Diabetes Mellitus, Type 2
Conditions
Keywords
American ginseng, Konjac glucomannan fiber
Brief summary
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
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.
Interventions
DIETARY_SUPPLEMENTAmerican Ginseng
herb
DIETARY_SUPPLEMENTKonjac-glucomannan fiber blend
Blend of 2 viscous fibers: konjac mannan and xanthan
DIETARY_SUPPLEMENTControl
Fiber matched control for intervention (corn starch and wheat bran)
Sponsors
Canadian Diabetes Association
Vladimir Vuksan
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HbA1c | Week 12 | Difference at week 12 between control and test intervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Apolipoprotein A and B | Week 12 | Difference at week 12 between control and test intervention |
| Blood pressure | Week 12 | Difference at week 12 between control and test intervention |
| LDL Cholesterol | week 12 | Difference at week 12 between control and test intervention |
| Triglycerides | week 12 | Difference at week 12 between control and test intervention |
| HDL-cholesterol | week 12 | Difference at week 12 between control and test intervention |
| fasting glucose | week 12 | Difference at week 12 between control and test intervention |
| fasting insulin | week 12 | Difference at week 12 between control and test intervention |
| Total Cholesterol | Week 12 | Difference at week 12 between control and test intervention |
| High sensitivity C reactive protein | Week 12 | Difference at week 12 between control and test intervention |
| Oxidized LDL | Week 12 | Difference at week 12 between control and test intervention |
Other
| Measure | Time frame | Description |
|---|---|---|
| Clotting factors | Week 12 | Difference at week 12 between control and test intervention |
| Subjective symptoms | week 12 | VAS scale, Difference at week 12 between control and test intervention |
| Dietary change | week 12 | 3 day dietary record, difference at week 12 between control and test intervention |
| ALT | week 12 | Difference at week 12 between control and test intervention |
| AST | Week 12 | Difference at week 12 between control and test intervention |
| creatinine | Week 12 | Difference at week 12 between control and test intervention |
Countries
Canada
Outcome results
None listed