Optimising Health in Type 1 Diabetes

The Optimal Diet for Optimising Health in Type 1 Diabetes

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02903615

Enrollment

Registered

2016-09-16

Start date

2016-09-30

Completion date

2020-06-30

Last updated

2022-03-22

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

Conditions

Diabetes Mellitus

Keywords

glucose, inflammation

Brief summary

Type 1 diabetes is an autoimmune condition where circulating immune cells destroy the beta-cells in the pancreas that make insulin, resulting in a degree of insulin deficiency, whereby blood glucose levels rise and diabetes develops. When there is severe insulin deficiency, life-threatening ketoacidosis can develop. Treatment is lifelong insulin replacement therapy; dietary intervention is a also cornerstone of glucose management. The Optimise Diet is a multi-pronged diet based on best health principles: to minimise blood glucose rises after eating, reduce the immune cells involved in destruction of the insulin-secreting beta-cells, and improve the gut microbiome and systemic inflammation. In this study, its effects will be compared to the Standard Diabetes Diet that is currently recommended in Australia and internationally.

Detailed description

The rationale for this study is to determine whether a diet based on recent scientific advances in diet-induced inflammation, will improve diabetes care in people with type 1 diabetes.

Interventions

OTHERNovel diet

Novel diet to optimise glucose levels and minimise systemic inflammation: altered macronutrient composition: lower carbohydrate, Mediterranean-style, prebiotic fibre focus.

OTHERStandard diet

Standard diabetes diet recommendations

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Yes

Inclusion criteria

* type 1 diabetes

Exclusion criteria

* Women lactating, pregnant or of childbearing potential who are not willing to avoid becoming pregnant during the study.

Design outcomes

Primary

Measure	Time frame	Description
Glucose control	3 months	HbA1c

Secondary

Measure	Time frame	Description
Inflammation	3 months	Circulating immune cells numbers
Gut microbiome	3 months	Gut flora subtypes
C-peptide	3 months	Urinary excretion
postprandial glucose excursion	3 months	postprandial glucose excursion
Follow-up of glycemic control and insulin secretion	12 and 24 months	HbA1c, urinary C-peptide

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026