- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02806349
Konjac-Glucomannan Fibre Blend and American Ginseng in Type 2 Diabetes
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
Study Overview
Status
Conditions
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
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5C 2T2
- Clinical Risk Factor and Modification Centre
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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:
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
Sponsor
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RB02-014C
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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.
Clinical Trials on Diabetes Mellitus, Type 2
-
SanofiCompletedType 1 Diabetes Mellitus-Type 2 Diabetes MellitusHungary, Russian Federation, Germany, Poland, Japan, United States, Finland
-
Scripps Whittier Diabetes InstituteSan Diego State UniversityCompletedType 2 Diabetes Mellitus (T2DM)United States
-
Griffin HospitalCalifornia Walnut CommissionCompletedDIABETES MELLITUS TYPE 2United States
-
Mannkind CorporationTerminatedType 2 Diabetes Mellitus | Type 1 Diabetes MellitusUnited States
-
US Department of Veterans AffairsAmerican Diabetes AssociationCompletedType 2 Diabetes MellitusUnited States
-
Dexa Medica GroupCompletedType-2 Diabetes MellitusIndonesia
-
Daewoong Pharmaceutical Co. LTD.Not yet recruitingT2DM (Type 2 Diabetes Mellitus)
-
Zhongda HospitalRecruitingType 2 Diabetes Mellitus (T2DM)China
-
Shanghai Golden Leaf MedTec Co. LtdRecruitingType 2 Diabetes Mellitus (T2DM)China
-
Newsoara Biopharma Co., Ltd.RecruitingT2DM (Type 2 Diabetes Mellitus)China
Clinical Trials on Control
-
Claudia M. WittCompleted
-
University of California, San FranciscoWithdrawn
-
Universidad Nacional de Educación a DistanciaMinisterio de Economía y Competitividad, SpainUnknownChronic Pain | FibromyalgiaSpain
-
University of California, Los AngelesThe National Council on Aging; City of Los Angeles Department of Aging; Los Angeles...Completed
-
Queen's University, BelfastPublic Health Agency, Health and Social Care Research and Development; Tiny...Completed
-
National Taiwan University HospitalEnrolling by invitationCognitive Function | Atrial Fibrillation, PersistentTaiwan
-
Takeshi MorimotoUniversity of the RyukyusActive, not recruitingCoronary Artery Disease | Hypertension | Type 2 Diabetes | DyslipidemiaJapan
-
Johnson & Johnson Vision Care, Inc.TerminatedRefractive Error CorrectionUnited States
-
Vanderbilt University Medical CenterCompleted
-
University Hospital, LilleCompleted