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

Phase 2

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Dietary Supplement: Control; Dietary Supplement: American Ginseng; Dietary Supplement: Konjac-glucomannan fiber blend

• Registration Number: NCT02806349
• Lead Sponsor: Vladimir Vuksan

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.

Study Timeline

• Study Start: 2002-03
• Primary Completion: 2004-11
• Study Completion: 2005-03
• Study First Submitted: 2016-03-02
• Status Verified: 2016-06
• Study First Submitted QC: 2016-06-15
• Last Update Submitted: 2016-06-15
• Study First Posted: 2016-06-20
• Last Update Posted: 2016-06-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
K-GB&AG	Konjac-glucomannan fiber blend	3g/d American Ginseng and 7g/d Konjac-glucomannan fiber blend
Control	Control	3g/d Cornstarch and 14g/d wheat bran control
K-GB&AG	American Ginseng	3g/d American Ginseng and 7g/d Konjac-glucomannan fiber blend

Primary Outcome Measures

Name	Time	Method
HbA1c	Week 12	Difference at week 12 between control and test intervention

Secondary Outcome Measures

Name	Time	Method
High sensitivity C reactive protein	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
Oxidized LDL	Week 12	Difference at week 12 between control and test intervention
Total Cholesterol	Week 12	Difference at week 12 between control and test intervention
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
Triglycerides	week 12	Difference at week 12 between control and test intervention
fasting insulin	week 12	Difference at week 12 between control and test intervention
LDL Cholesterol	week 12	Difference at week 12 between control and test intervention

Trial Locations

Locations (1)

Clinical Risk Factor and Modification Centre; 🇨🇦 Toronto, Ontario, Canada