A randomised controlled trial of a probiotic and a prebiotic examining metabolic and mental health outcomes in adults with pre-diabetes.

AIMS

To evaluate the effect of the probiotic HN001 and/or cereal enriched with oat-derived beta-glucan (OBG) on metabolic and mental health outcomes when administered to adults with pre-diabetes.

DESIGN

2×2 factorial design randomised, parallel-groups placebo-controlled; double-blinded for probiotic, single-blinded for cereals.

PARTICIPANTS

Community-dwelling adults aged 18-80 years with pre-diabetes: glycated haemoglobin (HbA) 41-49 mmol/mol.

INTERVENTIONS

Capsules containing (HN001) (6×10 colony-forming units/day), or placebo capsules; and cereal containing 4 g/day OBG or calorie-matched control cereal, taken daily, for 6 months. Study groups were: (A) HN001 capsules+OBG cereal; (B) HN001 capsules+control cereal; (C) placebo capsules+OBG cereal and (D) placebo capsules+control cereal.

OUTCOME MEASURES

Primary outcome: HbA at 6 months.

SECONDARY OUTCOMES

fasting plasma glucose, fasting insulin, homeostatic model assessment of insulin resistance, fasting lipids, blood pressure, body weight, waist circumference, body mass index and mental well-being.

RESULTS

153 participants were randomised. There was complete HbA outcome data available for 129 participants. At 6 months the mean (SD) HbA was 45.9 (4.4) mmol/mol, n66 for HN001, and 46.7 (4.3) mmol/mol, n63 for placebo capsules; 46.5 (4.0) mmol/mol, n67 for OBG and 46.0 (4.6) mmol/mol n62 for control cereal. The estimated difference between HN001-placebo capsules was -0.83, 95% CI -1.93 to 0.27 mmol/mol, p=0.63, and between OBG-control cereals -0.17, 95% CI -1.28 to 0.94 mmol/mol, p=0.76. There was no significant interaction between treatments p=0.79. There were no differences between groups or significant interactions between treatments for any of the secondary outcomes.

CONCLUSIONS

This study found no evidence of clinical benefit from the supplementation with either HN001 and/or cereal containing 4 g OBG on HbA and all secondary outcomes relevant to adults with pre-diabetes.

TRIAL REGISTRATION NUMBER

Australian New Zealand Clincial Trials Registry number ACTRN12617000990325.