Abstract
Purpose
Soluble fibre beneficially affects metabolism but whether it can augment the reductions in glycemia induced through intensive weight management has not been extensively studied. Our objective was to examine the adjunct effect of the soluble viscous fibre PGX® on glycemic control in adults with type 2 diabetes (T2D) enrolled in a year-long medically supervised weight management program.
Methods
In a placebo-controlled, double-blind study, 290 adults with overweight/obesity and T2D were randomized to receive PGX (15–20 g/day) or isocaloric placebo (rice flour, 6.4–8.6 g/day) as an adjunct to intensive weight management for 52 weeks. The primary outcome was change in glycemic control (HbA1c). Other outcome measures included weight loss, blood lipids, blood pressure, cytokines and fecal microbiota.
Results
Compared to baseline HbA1c in PGX (7.2 ± 1.1%) and placebo (7.0 ± 0.9%) groups, there was a significant reduction at 16 and 26 weeks, however, only PGX showed a significant absolute reduction of 0.23% at 52 weeks; there were no between-group differences in HbA1c. At 52 weeks, only PGX significantly decreased body weight compared to baseline and reduced waist circumference at all time points. Compared to baseline, only PGX showed a significant reduction in LDL cholesterol at 16 and 26 weeks. PGX significantly increased the relative abundance of Collinsella, Parabacteroides and Roseburia.
Conclusion
Adding PGX to a weight management program for individuals with T2D provides a sustained reduction in HbA1c compared to placebo. Improvements in other metabolic outcomes suggest that PGX may be a promising adjunct to weight loss programs in patients with T2D.
Clinical trial
This trial was registered at ClinicalTrials.gov as NCT01644201.
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Acknowledgements
This study was sponsored by InovoBiologic Inc., Calgary, Canada. RAR, SWharton, TG, PM, MRL, RJG and SWood designed the research. SWharton conducted the study. HRR performed microbiota bioinformatics. RAR analyzed data, wrote the paper and had primary responsibility for final content. All authors critically read and approved the final manuscript.
Funding
This study was sponsored by InovoBiologic Inc., Calgary, Canada.
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Conflict of interest
RAR and S Wood receive consulting fees from InovoBiologic Inc. RAR received financial support for the preparation of this manuscript. S Wharton received funds to pay clinical staff for the conduct of the study. S Wood has an InovoBiologic Inc. patent pending. MRL receives consulting fees from the Factors Group of Companies and holds various patents on PGX®. RJG is the owner of the Factors Group of Companies and holds various patents on PGX. TG, PM and HRR declare no conflict of interest.
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Reimer, R.A., Wharton, S., Green, T.J. et al. Effect of a functional fibre supplement on glycemic control when added to a year-long medically supervised weight management program in adults with type 2 diabetes. Eur J Nutr 60, 1237–1251 (2021). https://doi.org/10.1007/s00394-020-02328-8
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DOI: https://doi.org/10.1007/s00394-020-02328-8