Identifying the efficacy of the plant-origin flavonoid rutin in 2 doses (250mg and 500mg) and 2 delivery forms (yoghurt and capsules)

Comparison the pharmocokinetics properties of 2 doses of rutin (250mg and 500mg) in 2 delivery forms (yoghurt and capsules) in 6 healthy participants

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12618000630213

Enrollment

Registered

2018-04-20

Start date

2022-02-28

Completion date

2022-12-12

Last updated

2021-07-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The effect of dose and form of rutin delivery on pancreatic function has not been previously studied. As part of National Science Challenge (NSC) - High Value Nutrition (HVN) Metabolic program, the trial will assess pharmacokinetics of 2 doses; 250 and 500 mg rutin (once a day), in 2 delivery methods; encapsulated and in a food, in a crossover study over 24 hr in 6 healthy male and female participants. They will be a randomised to receive each treatment (rutin capsule, 250 mg; rutin capsule, 500 mg; yogurt with rutin 250 mg; yogurt with rutin 500 mg) with 2 week washout between treatments. Participants can complete 2 x encapsulated rutin or 2 x enriched food rutin; or all 4 treatments.

Interventions

Pharmacokinetics (PK) Study (one off dosing, 2 weeks wash-out) Rutin (250mg) enriched yogurt Rutin (500mg) enriched yogurt Rutin (250mg) in capsule Rutin (500mg) in capsules All participants take all deliery forms of rutin. Each capsule contain 250mg rutin, 1 capsule for the 250mg and 2 capsules for the 500mg. The rutin dose administration will be taken in no particular order and is randomised. The whole study will be monitor by direct observation by a research staff.

Study design

Allocation

Randomised controlled trial

Intervention model

Crossover

Primary purpose

Prevention

Masking

Blinded (masking used) (Subject, Caregiver)

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Healthy volunteers

Yes

Inclusion criteria

• Aged between 18-65 years • BMI between 23-35 kg/m2 • Fasting plasma glucose (FPG) < 5.6 mmol/L • Healthy, as per 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