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 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; doubl...
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BMJ Publishing Group
2022-03-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/12/3/e055214.full |
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| author | Mark Weatherall Julian Crane Jeremy Krebs Mark Huthwaite Christine Barthow Fiona Hood Amber Parry-Strong |
| author_facet | Mark Weatherall Julian Crane Jeremy Krebs Mark Huthwaite Christine Barthow Fiona Hood Amber Parry-Strong |
| author_sort | Mark Weatherall |
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| description | Aims 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 (HbA1c) 41–49 mmol/mol.Interventions Capsules containing Lactobacillus rhamnosus (HN001) (6×109 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: HbA1c 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 HbA1c outcome data available for 129 participants. At 6 months the mean (SD) HbA1c 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 HbA1c and all secondary outcomes relevant to adults with pre-diabetes.Trial registration number Australian New Zealand Clincial Trials Registry number ACTRN12617000990325 |
| format | Article |
| id | doaj-art-1b29256434b64f4b87cc09c8e485e49e |
| institution | OA Journals |
| issn | 2044-6055 |
| language | English |
| publishDate | 2022-03-01 |
| publisher | BMJ Publishing Group |
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| series | BMJ Open |
| spelling | doaj-art-1b29256434b64f4b87cc09c8e485e49e2025-08-20T02:17:35ZengBMJ Publishing GroupBMJ Open2044-60552022-03-0112310.1136/bmjopen-2021-055214A randomised controlled trial of a probiotic and a prebiotic examining metabolic and mental health outcomes in adults with pre-diabetesMark Weatherall0Julian Crane1Jeremy Krebs2Mark Huthwaite3Christine Barthow4Fiona Hood5Amber Parry-Strong6Victoria University, Wellington, New ZealandDepartment of Medicine, Univeristy of Otago, Wellington, New ZealandDepartment of Medicine, Univeristy of Otago, Wellington, New ZealandDepartment of Psychological Medicine, University of Otago, Wellington, New ZealandDepartment of Medicine, Univeristy of Otago, Wellington, New ZealandDepartment of Medicine, University of Otago, Dunedin, New ZealandCentre for Endocrine, Diabetes and Obesity Research, Capital and Coast District Health Board, Wellington, New ZealandAims 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 (HbA1c) 41–49 mmol/mol.Interventions Capsules containing Lactobacillus rhamnosus (HN001) (6×109 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: HbA1c 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 HbA1c outcome data available for 129 participants. At 6 months the mean (SD) HbA1c 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 HbA1c and all secondary outcomes relevant to adults with pre-diabetes.Trial registration number Australian New Zealand Clincial Trials Registry number ACTRN12617000990325https://bmjopen.bmj.com/content/12/3/e055214.full |
| spellingShingle | Mark Weatherall Julian Crane Jeremy Krebs Mark Huthwaite Christine Barthow Fiona Hood Amber Parry-Strong A randomised controlled trial of a probiotic and a prebiotic examining metabolic and mental health outcomes in adults with pre-diabetes BMJ Open |
| title | A randomised controlled trial of a probiotic and a prebiotic examining metabolic and mental health outcomes in adults with pre-diabetes |
| title_full | A randomised controlled trial of a probiotic and a prebiotic examining metabolic and mental health outcomes in adults with pre-diabetes |
| title_fullStr | A randomised controlled trial of a probiotic and a prebiotic examining metabolic and mental health outcomes in adults with pre-diabetes |
| title_full_unstemmed | A randomised controlled trial of a probiotic and a prebiotic examining metabolic and mental health outcomes in adults with pre-diabetes |
| title_short | A randomised controlled trial of a probiotic and a prebiotic examining metabolic and mental health outcomes in adults with pre-diabetes |
| title_sort | randomised controlled trial of a probiotic and a prebiotic examining metabolic and mental health outcomes in adults with pre diabetes |
| url | https://bmjopen.bmj.com/content/12/3/e055214.full |
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