NCT01462331

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Nov 2010

Longer than P75 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2010

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

October 27, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 31, 2011

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

July 26, 2012

Status Verified

July 1, 2012

Enrollment Period

1 year

First QC Date

October 27, 2011

Last Update Submit

July 24, 2012

Conditions

Healthy

Keywords

IsomaltooligosaccharideHuman ConsumptionDose tolerancePrebioticShort chain fatty acidsBlood glucoseDose tolerance and prebiotic effect

Outcome Measures

Primary Outcomes (1)

  • Dose Tolerance

    To Evalaute the dietary effects of two dosages of VitaSugar/VitaFiber-IMO on digestive health in healthy adults.

    one year

Secondary Outcomes (1)

  • Effect of IMO on human colon microflora and clinical chemistry

    One year

Study Arms (3)

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

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

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

Other: Sucrose

Interventions

Isomaltooligosaccharide (digestion-resistant carbohydrates)OTHER

12g/dose; three times a day

Also known as: VitaSugar, VitaFiber
VitaSugar/VitaFiber-IMO dose-1
SucroseOTHER

12g/dose, three times a day

Also known as: Table top sugar
Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KGK Synergize

London, Ontario, N6A 5R8, Canada

Location

MeSH Terms

Interventions

Sucrose

Intervention Hierarchy (Ancestors)

DisaccharidesOligosaccharidesPolysaccharidesCarbohydratesSugars

Study Officials

  • Mal Evans, PhD

    KGK Synergize

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 27, 2011

First Posted

October 31, 2011

Study Start

November 1, 2010

Primary Completion

November 1, 2011

Study Completion

December 1, 2011

Last Updated

July 26, 2012

Record last verified: 2012-07

Locations

CA(1)