MicrobiotaNCT02433873
Prebiotic Effects of Isomalto-oligosaccharide
A study testing Isomalto-oligosaccharide in people with Microbiota, run by George Mason University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Microbiota
- What is being tested?
- Isomalto-oligosaccharide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2015to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 30Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Conditions
- Microbiota
- Being tested
- Isomalto-oligosaccharide
- Keywords
- Microbiota, Body weight, Digestive system
- Medical subject headings
- Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isomalto-oligosaccharideDietary supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | 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. Receives: Dietary Supplement: Isomalto-oligosaccharide |
| Supplement A | 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. Receives: Dietary Supplement: Isomalto-oligosaccharide |
| Supplement B | 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. Receives: Dietary Supplement: Isomalto-oligosaccharide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in gut bacterial DNA from baseline, extracted from fecal sample
Measured: 4 weeks
Change in gut bacterial DNA from baseline, extracted from fecal sample
Measured: 8 Weeks
Secondary outcomes (4)
Body weight change from baseline
Measured: Week 4
Change from baseline in self-reported digestive health measured by questionnaire
Measured: Week 4
Change from baseline in self-reported digestive health measured by questionnaire
Measured: Week 8
Body weight change from baseline
Measured: Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2015 (estimated)
- Study startApr 2015
- Primary completionNov 2015
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for MicrobiotaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- George Mason University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cara Frankenfeld, George Mason University
- Investigators
- Cara L Frankenfeld, PhD, Principal investigator, George Mason University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02433873
- Sponsor's protocol ID
- 115796
- Status last verified
- Mar 2017
- First submitted
- 25 Apr 2015
- Last updated
- 23 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 16050115Chung 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.
PubMed 15339004Chen 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.
PubMed 11294172Wang 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.
PubMed 11295027Yen 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.
PubMed 20624673Davis 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.
PubMed 21059476Komanduri 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.
PubMed 17368235
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prebiotic Effects of Isomalto-oligosaccharide
- ClinicalTrials.gov ID
- NCT02433873
- Acronym / sponsor ID
- 115796
- Conditions
- Microbiota
- Keywords
- Microbiota, Body weight, Digestive system
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- George Mason UniversityUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 5 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Isomalto-oligosaccharideIngredients 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. |
| Supplement A | Experimental | Dietary Supplement: Isomalto-oligosaccharideIngredients that are in the supplement are: isomalto-oligosaccharide, water, mannitol, maltose, glucose, and glycerol. Supplement A and B differ by degrees of polymerization. |
| Supplement B | Experimental | Dietary Supplement: Isomalto-oligosaccharideIngredients that are in the supplement are: isomalto-oligosaccharide, water, mannitol, maltose, glucose, and glycerol. Supplement A and B differ by degrees of polymerization. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (30 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Isomalto-oligosaccharideIsomalto-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. | Dietary supplement | Placebo, Supplement A, Supplement B |
Primary outcome
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
4 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2017.
- Background: PubMed 16050115Thitaram 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.
- Background: PubMed 15339004Chung 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.
- Background: PubMed 11294172Chen 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.
- Background: PubMed 11295027Wang 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.
- Background: PubMed 20624673Yen 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.
- Background: PubMed 21059476Davis 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.
- Background: PubMed 17368235Komanduri 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cara L Frankenfeld, PhD principal investigator
George Mason University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Isomalto-oligosaccharide in people with Microbiota, run by George Mason University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in gut bacterial DNA from baseline, extracted from fecal sample (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02433873, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2017.