The Alberta FYBER (Feed Your Gut Bacteria morE fibeR) Study

NCT02322112 | Completed

• 1 other identifier: Pro00050274
• Study Type: interventional
• Target: 195
• Locations: 1 country
• Sites: 1

Brief Summary

Too much body-fat has been linked to a low-grade inflammation throughout the body. This inflammation is thought to then cause different diseases, like heart disease and diabetes. A lower amount of inflammation is usually seen in people that follow a high fiber diet. A reason for this is the microbes that live in our gut. Fiber is a main food source for these microbes. This allows fiber to actually change the type of microbes that live in our gut. Also, when fiber gets fermented by these microbes, health-promoting waste products get released. We aim to determine how exactly our gut microbes contribute to the health properties of fiber. We hypothesize that fiber's health properties depend on how the gut microbes respond to the fiber. To test this, we plan to add three different fibers to the diets of healthy overweight and obese individuals for six weeks. We then will determine how the different fibers affect an individuals' health by looking at how established markers of health change from adding the fiber. Following this, we will see how an individual's gut microbes respond to the added fiber. The response will be decided by looking at changes to the microbe community, as well as their ability to ferment the fibers. By connecting health outcomes to the gut microbes' response, we can test if the gut microbes' response to the fiber determines the fiber's ability to effect health. If we can understand how our gut microbes respond to different fibers and the importance of that response. Then we could personalize diets to have a greater impact on improving health.

Conditions

Overweight and Obesity

Keywords

Dietary Fiber; Gastrointestinal Microbiome; Overweight and Obesity; Personalized Nutrition; Inflammation; Metabolism

Outcome Measures

Primary Outcomes (1)

• Prediction of the Clinical Improvements of Dietary Fiber

  The primary objective of this study is to determine the ability of the fecal microbiome to predict clinical improvements of dietary fiber treatments relevant to the etiology of obesity-associated pathologies.

  6-week period

Secondary Outcomes (6)

• Dietary Fiber Associated Changes in Sub-clinical Inflammation

  6-week period

• Dietary Fiber Associated Changes in Insulin Resistance and Blood Cholesterol.

  6-week period

• Dietary Fiber Associated Changes in Satiety and Dietary Intake.

  6-week period

• Dietary Fiber Associated Changes in Trimethylamine-N-Oxide (TMAO).

  6-week period

• Dietary Fiber Associated Changes in Bile Acid Derivatives.

  6-week period

Study Arms (3)

Microcrystalline Cellulose (Control)

PLACEBO COMPARATOR

Microcrystalline cellulose will be used as a placebo control, as it is known to be an insoluble, non-viscous fiber that is essentially not fermented by the human gut microbiota. However, it is important to note that cellulose does have fermentation potential within the gastrointestinal tract and may be associated with improved health benefits; indicating a role as an active comparator.

Other: Microcrystalline Cellulose Supplementation

Acacia Gum

EXPERIMENTAL

Acacia gum is composed largely of arabinogalactan, and is considered to be a relatively non-viscous, soluble fiber this is highly fermented by the gut microbiota and well tolerated.

Other: Acacia Gum Supplementation

Resistant Starch Type 4

EXPERIMENTAL

Cross-linked phosphorylated resistant starch (type IV) is generally insoluble and with low viscosity; yet it tends to have physiologic properties similar to soluble fibers, such as fermentability.

Other: Resistant Starch Type 4 Supplementation

Interventions

Microcrystalline Cellulose Supplementation OTHER

Fifty overweight and mildly obese subjects will supplement their normal dietary intake with a significant yet tolerable amount of MCC (Females: 25 g; Males: 35 g) daily for six consecutive weeks.

Also known as: Microcel MC-12; Blanver Farmoquímica Ltda.

Microcrystalline Cellulose (Control)

Acacia Gum Supplementation OTHER

Seventy five overweight and mildly obese subjects will supplement their normal dietary intake with a significant yet tolerable amount of AG (Females: 25 g; Males: 35 g) daily for six consecutive weeks.

Also known as: Agri-Spray Acacia Fibre; Agrigum International Ltd.

Acacia Gum

Resistant Starch Type 4 Supplementation OTHER

Seventy five overweight and mildly obese subjects will supplement their normal dietary intake with a significant yet tolerable amount of RS4 (Females: 25 g; Males: 35 g) daily for six consecutive weeks.

Also known as: Fibersym RW; MGP Ingredients, Inc.

Resistant Starch Type 4

Eligibility Criteria

• Age: 19 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• BMI of 25-35
• men and pre-menopausal, non-pregnant or lactating women
• weight stability (±3%) for at least 1 month
• no diagnosis of gastrointestinal disorders or history of gastrointestinal surgical interventions.
• no history of diabetes mellitus

You may not qualify if:

• vegetarian or vegan
• smoking
• alcohol intake greater than 7 drinks per week
• vigorous exercise more than 3 hours per week
• uses supplements (including prebiotics and probiotics)
• antibiotic treatment in the last 3 months
• allergy or intolerance to treatment fibers (wheat or acacia gum)
• use of anti-hypertensive, lipid-lowering, anti-diabetic, anti-inflammatory, or laxative medications

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

Alberta Diabetes Institute Clinical Research Unit

Edmonton, Alberta, T6G 2E1, Canada

Location

Related Publications (13)

• Hajer GR, van Haeften TW, Visseren FL. Adipose tissue dysfunction in obesity, diabetes, and vascular diseases. Eur Heart J. 2008 Dec;29(24):2959-71. doi: 10.1093/eurheartj/ehn387. Epub 2008 Sep 5.

  PMID: 18775919 BACKGROUND

• Tilg H, Kaser A. Gut microbiome, obesity, and metabolic dysfunction. J Clin Invest. 2011 Jun;121(6):2126-32. doi: 10.1172/JCI58109. Epub 2011 Jun 1.

  PMID: 21633181 BACKGROUND

• De Bandt JP, Waligora-Dupriet AJ, Butel MJ. Intestinal microbiota in inflammation and insulin resistance: relevance to humans. Curr Opin Clin Nutr Metab Care. 2011 Jul;14(4):334-40. doi: 10.1097/MCO.0b013e328347924a.

  PMID: 21587065 BACKGROUND

• David LA, Maurice CF, Carmody RN, Gootenberg DB, Button JE, Wolfe BE, Ling AV, Devlin AS, Varma Y, Fischbach MA, Biddinger SB, Dutton RJ, Turnbaugh PJ. Diet rapidly and reproducibly alters the human gut microbiome. Nature. 2014 Jan 23;505(7484):559-63. doi: 10.1038/nature12820. Epub 2013 Dec 11.

  PMID: 24336217 BACKGROUND

• Hamaker BR, Tuncil YE. A perspective on the complexity of dietary fiber structures and their potential effect on the gut microbiota. J Mol Biol. 2014 Nov 25;426(23):3838-50. doi: 10.1016/j.jmb.2014.07.028. Epub 2014 Aug 1.

  PMID: 25088686 BACKGROUND

• King DE, Egan BM, Woolson RF, Mainous AG 3rd, Al-Solaiman Y, Jesri A. Effect of a high-fiber diet vs a fiber-supplemented diet on C-reactive protein level. Arch Intern Med. 2007 Mar 12;167(5):502-6. doi: 10.1001/archinte.167.5.502.

  PMID: 17353499 BACKGROUND

• Ma Y, Hebert JR, Li W, Bertone-Johnson ER, Olendzki B, Pagoto SL, Tinker L, Rosal MC, Ockene IS, Ockene JK, Griffith JA, Liu S. Association between dietary fiber and markers of systemic inflammation in the Women's Health Initiative Observational Study. Nutrition. 2008 Oct;24(10):941-9. doi: 10.1016/j.nut.2008.04.005. Epub 2008 Jun 18.

  PMID: 18562168 BACKGROUND

• Davis LM, Martinez I, Walter J, Hutkins R. A dose dependent impact of prebiotic galactooligosaccharides on the intestinal microbiota of healthy adults. Int J Food Microbiol. 2010 Dec 15;144(2):285-92. doi: 10.1016/j.ijfoodmicro.2010.10.007. Epub 2010 Oct 14.

  PMID: 21059476 BACKGROUND

• Martinez I, Kim J, Duffy PR, Schlegel VL, Walter J. Resistant starches types 2 and 4 have differential effects on the composition of the fecal microbiota in human subjects. PLoS One. 2010 Nov 29;5(11):e15046. doi: 10.1371/journal.pone.0015046.

  PMID: 21151493 BACKGROUND

• Martinez I, Lattimer JM, Hubach KL, Case JA, Yang J, Weber CG, Louk JA, Rose DJ, Kyureghian G, Peterson DA, Haub MD, Walter J. Gut microbiome composition is linked to whole grain-induced immunological improvements. ISME J. 2013 Feb;7(2):269-80. doi: 10.1038/ismej.2012.104. Epub 2012 Oct 4.

  PMID: 23038174 BACKGROUND

• Armet AM, Li F, Deehan EC, Nikolaeva DD, Delannoy-Bruno O, Siegwald L, Berger B, Castelli KM, Rodionov DA, Arzamasov AA, Liu J, Seethaler B, Cole JL, Nguyen KN, Jin M, Zhao YY, Sharma AM, Curtis JM, Proctor SD, Bischoff SC, Wismer WV, Osterman AL, Bakal JA, Greiner R, Field CJ, Knights D, Prado CM, Walter J. Mechanistic insights into microbiome-dependent and personalized responses to dietary fibre in a randomized controlled trial. medRxiv [Preprint]. 2025 Nov 21:2025.11.20.25340625. doi: 10.1101/2025.11.20.25340625.

  PMID: 41332831 DERIVED

• Deehan EC, Zhang Z, Riva A, Armet AM, Perez-Munoz ME, Nguyen NK, Krysa JA, Seethaler B, Zhao YY, Cole J, Li F, Hausmann B, Spittler A, Nazare JA, Delzenne NM, Curtis JM, Wismer WV, Proctor SD, Bakal JA, Bischoff SC, Knights D, Field CJ, Berry D, Prado CM, Walter J. Elucidating the role of the gut microbiota in the physiological effects of dietary fiber. Microbiome. 2022 May 13;10(1):77. doi: 10.1186/s40168-022-01248-5.

  PMID: 35562794 DERIVED

• Nguyen NK, Deehan EC, Zhang Z, Jin M, Baskota N, Perez-Munoz ME, Cole J, Tuncil YE, Seethaler B, Wang T, Laville M, Delzenne NM, Bischoff SC, Hamaker BR, Martinez I, Knights D, Bakal JA, Prado CM, Walter J. Gut microbiota modulation with long-chain corn bran arabinoxylan in adults with overweight and obesity is linked to an individualized temporal increase in fecal propionate. Microbiome. 2020 Aug 19;8(1):118. doi: 10.1186/s40168-020-00887-w.

  PMID: 32814582 DERIVED

MeSH Terms

Conditions

Overweight; Obesity; Inflammation

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Study Officials

• Jens Walter, PhD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2014
• First Posted: December 22, 2014
• Study Start: August 1, 2015
• Primary Completion: April 1, 2020
• Study Completion: April 1, 2020
• Last Updated: May 5, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)