Clinical trial NCT02433873: Prebiotic Effects of Isomalto-oligosaccharide
Official title: Prebiotic Effects of Isomalto-oligosaccharide
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Microbiota
Keywords: Microbiota
Body weight
Digestive system
Lead sponsor: George Mason University
Sponsor class: OTHER
First posted: 2015-05-05
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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)
* Currently have an eating disorder including anorexia nervosa, bulimia, and/or obsessive compulsive disorders
* Plan to start a new diet or make changes to their current diet during the study
* Diagnosis of Coronary Artery Disease who have had chest pain within the past 2 months
* Diagnosis of Congestive Heart Failure who have had any episodes of shortness of breath within the last 2 months
* History of stroke within the past 1 year
* History of ventricular tachycardia or fibrillation
* History of hypertension that has been difficult to control with medication (based on medical history - e.g. requiring more than 2 medication to achieve control)
* History of seizures in the last 5 years
* Cancer diagnosis in the last 5 years (except non-melanoma skin cancer or in-situ cervical cancer)
* History of bariatric or lapband surgery
* Usual or planned consumption of more than 2 servings per week of yogurt, kombucha, kefir, or kimichi
* Regular use of antibiotics
* Use of antibiotics in the previous 2 weeks
* Current and continued use of prebiotics or probiotics
* Known allergic reactions to components of the study supplement or placebo

Primary outcomes:
measure: Change in gut bacterial DNA from baseline, extracted from fecal sample
timeFrame: 4 weeks
measure: Change in gut bacterial DNA from baseline, extracted from fecal sample
timeFrame: 8 Weeks
Secondary outcomes:
measure: Body weight change from baseline
timeFrame: Week 4
measure: Change from baseline in self-reported digestive health measured by questionnaire
timeFrame: Week 4
measure: Change from baseline in self-reported digestive health measured by questionnaire
timeFrame: Week 8
measure: Body weight change from baseline
timeFrame: Week 8
Other outcomes:
Locations:
city: Fairfax
country: United States
facility: George Mason University
state: Virginia
Study officials:
affiliation: George Mason University
name: Cara L Frankenfeld, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.