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

Not Applicable

• Conditions: Pre-diabetes; Metabolic and Endocrine - Diabetes

• Registration Number: ACTRN12619001357145
• Lead Sponsor: AProf Dr Karin Ried

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-10-03
• Last Update Posted: 7 October 2019

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Fasting plasma glucose measured by fingerprick test and blood Glucose Meter[4,8,12 weeks of intervention compared to baseline];Post-prandial plasma glucose measured by fingerprick test and blood Glucose Meter[12 weeks compared to baseline];Ambulatory glucose profile (incl mean glucose levels) by continuous glucose monitoring using a permanently fitted Glucose Sensor (Abbott Freestyle Libre)[Twice continuously over a 2 week period: At enrolment (weeks 1+2) and at end of the study (weeks 11+12) ]

Secondary Outcome Measures

Name	Time	Method
HbA1c by microspot blood test[0 and 12 weeks];Visceral fat by body impedance analysis (BIA)[0 and 12 weeks];Zonulin stool spot test [0 and 12 weeks];fasting insulin by blood test[0 and 12 weeks]