Dietary ModificationNCT03755232
Acute Glycemic and Insulinemic Response of FOSSENCE™
A study testing scFOS in people with Dietary Modification and Healthy, run by TATA CHEMICALS LTD at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Dietary Modification, Healthy
- What is being tested?
- scFOS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteCanada
- Study dates
- 6 Dec 2018to 9 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
INQUIS Clinical Research (formerly GI Labs)
Toronto, Ontario, M5C 2N8
About this study
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
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.
Read the 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:
- 10g of scFOS
- A negative control (water)
- A positive control (10g of dextrose)
Phase 2: to assess the glucose and insulin responses to the following test meals:
- 50g Dextrose +15g scFOS,
- 35g Dextrose +15g scFOS,
- 35g Dextrose and
- 50g Dextrose.
Phase 3: to assess the glucose and insulin responses to the following test meals:
- 50g available carbohydrate (avCHO) from white bread +15g scFOS,
- 35g avCHO from white bread +15g scFOS,
- 35g avCHO from white bread and
- 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
- 10g of scFOS
- A negative control (water)
- A positive control (10g of dextrose)
Phase 2: to compare the incremental areas under the glucose curve elicited by
- 50g Dextrose +15g scFOS,
- 35g Dextrose +15g scFOS,
- 35g Dextrose and
- 50g Dextrose.
Phase 3: to compare the incremental areas under the glucose curve elicited by
- 50g available carbohydrate (avCHO) from white bread +15g scFOS,
- 35g avCHO from white bread +15g scFOS,
- 35g avCHO from white bread and
- 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:
- 50g available carbohydrate (avCHO) from white bread +15g scFOS,
- 35g avCHO from white bread +15g scFOS,
- 35g avCHO from white bread and
- 50g of avCHO from white bread
- Conditions
- Dietary Modification, Healthy
- Being tested
- scFOS, Control
- Keywords
- dietary fibre, fructo-oligosaccharide, prebiotic, glucose metabolism, insulin metabolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
scFOSDietary supplement
Fossence™ (short chain Fructo-oligosaccharides (scFOS)
ControlOther
water or dextrose or white bread
| Study group | Role | What they receive |
|---|---|---|
| scFOS treatment #1 | Experimental | Phase 1: 10g of scFOS Phase 2: 50g dextrose +15g scFOS Phase 3: 50g avCHO from white bread +15g scFOS Receives: Dietary Supplement: scFOS |
| scFOS treatment #2 | Experimental | Phase 1: n/a Phase 2: 35g Dextrose +15g scFOS Phase 3: 35g avCHO from white bread +15g scFOS Receives: Dietary Supplement: scFOS |
| Control #1 | Active comparator | Phase 1: Water control (negative control) Phase 2: 35g Dextrose control 1 Phase 3: 35g avCHO from white bread (control 1) Receives: Other: Control |
| Control #2 | Active comparator | Phase 1: 10g Dextrose (positive control) Phase 2: 50g Dextrose control 2 Phase 3: 50g avCHO from white bread (control 2) Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 0-120 minutes
Secondary outcomes (2)
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
Measured: 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)
Measured: 0-120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2018
- Study start6 Dec 2018
- Primary completion27 Feb 2019
- Study completion9 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Dietary ModificationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- TATA CHEMICALS LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Glycemic Index Laboratories, Inc
- Responsible party
- Sponsor
- Investigators
- Thomas MS Wolever, MD, Principal investigator, Glycemic Index Laboratories, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03755232
- Sponsor's protocol ID
- GIL-1841Tata
- Status last verified
- Sep 2019
- First submitted
- 23 Nov 2018
- Last updated
- 11 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 16569219Bouhnik 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.
PubMed 15585783Du 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.
PubMed 20016015Gordon 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.
PubMed 23878124Lecerf 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.
PubMed 26495125Liu 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.
PubMed 14594777Meksawan 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.
PubMed 25292404Nakamura 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.
PubMed 15196243Slavin J. Fiber and prebiotics: mechanisms and health benefits. Nutrients. 2013 Apr 22;5(4):1417-35. doi: 10.3390/nu5041417.
PubMed 23609775van 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.
PubMed 19410973van 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.
PubMed 10075343Vandenplas 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.
PubMed 25989994Ye 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.
PubMed 22649266Jenkins 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.
PubMed 20679143Wolever 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.
PubMed 1951155
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03755232
- Acronym / sponsor ID
- GIL-1841Tata
- Conditions
- Dietary Modification, Healthy
- Keywords
- dietary fibre, fructo-oligosaccharide, prebiotic, glucose metabolism, insulin metabolism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- TATA CHEMICALS LTDIndustry (pharma, biotech, devices)
- Collaborators
- Glycemic Index Laboratories, Inc
- Study start
- 6 Dec 2018 (actual)
- Primary completion
- 27 Feb 2019 (actual)
- Study completion
- 9 Sep 2019 (actual)
- First posted
- 27 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 10g of scFOS
- A negative control (water)
- A positive control (10g of dextrose)
Phase 2: to assess the glucose and insulin responses to the following test meals:
- 50g Dextrose +15g scFOS,
- 35g Dextrose +15g scFOS,
- 35g Dextrose and
- 50g Dextrose.
Phase 3: to assess the glucose and insulin responses to the following test meals:
- 50g available carbohydrate (avCHO) from white bread +15g scFOS,
- 35g avCHO from white bread +15g scFOS,
- 35g avCHO from white bread and
- 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
- 10g of scFOS
- A negative control (water)
- A positive control (10g of dextrose)
Phase 2: to compare the incremental areas under the glucose curve elicited by
- 50g Dextrose +15g scFOS,
- 35g Dextrose +15g scFOS,
- 35g Dextrose and
- 50g Dextrose.
Phase 3: to compare the incremental areas under the glucose curve elicited by
- 50g available carbohydrate (avCHO) from white bread +15g scFOS,
- 35g avCHO from white bread +15g scFOS,
- 35g avCHO from white bread and
- 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:
- 50g available carbohydrate (avCHO) from white bread +15g scFOS,
- 35g avCHO from white bread +15g scFOS,
- 35g avCHO from white bread and
- 50g of avCHO from white bread
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| scFOS treatment #1 | Experimental | Dietary Supplement: scFOSPhase 1: 10g of scFOS Phase 2: 50g dextrose +15g scFOS Phase 3: 50g avCHO from white bread +15g scFOS |
| scFOS treatment #2 | Experimental | Dietary Supplement: scFOSPhase 1: n/a Phase 2: 35g Dextrose +15g scFOS Phase 3: 35g avCHO from white bread +15g scFOS |
| Control #1 | Active comparator | Other: ControlPhase 1: Water control (negative control) Phase 2: 35g Dextrose control 1 Phase 3: 35g avCHO from white bread (control 1) |
| Control #2 | Active comparator | Other: ControlPhase 1: 10g Dextrose (positive control) Phase 2: 50g Dextrose control 2 Phase 3: 50g avCHO from white bread (control 2) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| scFOSFossence™ (short chain Fructo-oligosaccharides (scFOS) | Dietary supplement | scFOS treatment #1, scFOS treatment #2 |
| Controlwater or dextrose or white bread | Other | Control #1, Control #2 |
Primary outcome
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
2 secondary outcomes
incremental area under the 2 hour (120 minutes) blood insulin curve
Time frame: 0-120 minutes
comparison of the glucose and insulin levels at individual time points from 0-120min
Time frame: 0-120 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2019.
- Background: PubMed 16569219Bouhnik 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.
- Background: PubMed 15585783Bouhnik 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.
- Background: PubMed 20016015Du 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.
- Background: PubMed 23878124Gordon 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.
- Background: PubMed 26495125Lecerf 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas MS Wolever, MD principal investigator
Glycemic Index Laboratories, Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing scFOS in people with Dietary Modification and Healthy, run by TATA CHEMICALS LTD at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incremental area under the 2 hour (120 minutes) blood glucose curve (time frame: 0-120 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03755232, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2019.