Prebiotic Effects of Isomalto-oligosaccharide

NCT02433873 | Completed

• 1 other identifier: 115796
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

The primary purpose of this study is to evaluate the effect of an IMO nutritional supplement on gut microbiome, gut health, and body weight. Two formulations of the supplement will be evaluated; thus, there will be three study arms: Supplement A, Supplement B, and placebo. Stool samples will be analyzed for bacterial DNA. The gut bacterial DNA, body weight, and gut health data will be compared across supplement and placebo groups. Primary Aim 1: To evaluate the effect of the IMO supplement on gut bacterial abundance, diversity, and gene function across intervention and placebo groups, and across two doses of the intervention. Secondary Aim 1: To evaluate the effect of the IMO supplement on gut health across intervention and placebo groups, and across two doses of the intervention. Secondary Aim 2: To evaluate the effect of the IMO supplement on body weight across intervention and placebo groups, and across two doses of the intervention. 60 subjects, randomized to three arms (20 each: Supplement formula A, Supplement formula B or placebo) will take a daily dose of Supplement A, Supplement B, or placebo for 8 weeks. The supplement is a light syrup liquid. Ingredients that are in the supplement are: isomalto-oligosaccharide, water, mannitol, maltose, glucose, and glycerol. Ingredients that are in the placebo are: high maltose corn syrup (Satin Sweet™), water, and mannitol. Dose will be 500 mg during the first 4 weeks and then 1000 mg for second 4 weeks. Subjects will be instructed to take 500 mg/day of the supplement or placebo the first four weeks and 1000 mg/day of the supplement or placebo for the second four weeks. Subjects will be blinded as to whether they are receiving placebo or supplement. After screening and once enrolled, subject involvement includes visits to George Mason University, being weighed, dropping off stool samples, and completing a survey on gut health. Stool samples will be analyzed for bacterial DNA. The gut bacterial DNA, weight, and gut health data will be compared across supplement and placebo groups.

Conditions

Microbiota

Keywords

Microbiota; Body weight; Digestive system

Outcome Measures

Primary Outcomes (2)

• Change in gut bacterial DNA from baseline, extracted from fecal sample

  4 weeks

• Change in gut bacterial DNA from baseline, extracted from fecal sample

  8 Weeks

Secondary Outcomes (4)

• Body weight change from baseline

  Week 4

• Change from baseline in self-reported digestive health measured by questionnaire

  Week 4

• Change from baseline in self-reported digestive health measured by questionnaire

  Week 8

• Body weight change from baseline

  Week 8

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Ingredients that are in the placebo are: high maltose corn syrup (Satin Sweet™), water, and mannitol. Both Supplement A and Supplement B will be compared to this placebo arm.

Dietary Supplement: Isomalto-oligosaccharide

Supplement A

EXPERIMENTAL

Ingredients that are in the supplement are: isomalto-oligosaccharide, water, mannitol, maltose, glucose, and glycerol. Supplement A and B differ by degrees of polymerization.

Dietary Supplement: Isomalto-oligosaccharide

Supplement B

EXPERIMENTAL

Ingredients that are in the supplement are: isomalto-oligosaccharide, water, mannitol, maltose, glucose, and glycerol. Supplement A and B differ by degrees of polymerization.

Dietary Supplement: Isomalto-oligosaccharide

Interventions

Isomalto-oligosaccharide DIETARY_SUPPLEMENT

Isomalto-oligosaccharide (IMO) is a non-digestible type of oligosaccharide commonly used as a low-calorie sweetener mixed with a variety of other food and beverage products for the purpose of sweetening.

Placebo; Supplement A; Supplement B

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Provide signed and dated informed consent form
• Willing to comply with all study procedures and be available for the duration of the study
• Male or female, aged 18 to 45 years of age
• In good general health as evidenced by medical history
• Women of reproductive potential must use highly effective contraception
• Body mass index of 25 kg/m2 or higher
• Weigh less than 350 lbs.

You may not qualify if:

• History of colon cancer
• History of rheumatoid arthritis
• Active self-reported febrile illness (may enroll after 2-week waiting period following the day that the illness/fever is resolved)
• Taking TNF-alpha inhibitors, COX2 inhibitors, JAK inhibitors
• History of hypothyroidism (with or without treatment)
• History of inflammatory bowel disease (ulcerative colitis and Crohn's disease)
• Type I or Type II diabetes
• History of Parkinson's Disease, Huntington's Disease or Multiple Sclerosis
• History of major depression, bipolar disorder, or schizophrenia
• Pregnant or lactating women
• Currently suffering from migraine headaches (at least one migraine headache in the past 30 days)
• Current use of any prescription or non-prescription weight loss products
• Consumption of more than 2 drinks per day of alcohol
• Tobacco smoker (over ½ pack per week is excluded)
• Marijuana smoker (over once per month is excluded)

Sponsors & Collaborators

• George Mason University: lead

Study Sites (1)

George Mason University

Fairfax, Virginia, 22030, United States

Location

Related Publications (7)

• Thitaram SN, Chung CH, Day DF, Hinton A Jr, Bailey JS, Siragusa GR. Isomaltooligosaccharide increases cecal Bifidobacterium population in young broiler chickens. Poult Sci. 2005 Jul;84(7):998-1003. doi: 10.1093/ps/84.7.998.

  PMID: 16050115 BACKGROUND

• Chung CH, Day DF. Efficacy of Leuconostoc mesenteroides (ATCC 13146) isomaltooligosaccharides as a poultry prebiotic. Poult Sci. 2004 Aug;83(8):1302-6. doi: 10.1093/ps/83.8.1302.

  PMID: 15339004 BACKGROUND

• Chen HL, Lu YH, Lin JJ, Ko LY. Effects of isomalto-oligosaccharides on bowel functions and indicators of nutritional status in constipated elderly men. J Am Coll Nutr. 2001 Feb;20(1):44-9. doi: 10.1080/07315724.2001.10719013.

  PMID: 11294172 BACKGROUND

• Wang HF, Lim PS, Kao MD, Chan EC, Lin LC, Wang NP. Use of isomalto-oligosaccharide in the treatment of lipid profiles and constipation in hemodialysis patients. J Ren Nutr. 2001 Apr;11(2):73-9. doi: 10.1016/s1051-2276(01)92591-9.

  PMID: 11295027 BACKGROUND

• Yen CH, Tseng YH, Kuo YW, Lee MC, Chen HL. Long-term supplementation of isomalto-oligosaccharides improved colonic microflora profile, bowel function, and blood cholesterol levels in constipated elderly people--a placebo-controlled, diet-controlled trial. Nutrition. 2011 Apr;27(4):445-50. doi: 10.1016/j.nut.2010.05.012. Epub 2010 Jul 10.

  PMID: 20624673 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

• Komanduri S, Gillevet PM, Sikaroodi M, Mutlu E, Keshavarzian A. Dysbiosis in pouchitis: evidence of unique microfloral patterns in pouch inflammation. Clin Gastroenterol Hepatol. 2007 Mar;5(3):352-60. doi: 10.1016/j.cgh.2007.01.001.

  PMID: 17368235 BACKGROUND

MeSH Terms

Conditions

Body Weight

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Cara L Frankenfeld, PhD

  George Mason University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 25, 2015
• First Posted: May 5, 2015
• Study Start: April 1, 2015
• Primary Completion: November 1, 2015
• Study Completion: December 1, 2016
• Last Updated: March 23, 2017

Record last verified: 2017-03

Locations

US (1)