Prebiotic Effects of Isomalto-oligosaccharide

Study Overview
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Brief Summary
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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.

Official Title
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Prebiotic Effects of Isomalto-oligosaccharide

Conditions
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Microbiota

Intervention / Treatment
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* Dietary Supplement: Isomalto-oligosaccharide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>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<br>* 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.<br>|
| Experimental: Supplement A<br>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<br>* 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.<br>|
| Experimental: Supplement B<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Microbiota, Body weight, Digestive system