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

Publisher: BMJ Publishing Group Ltd Country of Publication: England NLM ID: 101552874 Publication Model: Electronic Cited Medium: Internet ISSN: 2044-6055 (Electronic) Linking ISSN: 20446055 NLM ISO Abbreviation: BMJ Open Subsets: MEDLINE

Original Publication: [London] : BMJ Publishing Group Ltd, 2011-

Diabetes Mellitus, Type 2*/therapy ; Lacticaseibacillus rhamnosus*/metabolism ; Prediabetic State*/therapy ; Probiotics*/therapeutic use; Adult ; Australia ; Blood Glucose/metabolism ; Capsules ; Double-Blind Method ; Glycated Hemoglobin/metabolism ; Humans ; Outcome Assessment, Health Care ; Prebiotics

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 (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.
Competing Interests: Competing interests: None declared.
(© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Int J Obes (Lond). 2013 Dec;37(12):1597-602. (PMID: 23588625)
Clin Orthop Surg. 2014 Mar;6(1):103-9. (PMID: 24605197)
Lancet. 2006 Nov 11;368(9548):1673-9. (PMID: 17098085)
Anaerobe. 2014 Feb;25:11-7. (PMID: 24239979)
Diabetologia. 2013 Feb;56(2):284-93. (PMID: 23093136)
Diabetes Res Clin Pract. 2016 Aug;118:172-82. (PMID: 27388674)
Endocr Rev. 2019 Aug 1;40(4):988-999. (PMID: 31074800)
Mol Nutr Food Res. 2019 Apr;63(7):e1800870. (PMID: 30636111)
Crit Rev Food Sci Nutr. 2021;61(10):1670-1688. (PMID: 32436397)
Lancet. 2012 Jun 16;379(9833):2279-90. (PMID: 22683128)
Diabetologia. 1985 Jul;28(7):412-9. (PMID: 3899825)
Br J Nutr. 2016 Apr 14;115(7):1167-77. (PMID: 26899960)
Br J Clin Psychol. 2005 Jun;44(Pt 2):227-39. (PMID: 16004657)
J Affect Disord. 2012 Oct;142 Suppl:S8-21. (PMID: 23062861)
Nutrients. 2021 Jan 13;13(1):. (PMID: 33450885)
Trials. 2019 Jul 29;20(1):464. (PMID: 31358022)
Lancet Diabetes Endocrinol. 2014 Jun;2(6):474-80. (PMID: 24731674)
Trends Neurosci. 2013 May;36(5):305-12. (PMID: 23384445)
Int J Syst Evol Microbiol. 2020 Apr;70(4):2782-2858. (PMID: 32293557)
Nutrients. 2019 Nov 01;11(11):. (PMID: 31683759)
Eur J Clin Nutr. 2013 Apr;67(4):310-7. (PMID: 23422921)
Am J Clin Nutr. 2014 Dec;100(6):1413-21. (PMID: 25411276)
Lancet. 2009 Nov 14;374(9702):1677-86. (PMID: 19878986)
Nutr Healthy Aging. 2018 Jun 15;4(4):267-285. (PMID: 29951588)
Diabetologia. 2021 Jan;64(1):26-41. (PMID: 33047170)
Front Psychol. 2021 May 04;12:637547. (PMID: 34017283)
Foods. 2020 Oct 26;9(11):. (PMID: 33114518)
Sci Rep. 2020 Sep 8;10(1):14790. (PMID: 32901098)
Diabetol Metab Syndr. 2020 Nov 11;12(1):98. (PMID: 33292434)
Diabetes Care. 2019 Jun;42(6):1009-1017. (PMID: 30967436)
EBioMedicine. 2017 Oct;24:159-165. (PMID: 28943228)
Nat Rev Gastroenterol Hepatol. 2019 Oct;16(10):605-616. (PMID: 31296969)
Nutrients. 2020 Nov 17;12(11):. (PMID: 33212907)
Food Funct. 2019 Mar 20;10(3):1747-1759. (PMID: 30860222)
Diabetes Care. 2003 Dec;26(12):3230-6. (PMID: 14633807)
Diabetes Care. 1997 Apr;20(4):537-44. (PMID: 9096977)
Clin Nutr. 2018 Apr;37(2):532-541. (PMID: 28318686)
Psychol Assess. 2013 Dec;25(4):1103-10. (PMID: 23730826)
Br J Nutr. 2017 Mar;117(6):804-813. (PMID: 28367765)
Aust N Z J Public Health. 1999 Aug;23(4):401-6. (PMID: 10462864)
N Engl J Med. 2002 Feb 7;346(6):393-403. (PMID: 11832527)
World J Gastroenterol. 2014 Nov 21;20(43):16079-94. (PMID: 25473159)
Hypertension. 2014 Oct;64(4):897-903. (PMID: 25047574)
Aust N Z J Public Health. 2013 Feb;37(1):24-31. (PMID: 23379802)
Prev Nutr Food Sci. 2020 Jun 30;25(2):113-123. (PMID: 32676461)
Lancet. 2008 May 24;371(9626):1783-9. (PMID: 18502303)

Keywords: diabetes & endocrinology; general diabetes; preventive medicine

0 (Blood Glucose)
0 (Capsules)
0 (Glycated Hemoglobin A)
0 (Prebiotics)

Date Created: 20220325 Date Completed: 20220414 Latest Revision: 20221207

20231215

PMC8948404

10.1136/bmjopen-2021-055214

35332040