the Dietary Effects of VitaSugar/VitaFiber-IMO in Healthy Adults
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01462331|
Recruitment Status : Completed
First Posted : October 31, 2011
Last Update Posted : July 26, 2012
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Other: Isomaltooligosaccharide (digestion-resistant carbohydrates) Other: Sucrose||Phase 1|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Double-blind, Randomized, Placebo Controlled Study to Investigate the Dietary Effects of VitaSugar/VitaFiber-IMO in Healthy Adults|
|Study Start Date :||November 2010|
|Actual Primary Completion Date :||November 2011|
|Actual Study Completion Date :||December 2011|
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
Other: Isomaltooligosaccharide (digestion-resistant carbohydrates)
12g/dose; three times a day
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
Other: Isomaltooligosaccharide (digestion-resistant carbohydrates)
18g/dose, three times a day
Placebo Comparator: 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
12g/dose, three times a day
Other Name: Table top sugar
- Dose Tolerance [ Time Frame: one year ]To Evalaute the dietary effects of two dosages of VitaSugar/VitaFiber-IMO on digestive health in healthy adults.
- Effect of IMO on human colon microflora and clinical chemistry [ Time Frame: One year ]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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years to 65 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- 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).
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
- 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
- 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.
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): NCT01462331
|London, Ontario, Canada, N6A 5R8|
|Principal Investigator:||Mal Evans, PhD||KGK Synergize|
|Responsible Party:||BioNeutra Inc.|
|Other Study ID Numbers:||
|First Posted:||October 31, 2011 Key Record Dates|
|Last Update Posted:||July 26, 2012|
|Last Verified:||July 2012|
Short chain fatty acids
Dose tolerance and prebiotic effect