Gastrointestinal Tolerability and Acute Glycemic Response of Oligosaccharides and Polysaccharides from Cellulose and Xylan in Healthy Adults: Two Double-Blinded, Randomized, Controlled, Cross-over Trials

Abstract

Objective

The aim of this study was to investigate the gastrointestinal tolerability, glycemic and insulinemic responses of Plant Fiber Extract (PFE), a mixture comprising of oligosaccharides and polysaccharides derived from cellulose and xylan.

Methods

Two double-blind, randomized, controlled, cross-over trials were conducted in healthy adults. In the first trial, participants (n = 29) consumed either 25, 35 or 45 g per day of PFE or resistant maltodextrin (Control) for 14 days. The occurrence and severity of gastrointestinal (GI) symptoms, stool parameters, and safety outcomes were evaluated with a combination of surveys and blood analysis respectively. In the second trial (n = 20), the post-prandial glycemic and insulinemic responses after the ingestion of 20 g of PFE diluted in water or incorporated into chocolate chips was measured and then compared to that of glucose and regular chocolate, respectively.

Results

For all timepoints (0, 7 and 14 days), within any given dose group, there was no statistically significant difference in the GI symptoms score between PFE and Control. Further, for each test product (PFE or Control), no difference was observed in the same dose group from days 0 and 14. Stool consistency score and number of participants experiencing loose or watery stools was similar between products. No serious adverse events were reported and neither PFE nor Control significantly altered blood or urine safety parameters. The glycemic and insulinemic responses after PFE ingestion in comparison to glucose were 12% and 8% respectively. The glycemic and insulinemic responses after consuming chocolate containing PFE were 20% of that of regular chocolate.

Conclusion

PFE was well-tolerated by healthy volunteers in doses up to 45 g/day and it elicited comparatively low glycemic and insulinemic responses when consumed alone or when incorporated into a food product.

Keywords:

• Oligosaccharides
• xylan
• cellulose
• tolerability
• glycemic response

Acknowledgments

The authors thank Gillian Dunn Galvin, Emily Goodbody, Thomas Wolever, and all personnel from Atlantia Food Clinical Trials and INQUIS Clinical Research who were involved in the studies for their contributions on data collection and analysis. Authors also thank the participants of the studies.

Authors’ contributions

Beltrame: data analysis and interpretation, manuscript writing. Simmons: manuscript review and editing. Dinan and Jenkins: study design, coordination of data acquisition and analysis for Studies 1 and 2, respectively. Nicholson: study design conception, project administration and manuscript writing. All authors revised and approved the final manuscript.

Disclosure statement

Beltrame, Nicholson and Simmons are employed by Cambridge Glycoscience Ltd.

Clinical trial registry number

Study 1: NCT05051202.

Study 2: NCT05587426.

Data availability statement

The data presented here may be available upon reasonable request from the corresponding author and in accordance with intellectual property considerations.

Additional information

Funding

This work was funded by Cambridge Glycoscience Ltd (Cambridge, UK).