In:
BMJ Open, BMJ, Vol. 12, No. 3 ( 2022-03), p. e055214-
Abstract:
To evaluate the effect of the probiotic Lactobacillus rhamnosus 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 1c ) 41–49 mmol/mol. Interventions Capsules containing Lactobacillus rhamnosus (HN001) (6×10 9 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 1c 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 1c outcome data available for 129 participants. At 6 months the mean (SD) HbA 1c was 45.9 (4.4) mmol/mol, n = 66 for HN001, and 46.7 (4.3) mmol/mol, n = 63 for placebo capsules; 46.5 (4.0) mmol/mol, n = 67 for OBG and 46.0 (4.6) mmol/mol n = 62 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 1c and all secondary outcomes relevant to adults with pre-diabetes. Trial registration number Australian New Zealand Clincial Trials Registry number ACTRN12617000990325
Type of Medium:
Online Resource
ISSN:
2044-6055
,
2044-6055
DOI:
10.1136/bmjopen-2021-055214
DOI:
10.1136/bmjopen-2021-055214.supp1
Language:
English
Publisher:
BMJ
Publication Date:
2022
detail.hit.zdb_id:
2599832-8
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