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Fibre, protein and insulin resistance diet study

A randomised, controlled dietary intervention to evaluate the effect on a high protein and high fibre diet on insulin sensitivity and markers of cardiovascular disease risk in healthy, overweight women.

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12607000154404
Acronym
IR-DIET
Enrollment
72
Registered
2007-03-05
Start date
2007-03-12
Completion date
Unknown
Last updated
2020-01-13

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

Conditions

None listed

Brief summary

Insulin resistance (IR) is an underlying cause of most cases of type 2 diabetes. The prevalence of diagnosed diabetes in New Zealand is estimated to be 4% in the general New Zealand population and as high as 12% in Maori and Pacific Peoples. These are likely to be underestimates and the prevalence is further increased when including estimates of undiagnosed cases. Furthermore diabetes is believed to be increasing at an alarming rate in New Zealand and throughout the world. Given that IR is associated with severe health risks including obesity, high blood pressure, dyslipidaemia (abnormal blood fats), raised blood sugar and damage to blood vessels it is not surprising that insulin resistance is also associated with a significant increase in cardiovascular disease (CVD) risk in both diabetic and non-diabetic adults. Lifestyle interventions indicate that improvements in insulin sensitivity of 20-30% may be achievable. However we currently have little indication of which dietary modifications will achieve the greatest change. This study will attempt to determine the extent to which IR and other related risk factors for cardiovascular disease can be reduced by a diet high in both dietary fibre and dietary protein, both with and without weight loss.

Interventions

Participants will be randomised to one of 2 diets for 10 weeks. The diets will be: 1) a control diet based on best practices for nutritional counselling and the New Zealand dietary guidelines and food pyramid Participants will be required to maintain their baseline weight for the first 4 weeks. From week 5 participants will be counselled to eat as much as required to feel satisfied while adhering to their dietary regime. Participants will meet with a study researcher on a weekly basis for 20

Participants will be randomised to one of 2 diets for 10 weeks. The diets will be: 1) a control diet based on best practices for nutritional counselling and the New Zealand dietary guidelines and food pyramid Participants will be required to maintain their baseline weight for the first 4 weeks. From week 5 participants will be counselled to eat as much as required to feel satisfied while adhering to their dietary regime. Participants will meet with a study researcher on a weekly basis for 20 minute nutritional counselling sessions and to be weighed.

Sponsors

Dr Kirsten McAuley
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

Overweight; BMI = 27 kg/m2 and weight < 120 kg or BMI >23 kg/m2 and a direct family history of type 2 diabetes.Normal or impaired glucose tolerance.Weight stable over last 3 months and willing to maintain weight initially.Prepared to undergo dietary intervention and eat substantial amounts of dietary fibre including wholegrains, legumes and pulses.

Exclusion criteria

No diabetes, history of cardiovascular disease, or renal or hepatic failure.Not suffering from any other major medical condition.No psychiatric illness, drug or alcohol dependence that would affect ability to adhere to the dietary guidelines.Not pregnant or lactating.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026