The effect of the Nutrition-Care Gluco-Metabolism Formula on glucose levels in pre-diabetic adults: The Gluco-Metabolism Trial

Randomised double-blinded placebo-controlled trial of 12 weeks duration investigating the tolerability and effectiveness of the Nutrition-Care Gluco-Metabolism Formula on glucose control in pre-diabetic adults.

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12619001357145

Enrollment

Registered

2019-10-03

Start date

2019-10-08

Completion date

2020-04-30

Last updated

2019-10-07

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

Conditions

None listed

Brief summary

Prevention and early diagnosis of diabetes is key to avoid diabetes-related complications. In 2018, 2 million Australians are estimated to have pre-diabetes and are at high-risk of developing type 2 diabetes. The Nutrition-Care Gluco-Metabolism Formula contains a mixture of herbs and nutrients, which have been shown to be beneficial for balancing blood glucose levels in the blood. In this randomised double-blind placebo-controlled 12-week trial we aim to assess the tolerability and efficacy of the Gluco-Metabolism Formula for glucose control in pre-diabetics.

Interventions

Randomised double-blind placebo-controlled trial of 12 weeks duration investigating the effect and tolerability of the Nutrition-Care Gluco-Metabolism-Herbal Formula on glucose levels in pre-diabetic adults. The intervention will comprise of 2x3 Gluco-Metabolism tablets (active group) or placebo (control group) daily for 12 weeks. The active tablets contain a gymnema silvestre, cinnamon cassia, bitter melon, fenugreek, nigella sativa, portulaca oleracea, alpha-lipoic acid, chromium picolinate,

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1) Pre-diabetes: FPG: 5.5-7.0 mmol/l and/or PPG: 7.8-11.1 mmol/l Assessment done with Accu-Chek Mobile Blood Glucose Meter (Roche) & disposable strips

Exclusion criteria

Diagnosed with diabetes, on diabetic medication (e.g. insulin, metformin) or glucose control supplements Diagnosed with chronic illness (cancer, non-fatty-liver), or pregnancy or breastfeeding Taking vitamin C supplements or IVC, and not willing to stop for the length of the trial (as vitamin c can falsify plasma glucose readings) If FPG or PPG are in the diabetic range during screening, the volunteer won’t be eligible to participate in the trial, and will be referred to a GP for follow-up. Have had recent surgery, or planning on any surgery, or change of medication during the 3-4 month study Intolerance or allergies to ingredients in Gluco-Metabolism formula

Outcome results