Prebiotic Effects of Isomalto-oligosaccharide

March 21, 2017 updated by: Cara Frankenfeld, George Mason University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Fairfax, Virginia, United States, 22030
        • George Mason University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
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
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: Supplement A
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
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: Supplement B
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in gut bacterial DNA from baseline, extracted from fecal sample
Time Frame: 4 weeks
4 weeks
Change in gut bacterial DNA from baseline, extracted from fecal sample
Time Frame: 8 Weeks
8 Weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

George Mason University

Investigators

  • Principal Investigator: Cara L Frankenfeld, PhD, George Mason University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

April 25, 2015

First Submitted That Met QC Criteria

May 4, 2015

First Posted (Estimate)

May 5, 2015

Study Record Updates

Last Update Posted (Actual)

March 23, 2017

Last Update Submitted That Met QC Criteria

March 21, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 115796

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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