None listed
Conditions
Brief summary
As part of National Science Challenge (NSC) - High Value Nutrition (HVN) Metabolic program, the trial will investigate the efficacy of 500 mg rutin, in a double blind randomised 3arm placebo controlled parallel study over 6 months in male and female participants, with demonstrated prediabetes (fasting plasma glucose: = 5.6-6.9mmol/ L). Each participant will be required to consume once daily either: yogurt control + capsule control OR yogurt with 500 mg rutin + capsule control OR capsule 500 mg rutin + yogurt control, as part of their breakfast meal or as a later snack.
Interventions
Rutin Intervention Study (daily for 12 weeks)
Arm 1: Rutin (5o0mg) enriched yoghurt (200g) + control capsules (2x 250mg)
Arm 2: Control yoghurt (200g) + rutin 500mg capsule (2x 250mg)
OGTT will take place at baseline and 12 weeks.
Participants will be fasted for 10-12hrs prior to each study visit.
Participants will be asked to bring back the lids from the yoghurt pottles and the bottle containing capsules to check for compliance at each visit.
Yoghurt will be consumed in one setting in a pottle
Rutin Intervention Study (daily for 12 weeks) Arm 1: Rutin (5o0mg) enriched yoghurt (200g) + control capsules (2x 250mg) Arm 2: Control yoghurt (200g) + rutin 500mg capsule (2x 250mg) OGTT will take place at baseline and 12 weeks. Participants will be fasted for 10-12hrs prior to each study visit. Participants will be asked to bring back the lids from the yoghurt pottles and the bottle containing capsules to check for compliance at each visit. Yoghurt will be consumed in one setting in a pottle with 200g yoghurt (enriched with 500mg rutin). Control yoghurt will be plain yoghurt with vanilla custard flavour. The rutin-enriched yoghurt is also vanilla custard flavour.
Sponsors
University of Auckland Research Office
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
• Aged between 18-65 years • BMI between 23-35kg/m2 • Fasting plasma glucose (FPG) greater than or equal to 5.6 – 6.9 mmol/L • FINDRISC greather than or equal to 12 • Otherwise healthy by self-report
Exclusion criteria
• Type 2 or type 1 diabetes • Other significant disease including cardiovascular disease, pancreatic disease or cancer; or digestive disease including inflammatory bowel syndrome/disease (IBS/D), ulcerative colitis (UC), Crohn's disease • Medications controlling glycaemia • Current use of rutin or quercetin supplements • Recent body weight loss/gain >10% within previous 3 months or taking part in an active diet program; or current medications for weight loss • Dislike or unwilling to consume food items included in the study, or hypersensitivities or allergies to these foods, i.e. rutin allergy, lactose intolerant, does not consume yogurt • Pregnant or breastfeeding women • Unwilling/unable to comply with study protocol • Concurrent participation in other clinical studies, or such participation within the last 3 months
Outcome results
None listed