Am J Clin Nutr. 1991 Nov;54(5):846-54. doi: 10.1093/ajcn/54.5.846.</citation>
    <PMID>1951155</PMID>
  </reference>
  <reference>
    <citation>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</citation>
  </reference>
  <reference>
    <citation>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.</citation>
  </reference>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>November 23, 2018</study_first_submitted>
  <study_first_submitted_qc>November 23, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 27, 2018</study_first_posted>
  <last_update_submitted>September 9, 2019</last_update_submitted>
  <last_update_submitted_qc>September 9, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 11, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>dietary fibre</keyword>
  <keyword>fructo-oligosaccharide</keyword>
  <keyword>prebiotic</keyword>
  <keyword>glucose metabolism</keyword>
  <keyword>insulin metabolism</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03755232
org study id: GIL-1841Tata
nct id: NCT03755232
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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:

        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
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: incremental area under the 2 hour (120 minutes) blood glucose curve
time frame: 0-120 minutes
description: 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
measure: incremental area under the 2 hour (120 minutes) blood insulin curve
time frame: 0-120 minutes
description: 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
measure: comparison of the glucose and insulin levels at individual time points from 0-120min
time frame: 0-120 minutes
description: to compare the glucose and insulin levels at individual time points (at -fasting, 15, 30, 45, 60, 90 and 120 min (7 time points)
arm group label: scFOS treatment #1
arm group type: Experimental
description: Phase 1: 10g of scFOS Phase 2: 50g dextrose +15g scFOS Phase 3: 50g avCHO from white bread +15g scFOS
arm group label: scFOS treatment #2
arm group type: Experimental
description: Phase 1: n/a Phase 2: 35g Dextrose +15g scFOS Phase 3: 35g avCHO from white bread +15g scFOS
arm group label: Control #1
arm group type: Active Comparator
description: Phase 1: Water control (negative control) Phase 2: 35g Dextrose control 1 Phase 3: 35g avCHO from white bread (control 1)
arm group label: Control #2
arm group type: Active Comparator
description: Phase 1: 10g Dextrose (positive control) Phase 2: 50g Dextrose control 2 Phase 3: 50g avCHO from white bread (control 2)
intervention type: Dietary Supplement
intervention name: scFOS
description: Fossence™ (short chain Fructo-oligosaccharides (scFOS)
arm group label: scFOS treatment #1
arm group label: scFOS treatment #2
intervention type: Other
intervention name: Control
description: water or dextrose or white bread
arm group label: Control #1
arm group label: Control #2
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Thomas MS Wolever, MD
role: Principal Investigator
affiliation: Glycemic Index Laboratories, Inc
facility: 
country: Canada
citation: Bouhnik Y, Raskine L, Simoneau G, Paineau D, Bornet F. The capacity of short-chain fructo-oligosaccharides to stimulate faecal bifidobacteria: a dose-response relationship study in healthy humans. Nutr J. 2006 Mar 28;5:8. doi: 10.1186/1475-2891-5-8.
PMID: 16569219
citation: Bouhnik Y, Raskine L, Simoneau G, Vicaut E, Neut C, Flourie B, Brouns F, Bornet FR. The capacity of nondigestible carbohydrates to stimulate fecal bifidobacteria in healthy humans: a double-blind, randomized, placebo-controlled, parallel-group, dose-response relation study. Am J Clin Nutr. 2004 Dec;80(6):1658-64. doi: 10.1093/ajcn/80.6.1658.
PMID: 15585783
citation: Du H, van der A DL, Boshuizen HC, Forouhi NG, Wareham NJ, Halkjaer J, Tjonneland A, Overvad K, Jakobsen MU, Boeing H, Buijsse B, Masala G, Palli D, Sorensen TI, Saris WH, Feskens EJ. Dietary fiber and subsequent changes in body weight and waist circumference in European men and women. Am J Clin Nutr. 2010 Feb;91(2):329-36. doi: 10.3945/ajcn.2009.28191. Epub 2009 Dec 16.
PMID: 20016015
citation: Gordon M, Naidoo K, Akobeng AK, Thomas AG. Cochrane Review: Osmotic and stimulant laxatives for the management of childhood constipation (Review). Evid Based Child Health. 2013 Jan;8(1):57-109. doi: 10.1002/ebch.1893.
PMID: 23878124
citation: Lecerf JM, Clerc E, Jaruga A, Wagner A, Respondek F. Postprandial glycaemic and insulinaemic responses in adults after consumption of dairy desserts and pound cakes containing short-chain fructo-oligosaccharides used to replace sugars. J Nutr Sci. 2015 Oct 12;4:e34. doi: 10.1017/jns.2015.22. eCollection 2015.
PMID: 26495125
citation: Liu S, Willett WC, Manson JE, Hu FB, Rosner B, Colditz G. Relation between changes in intakes of dietary fiber and grain products and changes in weight and development of obesity among middle-aged women. Am J Clin Nutr. 2003 Nov;78(5):920-7. doi: 10.1093/ajcn/78.5.920.
PMID: 14594777
citation: Meksawan K, Chaotrakul C, Leeaphorn N, Gonlchanvit S, Eiam-Ong S, Kanjanabuch T. Effects of Fructo-Oligosaccharide Supplementation on Constipation in Elderly Continuous Ambulatory Peritoneal Dialysis Patients. Perit Dial Int. 2016 Jan-Feb;36(1):60-6. doi: 10.3747/pdi.2014.00015. Epub 2014 Oct 7.
PMID: 25292404
citation: Nakamura Y, Nosaka S, Suzuki M, Nagafuchi S, Takahashi T, Yajima T, Takenouchi-Ohkubo N, Iwase T, Moro I. Dietary fructooligosaccharides up-regulate immunoglobulin A response and polymeric immunoglobulin receptor expression in intestines of infant mice. Clin Exp Immunol. 2004 Jul;137(1):52-8. doi: 10.1111/j.1365-2249.2004.02487.x.
PMID: 15196243
citation: Slavin J. Fiber and prebiotics: mechanisms and health benefits. Nutrients. 2013 Apr 22;5(4):1417-35. doi: 10.3390/nu5041417.
PMID: 23609775
citation: van den Heuvel EG, Muijs T, Brouns F, Hendriks HF. Short-chain fructo-oligosaccharides improve magnesium absorption in adolescent girls with a low calcium intake. Nutr Res. 2009 Apr;29(4):229-37. doi: 10.1016/j.nutres.2009.03.005.
PMID: 19410973
citation: van den Heuvel EG, Muys T, van Dokkum W, Schaafsma G. Oligofructose stimulates calcium absorption in adolescents. Am J Clin Nutr. 1999 Mar;69(3):544-8. doi: 10.1093/ajcn/69.3.544.
PMID: 10075343
citation: Vandenplas Y, Zakharova I, Dmitrieva Y. Oligosaccharides in infant formula: more evidence to validate the role of prebiotics. Br J Nutr. 2015 May 14;113(9):1339-44. doi: 10.1017/S0007114515000823.
PMID: 25989994
citation: Ye EQ, Chacko SA, Chou EL, Kugizaki M, Liu S. Greater whole-grain intake is associated with lower risk of type 2 diabetes, cardiovascular disease, and weight gain. J Nutr. 2012 Jul;142(7):1304-13. doi: 10.3945/jn.111.155325. Epub 2012 May 30. Erratum In: J Nutr. 2013 Sep;143(9):1524.
PMID: 22649266
citation: Jenkins AL, Kacinik V, Lyon MR, Wolever TM. Reduction of postprandial glycemia by the novel viscous polysaccharide PGX, in a dose-dependent manner, independent of food form. J Am Coll Nutr. 2010 Apr;29(2):92-8. doi: 10.1080/07315724.2010.10719821.
PMID: 20679143
citation: Wolever TM, Jenkins DJ, Jenkins AL, Josse RG. The glycemic index: methodology and clinical implications. Am J Clin Nutr. 1991 Nov;54(5):846-54. doi: 10.1093/ajcn/54.5.846.
PMID: 1951155
citation: 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
citation: 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 type: Sponsor