the Dietary Effects of VitaSugar/VitaFiber-IMO in Healthy Adults

Phase 1

Completed

• Conditions: Healthy
• Interventions: Other: Isomaltooligosaccharide (digestion-resistant carbohydrates); Other: Sucrose

• Registration Number: NCT01462331
• Lead Sponsor: BioNeutra Inc.

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 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 Timeline

• Study Start: 2010-11
• Study First Submitted: 2011-10-27
• Study First Submitted QC: 2011-10-28
• Study First Posted: 2011-10-31
• Primary Completion: 2011-11
• Study Completion: 2011-12
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-24
• Last Update Posted: 2012-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

1. Women who are pregnant, breastfeeding, or planning to become pregnant during the course of the trial
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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VitaSugar/VitaFiber-IMO dose-1	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	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	Sucrose	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

Primary Outcome Measures

Name	Time	Method
Dose Tolerance	one year	To Evalaute the dietary effects of two dosages of VitaSugar/VitaFiber-IMO on digestive health in healthy adults.

Secondary Outcome Measures

Name	Time	Method
Effect of IMO on human colon microflora and clinical chemistry	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.

Trial Locations

Locations (1)

KGK Synergize; 🇨🇦 London, Ontario, Canada