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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Dietary Supplement: American Ginseng
* Dietary Supplement: Konjac-glucomannan fiber blend
* Dietary Supplement: Control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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American ginseng, Konjac glucomannan fiber