Overview

This trial is active, not recruiting.

Condition microbiota
Treatment isomalto-oligosaccharide
Sponsor George Mason University
Start date April 2015
End date November 2015
Trial size 54 participants
Trial identifier NCT02433873, 115796

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose basic science
Arm
(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.
isomalto-oligosaccharide
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.
(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.
isomalto-oligosaccharide
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.
(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.
isomalto-oligosaccharide
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.

Primary Outcomes

Measure
Change in gut bacterial DNA from baseline, extracted from fecal sample
time frame: 4 weeks
Change in gut bacterial DNA from baseline, extracted from fecal sample
time frame: 8 Weeks

Secondary Outcomes

Measure
Body weight change from baseline
time frame: Week 4
Change from baseline in self-reported digestive health measured by questionnaire
time frame: Week 4
Change from baseline in self-reported digestive health measured by questionnaire
time frame: Week 8
Body weight change from baseline
time frame: Week 8

Eligibility Criteria

Male or female participants from 18 years up to 45 years old.

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

Additional Information

Official title Prebiotic Effects of Isomalto-oligosaccharide
Principal investigator Cara L Frankenfeld, PhD
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by George Mason University.