None listed
Conditions
Brief summary
A quarter of New Zealanders have pre-diabetes which is a condition that can progress to type 2 diabetes and cause significant long term health problems including cardiovascular disease, There is now exciting research demonstrating that microbes in our gut affect our health in many ways, including how our bodies process foods and sugars. We can modify our gut microbes by taking supplements of probiotics (which contain live bacteria that give health benefits) and cereals (which contain substances that support the growth of gut microbes). This study is a blinded randomised placebo-controlled trial with four groups. Adults with pre-diabetes will take a study capsule containing either a probiotic or a placebo and a daily portion of one of two different cereals daily for 6 months. Study followup will continue for 3 months after stopping the study interventions. The study will examine changes in blood tests including HbA1c ( a measure of blood glucose levels over the previous 8-12 weeks), fasting glucose, insulin and lipids. In addition, it will examine changes in blood pressure, weight, and waist circumference, body mass index and general well being/health related quality of life. Some study participants will also take part in individual interviews and group discussions aimed at helping us learn about the acceptability of the study interventions, and factors that would support long-term use of the interventions if they are proven to be effective. If the interventions are found to have clinically important beneficial effects group discussions will also be held with health professionals and others who might recommend the interventions. This is to find the best ways to ensure that the interventions are adopted.
Interventions
Study participants will be randomly allocated to these treatment arms, and interventions taken daily for 6 months.
Arm 1 - 1 capsule (containing Lactobacillus rhamnosus HN001 (6x10^9 colony forming units) + 139mg maltodextrin) and cereal mix (containing 40 g Uncle Toby’s rolled oats and 8g of OatWell® 28XF oatbran. ß-glucan dose 4 g, average total fibre 7.8g ).
Arm 2 - 1 placebo capsule and cereal mix (containing 40 g Uncle Toby’s rolled oats and 8g of OatWell® 28XF oatbran. ß-glucan dose 4 g,
Study participants will be randomly allocated to these treatment arms, and interventions taken daily for 6 months. Arm 1 - 1 capsule (containing Lactobacillus rhamnosus HN001 (6x10^9 colony forming units) + 139mg maltodextrin) and cereal mix (containing 40 g Uncle Toby’s rolled oats and 8g of OatWell® 28XF oatbran. ß-glucan dose 4 g, average total fibre 7.8g ). Arm 2 - 1 placebo capsule and cereal mix (containing 40 g Uncle Toby’s rolled oats and 8g of OatWell® 28XF oatbran. ß-glucan dose 4 g, average total fibre 7.8g). Arm 3 - 1 capsule (containing Lactobacillus rhamnosus HN001 (6x10^9 colony forming units) + 139 mg maltodextrin) and cereal mix (containing 35g Sanitarium cornflakes and 8g Non Dairy Creamer – C35 Average total fibre 0.9g) Arm 4 - 1 placebo capsule and cereal mix (containing 35g Sanitarium cornflakes and 8g Non Dairy Creamer – C35 Average total fibre 0.9g). Capsules will be taken orally once a day. Cereals taken once a day using a range of recipe options including cold cereal, hot porridge, or smoothies. Interventions will be dispensed at 3 month intervals and unused study capsules and cereals collected and counted by a member of the study not involved in fieldwork.
Sponsors
University of Otago, Wellington
Study design
Allocation
Randomised controlled trial
Intervention model
Factorial
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
For the Factorial design randomised controlled trial ( RCT): English speaking adults aged between 18 and 80 years with pre-diabetes defined as an HbA1c 41 - 49 mmol/mol. Participants will be included if their HbA1c is 41 - 44 mmol/mol within the four months before study enrolement, or 45-49 mmol/mol within 12 months. For Qualitative aspects of study: 1. Population for semi structured individual interviews, and participant focus groups. Four sub groups from the study participants of the RCT who self identify as Maori, Pacific, Indian/South Asian and Other, and who are allocated to Oat intervention arms of study. 2. Population for Health care provider focus groups - a purposeful sampling of disciplines identified as those who would implement study findings into practice if a clinically meaningful benefit of study interventions is demonstrated. For example, general practitioners, nurses, pharmacists, dietitians, health promoters, community health workers and health navigators, ,
Exclusion criteria
For RCT Pre-existing type 1 or type 2 diabetes or previous bariatric surgery Current pregnancy or planning to conceive during the duration of study enrolment Breastfeeding Current use of medications that modify blood sugar levels Unstable body weight (active weight loss/gain > 5 kg in prior 3 months) Weight > or equal to 200kg Abnormal thyroid function Has a serious immunological disorder that suppresses immune function A medical condition requiring immune suppressant drugs Requires long-term use of systemic antibiotics Structural heart disease (known valve abnormality or replacement history of endocarditis) or vascular implants except cardiac stents. Has coeliac disease or allergy or intolerance to any cereal components Does not agree to refrain from taking probiotic supplements during study period (except where medically advised). Uses fibre/prebiotic, (including beta glucan) supplements and is unable or unwilling to cease using these for the study duration Presence of a gastrointestinal disorder or medication that alters the digestion and absorption of nutrients Current significant renal disease (eGFR <30) Is participating in, or, has recently participated in another research study involving an intervention Plans to move from study centre during the period of the participant’s study enrolment Lives with another participant who is already enrolled in this study. Does not agree to refrain from donating blood for 2 months prior to each study visit Any other condition or situation, which in the view of investigators would affect the compliance or safety of the individual taking part.
Outcome results
None listed