Konjac-Glucomannan Fibre Blend and American Ginseng in Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

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.
    

Intervention name(s): American Ginseng; Konjac-glucomannan fiber blend; Control
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): herb; Blend of 2 viscous fibers: konjac mannan and xanthan; Fiber matched control for intervention (corn starch and wheat bran)
Other intervention name(s): Panax quinquefolius L.
Intervention MeSH terms: (1-6)-alpha-glucomannan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: American ginseng; Konjac glucomannan fiber