A microbiome‐targeting fibre‐enriched nutritional formula is well tolerated and improves quality of life and haemoglobin A1c in type 2 diabetes: A double‐blind , randomized, placebo‐controlled trial
Primary result · Change in cT2-DDASResult — go to the resultDifference −0.4Authors' conclusion
A microbiome-targeting nutritional formula significantly improved cT2-DDAS and HbA1c, suggesting the potential for prebiotic fibre as a complement to lifestyle and/or pharmaceutical interventions for managing type 2 diabetes.
Study context
- Population
- Adults with T2D; mean age 54.3 years, HbA1c 7.8%, BMI 35.9 kg/m²randomized
- Participants
- 192 adults
- Comparison
- Prebiotic fibre-enriched nutritional formula vs placebo fibre-absent formula vs dietary advice alone
- Primary endpoint
- Change in core Type 2 Diabetes Distress Assessment System (cT2-DDAS)
- Follow-up
- Week 12
Methodological detailsdouble-blind, placebo-controlled, unblinded dietary advice only comparator arm, randomized 2:1:1
- Double-blind
- Placebo-controlled
- Unblinded dietary advice only comparator arm
- Randomized 2:1:1
Primary result
Change in cT2-DDAS
Difference
−0.4
P = 0.03
As reported in the abstract
Secondary outcomes
| Outcome | Difference (%) | P value |
|---|---|---|
| HbA1c change (key secondary endpoint) · week 12Active vs Placebo · reduced significantly in Active vs Placebo | −0.64 | P = 0.01 |
Gut microbiome: relative abundance of butyrate-producing bacteria
- Relative abundance of Roseburia faecis and Anaerostipes hadrus increased significantly in Active vs Placebo
Original publication
A microbiome‐targeting fibre‐enriched nutritional formula is well tolerated and improves quality of life and haemoglobin A1c in type 2 diabetes: A double‐blind , randomized, placebo‐controlled trial. Diabetes Obes Metab. Published 23 January 2023. doi:10.
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