Acute Glycemic and Insulinemic Response of FOSSENCE™

NCT03755232 | Completed

• 1 other identifier: GIL-1841Tata
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dietary Modification; Healthy

Keywords

dietary fibre; fructo-oligosaccharide; prebiotic; glucose metabolism; insulin metabolism

Outcome Measures

Primary Outcomes (1)

• 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

  0-120 minutes

Secondary Outcomes (2)

• incremental area under the 2 hour (120 minutes) blood insulin curve

  0-120 minutes

• comparison of the glucose and insulin levels at individual time points from 0-120min

  0-120 minutes

Study Arms (4)

scFOS treatment #1

EXPERIMENTAL

Phase 1: 10g of scFOS Phase 2: 50g dextrose +15g scFOS Phase 3: 50g avCHO from white bread +15g scFOS

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

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)

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)

Other: Control

Interventions

scFOS DIETARY_SUPPLEMENT

Fossence™ (short chain Fructo-oligosaccharides (scFOS)

scFOS treatment #1; scFOS treatment #2

Control OTHER

water or dextrose or white bread

Control #1; Control #2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• TATA CHEMICALS LTD: lead
• Glycemic Index Laboratories, Inc: collaborator

Study Sites (1)

INQUIS Clinical Research (formerly GI Labs)

Toronto, Ontario, M5C 2N8, Canada

Location

Related Publications (18)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Slavin J. Fiber and prebiotics: mechanisms and health benefits. Nutrients. 2013 Apr 22;5(4):1417-35. doi: 10.3390/nu5041417.

  PMID: 23609775 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 22649266 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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

  BACKGROUND

• 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.

  BACKGROUND

• Shah P, Wolever TM, Jenkins AL, Ezatagha A, Campbell J, Zurbau A, Jain M, Gote M, Bhaduri A, Mullick A. Acute glycemic and insulin response of Fossence alone, or when substituted or added to a carbohydrate challenge: A three-phase, acute, randomized, cross-over, double blind clinical trial. Heliyon. 2021 Apr 28;7(4):e06805. doi: 10.1016/j.heliyon.2021.e06805. eCollection 2021 Apr.

  PMID: 33997376 DERIVED

Study Officials

• Thomas MS Wolever, MD

  Glycemic Index Laboratories, Inc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2018
• First Posted: November 27, 2018
• Study Start: December 6, 2018
• Primary Completion: February 27, 2019
• Study Completion: September 9, 2019
• Last Updated: September 11, 2019

Record last verified: 2019-09

Locations

CA (1)