HealthyPhase 1NCT01462331
the Dietary Effects of VitaSugar/VitaFiber-IMO in Healthy Adults
A Phase 1 study testing Isomaltooligosaccharide (digestion-resistant carbohydrates) and Sucrose in people with Healthy, run by BioNeutra Inc. at 1 site in Canada.
Trial summary
The purpose of this study is to re-confirm the already established health effects and dose tolerance of Isomalto-oligosaccharide or IMO, which is a general health/functional food ingredient. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Isomaltooligosaccharide (digestion-resistant carbohydrates) and Sucrose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2010to Dec 2011
- Phase
- Phase 1
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Women who are pregnant, breastfeeding, or planning to become pregnant during the course of the trial
- Participation in a clinical research trial within 30 days prior to randomization
- History of or current diagnosis of any cancer (except for successfully treated basal cell carcinoma) diagnosed less than 5 years prior to screening. Subjects with cancer in full remission more than 5 years after diagnosis are acceptable.
- Uncontrolled hypertension defined as untreated systolic blood pressure > 160 mmHg and/or diastolic blood pressure > 100 mmHg or the use of medication for the treatment of hypertension
- Unstable medications (dosage must be stable for 90 days prior to randomization
- Clinically significant abnormal laboratory results at screening
Show all 13Show fewer
- History of gastrointestinal disease (appendectomy is acceptable) or diabetes
- Use of antibiotics and/or laxatives within 2 months prior to randomization
- Use of food or supplements containing probiotics within 2 weeks prior to randomization and during the course of the study
- Alcohol or drug abuse in past year
- Allergy or sensitivity to test product ingredients
- Individuals who are cognitively impaired and/or who are unable to give informed consent
- Any other condition which in the Investigator's opinion may adversely affect the subject's ability to complete the study or its measures or which may pose significant risk to the subject Concomitant Medications Subjects will be required to washout for 14 days after taking any food or supplements containing probiotics before they can be randomized if the investigator determines that this will not negatively affect the subject's health. Subjects requiring prescribed medications for any acute or chronic conditions will be not be allowed to participate in this trial. Subjects cannot have used antibiotics or laxatives within the 2 months prior to randomization. Birth control is allowed during the study. Subjects who are currently taking prescribed birth control must agree to maintain their current method and dosing regimen during the course of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Double-blind, Randomized, Placebo Controlled Study to Investigate the Dietary Effects of VitaSugar/VitaFiber-IMO in Healthy Adults
The purpose of this study is to re-confirm the already established health effects and dose tolerance of Isomalto-oligosaccharide or IMO, which is a general health/functional food ingredient.
Read the detailed description
Isomalto-oligosaccharide (IMO) is a mixture of natural resistant carbohydrates consisting of short-chains of glucose molecules. IMO is made by enzymatic conversion of starch and uses as a health food ingredient with health benefits of a low calorie sweetener, prebiotic and dietary fiber. IMO have been ingested by humans for last many centuries as it is naturally found in rice miso, sake and soy sauce. IMO already got approval from FDA (GRAS) and from Health Canada.
There are number of published studies (in humans and animals) regarding the health benefits of IMO as an effective prebiotic, and its role in improving overall human gastric health. Studies also showed that IMO have found to be most tolerable with least adverse effects compared to other short-chain resistant oligosaccharides. Current clinical studies are conducted to verify the above given health benefits in BioNeutra's manufactured VitaSugar/VitaFiber-IMO products which including quantitative analysis of Bifidobacteria spp., Lactic acid bacteria group and clostridium spp. The production of short-chain fatty-acids (SCFA) and effect on blood glucose level are also analyzed in addition to the dose tolerance in term of lower and upper permissible dosage with resultant adverse effects if any are also observed.
- Conditions
- Healthy
- Being tested
- Isomaltooligosaccharide (digestion-resistant carbohydrates), Sucrose
- Keywords
- Isomaltooligosaccharide, Human Consumption, Dose tolerance, Prebiotic, Short chain fatty acids, Blood glucose, Dose tolerance and prebiotic effect
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isomaltooligosaccharide (digestion-resistant carbohydrates)Other
Also called VitaSugar, VitaFiber
12g/dose; three times a day
Isomaltooligosaccharide (digestion-resistant carbohydrates)Other
Also called VitaSugar, VitaFiber
18g/dose, three times a day
SucroseOther
Also called Table top sugar
12g/dose, three times a day
| Study group | Role | What they receive |
|---|---|---|
| VitaSugar/VitaFiber-IMO dose-1 | Other | A group of 20 subjects (10 male and 10 females) will take IMO dose-1 (12g/dose) powder; three times a day dissolved in a glass of water Receives: Other: Isomaltooligosaccharide (digestion-resistant carbohydrates) |
| VitaSugar/VitaFiber-IMO dose-2 | Other | A group of 20 subjects (10 male and 10 females) will take IMO dose-2 (18g/dose) powder; three times a day dissolved in a glass of water Receives: Other: Isomaltooligosaccharide (digestion-resistant carbohydrates) |
| Placebo | Placebo comparator | A group of 20 subjects (10 male and 10 females) will take Placebo (12g/dose) powder; three times a day dissolved in a glass of water Receives: Other: Sucrose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Tolerance
To Evalaute the dietary effects of two dosages of VitaSugar/VitaFiber-IMO on digestive health in healthy adults.
Measured: one year
Secondary outcomes (1)
Effect of IMO on human colon microflora and clinical chemistry
To evaluate effect of VitaSugar/VitaFiber-IMO on human colon microflora and clinical chemistry, including: Prebiotic effect, Quantitative analysis of fecal samples for SCFA, Analysis of Glucose and insulin level and general clinical chemistry.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2011 (estimated)
- Study startNov 2010
- Primary completionNov 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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 1
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioNeutra Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Alberta Agriculture and Rural Development
- Responsible party
- Sponsor
- Investigators
- Mal Evans, PhD, Principal investigator, KGK Synergize
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01462331
- Sponsor's protocol ID
- 11VBHB
- Status last verified
- Jul 2012
- First submitted
- 27 Oct 2011
- Last updated
- 26 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind, Randomized, Placebo Controlled Study to Investigate the Dietary Effects of VitaSugar/VitaFiber-IMO in Healthy Adults
- ClinicalTrials.gov ID
- NCT01462331
- Acronym / sponsor ID
- 11VBHB
- Conditions
- Healthy
- Keywords
- Isomaltooligosaccharide, Human Consumption, Dose tolerance, Prebiotic, Short chain fatty acids, Blood glucose, Dose tolerance and prebiotic effect
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- BioNeutra Inc.University, hospital or other
- Collaborators
- Alberta Agriculture and Rural Development
- Study start
- Nov 2010
- Primary completion
- Nov 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 31 Oct 2011 (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 purpose of this study is to re-confirm the already established health effects and dose tolerance of Isomalto-oligosaccharide or IMO, which is a general health/functional food ingredient.
Detailed description
Isomalto-oligosaccharide (IMO) is a mixture of natural resistant carbohydrates consisting of short-chains of glucose molecules. IMO is made by enzymatic conversion of starch and uses as a health food ingredient with health benefits of a low calorie sweetener, prebiotic and dietary fiber. IMO have been ingested by humans for last many centuries as it is naturally found in rice miso, sake and soy sauce. IMO already got approval from FDA (GRAS) and from Health Canada.
There are number of published studies (in humans and animals) regarding the health benefits of IMO as an effective prebiotic, and its role in improving overall human gastric health. Studies also showed that IMO have found to be most tolerable with least adverse effects compared to other short-chain resistant oligosaccharides. Current clinical studies are conducted to verify the above given health benefits in BioNeutra's manufactured VitaSugar/VitaFiber-IMO products which including quantitative analysis of Bifidobacteria spp., Lactic acid bacteria group and clostridium spp. The production of short-chain fatty-acids (SCFA) and effect on blood glucose level are also analyzed in addition to the dose tolerance in term of lower and upper permissible dosage with resultant adverse effects if any are also observed.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| VitaSugar/VitaFiber-IMO dose-1 | Other | Other: Isomaltooligosaccharide (digestion-resistant carbohydrates)A group of 20 subjects (10 male and 10 females) will take IMO dose-1 (12g/dose) powder; three times a day dissolved in a glass of water |
| VitaSugar/VitaFiber-IMO dose-2 | Other | Other: Isomaltooligosaccharide (digestion-resistant carbohydrates)A group of 20 subjects (10 male and 10 females) will take IMO dose-2 (18g/dose) powder; three times a day dissolved in a glass of water |
| Placebo | Placebo comparator | Other: SucroseA group of 20 subjects (10 male and 10 females) will take Placebo (12g/dose) powder; three times a day dissolved in a glass of water |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (13 listed)
- Women who are pregnant, breastfeeding, or planning to become pregnant during the course of the trial
- Participation in a clinical research trial within 30 days prior to randomization
- History of or current diagnosis of any cancer (except for successfully treated basal cell carcinoma) diagnosed less than 5 years prior to screening. Subjects with cancer in full remission more than 5 years after diagnosis are acceptable.
- Uncontrolled hypertension defined as untreated systolic blood pressure > 160 mmHg and/or diastolic blood pressure > 100 mmHg or the use of medication for the treatment of hypertension
- Unstable medications (dosage must be stable for 90 days prior to randomization
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 |
|---|---|---|
| Isomaltooligosaccharide (digestion-resistant carbohydrates)Also: VitaSugar, VitaFiber12g/dose; three times a day | Other | VitaSugar/VitaFiber-IMO dose-1 |
| Isomaltooligosaccharide (digestion-resistant carbohydrates)Also: VitaSugar, VitaFiber18g/dose, three times a day | Other | VitaSugar/VitaFiber-IMO dose-2 |
| SucroseAlso: Table top sugar12g/dose, three times a day | Other | Placebo |
Primary outcome
Dose Tolerance
Time frame: one year
To Evalaute the dietary effects of two dosages of VitaSugar/VitaFiber-IMO on digestive health in healthy adults.
1 secondary outcome
Effect of IMO on human colon microflora and clinical chemistry
Time frame: One year
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 26 Jul 2012.
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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.
Mal Evans, PhD principal investigator
KGK Synergize
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Isomaltooligosaccharide (digestion-resistant carbohydrates) and Sucrose in people with Healthy, run by BioNeutra Inc. at 1 site in Canada.
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 0 inclusion and 13 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 26 Jul 2012. 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 Canada. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Dose Tolerance (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Jul 2012.