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Prebiotic Effects of Isomalto-oligosaccharide

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ClinicalTrials.gov Identifier: NCT02433873
Recruitment Status : Completed
First Posted : May 5, 2015
Last Update Posted : March 23, 2017
Sponsor:
Information provided by (Responsible Party):
Cara Frankenfeld, George Mason University

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.


Condition or disease Intervention/treatment Phase
Microbiota Dietary Supplement: Isomalto-oligosaccharide Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Prebiotic Effects of Isomalto-oligosaccharide
Study Start Date : April 2015
Actual Primary Completion Date : November 2015
Actual Study Completion Date : December 2016

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.




Primary Outcome Measures :
  1. Change in gut bacterial DNA from baseline, extracted from fecal sample [ Time Frame: 4 weeks ]
  2. Change in gut bacterial DNA from baseline, extracted from fecal sample [ Time Frame: 8 Weeks ]

Secondary Outcome Measures :
  1. Body weight change from baseline [ Time Frame: Week 4 ]
  2. Change from baseline in self-reported digestive health measured by questionnaire [ Time Frame: Week 4 ]
  3. Change from baseline in self-reported digestive health measured by questionnaire [ Time Frame: Week 8 ]
  4. Body weight change from baseline [ Time Frame: Week 8 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02433873


Locations
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United States, Virginia
George Mason University
Fairfax, Virginia, United States, 22030
Sponsors and Collaborators
George Mason University
Investigators
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Principal Investigator: Cara L Frankenfeld, PhD George Mason University

Publications:

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Responsible Party: Cara Frankenfeld, Assistant Professor, George Mason University
ClinicalTrials.gov Identifier: NCT02433873     History of Changes
Other Study ID Numbers: 115796
First Posted: May 5, 2015    Key Record Dates
Last Update Posted: March 23, 2017
Last Verified: March 2017

Keywords provided by Cara Frankenfeld, George Mason University:
Microbiota
Body weight
Digestive system