medwireNews: A randomised trial shows that use of a prebiotic fibre-enriched nutritional formula results in improved life quality and, potentially, better glycaemic control in people with type 2 diabetes.
The intervention therefore “may serve as a complement to lifestyle and/or pharmaceutical interventions for improving quality of life in people with [type 2 diabetes]”, write the researchers in Diabetes, Obesity and Metabolism.
However, they stress that further studies powered for metabolic endpoints are needed.
The active intervention consisted of an iso-caloric, iso-protein nutritional formula enriched for resistant starch and oat beta glucan. Over the course of 12 weeks, study participants randomly assigned to take the enriched formula took up to two doses per day, with at least one replacing a meal.
These 95 people had a significant improvement in the primary endpoint of core Type 2 Diabetes Distress Assessment System (cT2-DDAS) score, from an average of 3.1 to 2.8, and the researchers stress that this group had improvements in seven of the eight questions contributing to the total score.
An additional 48 participants who were randomly assigned to take a non-enriched, placebo version of the formula (ie, without the fibre) had a slight deterioration in cT2-DDAS score, from an average of 3.0 to 3.1, and a further 49 people who received dietary advice only had no change in their average score.
Christopher Damman (University of Washington, Seattle, USA) and co-researchers say that identifying the mechanisms underlying the improved life quality in the active formula group “were beyond the scope of the present trial”, but suggest that a contributing factor may have been the participants’ “optimism around improved metabolic health metrics.”
Indeed, the average glycated haemoglobin (HbA1c) levels fell by 0.36% in the enriched formula group, which was a significant improvement relative to the 0.30% increase seen with the placebo formula and the 0.17% reduction in the control group, which the researchers attribute “to improvement in postprandial glucose, as no change was seen in plasma fasting glucose.”
However, the team notes that previous research has provided evidence for a direct effect of the microbiome on several neurocognitive outcomes.
Participants of the current study were an average age of 54.3 years and the majority (62.5%) were White, but 19.3% were Black and 14.6% Hispanic/Latino. Their average diabetes duration was 8.6 years, average HbA1c was 7.8% and BMI was 35.9 kg/m2.
Of note, people taking either formula reported an improvement of approximately 2 points on the Gastrointestinal Symptom Rating Scale, whereas those in dietary advice group had an average 3.6 point deterioration.
“This may be explained in part by regulation of incretin hormones and their impact on nausea”, suggest Damman et al.
“Indeed it is intriguing to hypothesize that fermentable fibers such as the type 2 resistant starch and oat beta-glucan used in this study could be a complement to dual-agonist therapy in helping mitigate upper [gastrointestinal] side effects.”
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Diabetes Obes Metab 2023; doi:10.1111/dom.14967