the Dietary Effects of VitaSugar/VitaFiber-IMO in Healthy Adults
NCT ID: NCT01462331
Last Updated: 2012-07-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
60 participants
INTERVENTIONAL
2010-11-30
2011-12-31
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TRIPLE
Study Groups
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VitaSugar/VitaFiber-IMO dose-1
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
Isomaltooligosaccharide (digestion-resistant carbohydrates)
12g/dose; three times a day
VitaSugar/VitaFiber-IMO dose-2
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
Isomaltooligosaccharide (digestion-resistant carbohydrates)
18g/dose, three times a day
Placebo
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
Sucrose
12g/dose, three times a day
Interventions
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Isomaltooligosaccharide (digestion-resistant carbohydrates)
12g/dose; three times a day
Isomaltooligosaccharide (digestion-resistant carbohydrates)
18g/dose, three times a day
Sucrose
12g/dose, three times a day
Other Intervention Names
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Eligibility Criteria
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Exclusion Criteria
2. Participation in a clinical research trial within 30 days prior to randomization
3. 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.
4. 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
5. Unstable medications (dosage must be stable for 90 days prior to randomization
6. Clinically significant abnormal laboratory results at screening
7. History of gastrointestinal disease (appendectomy is acceptable) or diabetes
8. Use of antibiotics and/or laxatives within 2 months prior to randomization
9. Use of food or supplements containing probiotics within 2 weeks prior to randomization and during the course of the study
10. Alcohol or drug abuse in past year
11. Allergy or sensitivity to test product ingredients
12. Individuals who are cognitively impaired and/or who are unable to give informed consent
13. 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.
18 Years
65 Years
ALL
Yes
Sponsors
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Alberta Agriculture and Rural Development
UNKNOWN
BioNeutra Inc.
OTHER
Responsible Party
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Principal Investigators
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Mal Evans, PhD
Role: PRINCIPAL_INVESTIGATOR
KGK Synergize
Locations
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KGK Synergize
London, Ontario, Canada
Countries
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Other Identifiers
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11VBHB
Identifier Type: -
Identifier Source: org_study_id