Konjac-Glucomannan Fibre Blend and American Ginseng in Type 2 Diabetes

June 15, 2016 updated by: Vladimir Vuksan

Effect of Co-administration of a Konjac-Glucomannan Fibre Blend and American Ginseng (Panax Quinquefolius L.) on Glycemia and Serum Lipids in Well-controlled Type 2 Diabetes: A Randomized Controlled, Clinical Trial

The purpose of this study was to determine whether the co-administration of a konjac-glucomannan fibre blend and American ginseng in a randomized, placebo-controlled, cross-over trial can improve diabetes management.

Study Overview

Detailed Description

The study used a partially blinded, randomized, placebo controlled, crossover design. Due to the nature of the fibres it was not possible to blind the participant with respect to type of fibre. The study was divided into two phases with each phase having a four 4-week run-in period, and a 12-week treatment period, separated by a minimum 4-week wash-out period.

The treatments consisted of an ad libitum Canadian Diabetes Association recommended diet supplemented with capsules which contained either cornstarch (control) or AG (test) and a fiber supplement consisting of either wheat bran (control) or a viscous fiber blend of konjac mannan and xanthan (test). Participants were asked to attend the clinic at weeks -4, 0, 3, 6, and 12 during each phase.

Outcome measures There were three levels of outcome measures including efficacy, safety, and compliance. Statistical analysis The results are presented as mean ± SEM and considered statistically significant at p<0.05. Statistical analysis was performed using the SAS version 8.2 (SAS Institute, Cary, NC). Parametric analyses were conducted following a comparison of the sampling distribution to a normal distribution (Shapiro-Wilk and Kolmogorov-Smirnov tests). GLM was used to perform two-way ANOVA to detect differences of outcome variables in treatments and visits, controlling for treatment sequence and sex. If the effect of treatment was significant then percent differences were calculated between weeks 12 of test and control and analyzed using the GLM repeated measures one-way ANOVA controlling for sex. Parametric analyses were conducted following a comparison of the sampling distribution to a normal distribution (Shapiro-Wilk and Kolmogorov-Smirnov tests). The tests did not reject the null hypothesis at α=0.05. All comparisons were paired, thus each participant served as his/her own control. As this was a cross-over study, only participants who completed the study were included in the analysis.

Study Type

Interventional

Enrollment (Actual)

39

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Ontario
      • Toronto, Ontario, Canada, M5C 2T2
        • Clinical Risk Factor and Modification Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of type 2 diabetes of at least 1 year
  • age between 40 and 75 years old
  • treated with diet and anti hyperglycemic medications
  • HbA1c between 6.5% and 8.4%
  • Systolic blood pressure <140mmHg
  • Diastolic blood pressure <90mmHg
  • Clinically euthyroid
  • Normal renal and liver function

Exclusion Criteria:

  • treated with insulin
  • age less than 40 or older than 75 years old at the start of the trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control
3g/d Cornstarch and 14g/d wheat bran control
Fiber matched control for intervention (corn starch and wheat bran)
Experimental: K-GB&AG
3g/d American Ginseng and 7g/d Konjac-glucomannan fiber blend
herb
Other Names:
  • Panax quinquefolius L.
Blend of 2 viscous fibers: konjac mannan and xanthan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HbA1c
Time Frame: Week 12
Difference at week 12 between control and test intervention
Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Cholesterol
Time Frame: Week 12
Difference at week 12 between control and test intervention
Week 12
High sensitivity C reactive protein
Time Frame: Week 12
Difference at week 12 between control and test intervention
Week 12
Apolipoprotein A and B
Time Frame: Week 12
Difference at week 12 between control and test intervention
Week 12
Oxidized LDL
Time Frame: Week 12
Difference at week 12 between control and test intervention
Week 12
Blood pressure
Time Frame: Week 12
Difference at week 12 between control and test intervention
Week 12
LDL Cholesterol
Time Frame: week 12
Difference at week 12 between control and test intervention
week 12
Triglycerides
Time Frame: week 12
Difference at week 12 between control and test intervention
week 12
HDL-cholesterol
Time Frame: week 12
Difference at week 12 between control and test intervention
week 12
fasting glucose
Time Frame: week 12
Difference at week 12 between control and test intervention
week 12
fasting insulin
Time Frame: week 12
Difference at week 12 between control and test intervention
week 12

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
AST
Time Frame: Week 12
Difference at week 12 between control and test intervention
Week 12
creatinine
Time Frame: Week 12
Difference at week 12 between control and test intervention
Week 12
Clotting factors
Time Frame: Week 12
Difference at week 12 between control and test intervention
Week 12
Subjective symptoms
Time Frame: week 12
VAS scale, Difference at week 12 between control and test intervention
week 12
Dietary change
Time Frame: week 12
3 day dietary record, difference at week 12 between control and test intervention
week 12
ALT
Time Frame: week 12
Difference at week 12 between control and test intervention
week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2002

Primary Completion (Actual)

November 1, 2004

Study Completion (Actual)

March 1, 2005

Study Registration Dates

First Submitted

March 2, 2016

First Submitted That Met QC Criteria

June 15, 2016

First Posted (Estimate)

June 20, 2016

Study Record Updates

Last Update Posted (Estimate)

June 20, 2016

Last Update Submitted That Met QC Criteria

June 15, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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