Status:
COMPLETED
the Dietary Effects of VitaSugar/VitaFiber-IMO in Healthy Adults
Lead Sponsor:
BioNeutra Inc.
Collaborating Sponsors:
Alberta Agriculture and Rural Development
Conditions:
Healthy
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief 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.
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 ...
Eligibility Criteria
Inclusion
- Male or female aged 18 to 65 years
- If female, subject is not of child bearing potential. Defined as females who have had a hysterectomy or oophorectomy, bilateral tubal ligation or are post-menopausal (natural or surgically with \> 1 year since last menstruation).
- OR
- Female subject of childbearing potential must agree to use a medically approved method of birth control and have a negative urine pregnancy test result. Acceptable methods of birth control include:
- Double-barrier method (condoms with spermicide or diaphragm with spermicide)
- Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System)
- Intrauterine devices
- Vasectomy of partner
- Abstinence
- Healthy as determined by laboratory results, medical history
- Agrees not to change current dietary habits and activity levels during the course of the study
- Has given voluntary, written, informed consent to participate in the study
- Exclusion Criteria:
- 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
- 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.
Exclusion
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01462331
Start Date
November 1 2010
End Date
December 1 2011
Last Update
July 26 2012
Active Locations (1)
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1
KGK Synergize
London, Ontario, Canada, N6A 5R8