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He Purongo Mo Nga Kai Hei Arai i Te Matehuka - Dietary Diabetes Prevention Study for Maori

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00208637
Enrollment
90
Registered
2005-09-21
Start date
2002-08-31
Completion date
2004-12-31
Last updated
2005-09-21

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

Conditions

Insulin Resistance

Keywords

Maori, insulin sensitivity, cardiovascular risk, diabetes prevention, diet modification

Brief summary

High protein diets are popular among Maori, especially on the East Coast of the North Island. The purpose of this study was to compare the metabolic effects of a moderate carbohydrate, high protein diet (MCHP) with a high carbohydrate-high fibre (HCHF) diet on insulin sensitivity in Maori at increased risk of developing diabetes and cardiovascular disease.

Detailed description

This was a 6-month pilot intervention study of self-identifying Maori participants in a randomised control trial conducted in Dunedin and Invercargill. The study consisted of three, two month phases and was conducted over a period of six months. Participants meeting all the inclusion criteria were randomised into three groups: moderate carbohydrate-high protein (MCHP), high carbohydrate-high fibre (HCHF) or a control group. Those randomised to the experimental diets were recommended an energy intake based on their current BMI levels. The aim of phase one was to achieve weight loss with weekly advice and support from the research team. The aim of phase two was for weight maintenance with continued weekly advice and support. Phase three consisted of a weight maintenance phase without support. Those in the control group were instructed to follow their own self selected diet plan. Outcome was determined by examining surrogate clinical endpoints. The clinical endpoints included the following recorded measurements of anthropometric measurements, bioelectrical impedance measurements, profile of mood state questionnaires, activity questionnaires, and three day diet records were collected at 0, 2, 4 and 6 month periods. Biochemical measures of lipid profile, fasting insulin and glucose, liver functions and uric acid levels were also conducted.

Interventions

BEHAVIORALmoderate carbohydrate, high protein diet (MCHP)
BEHAVIORALhigh carbohydrate-high fibre (HCHF) diet

Sponsors

Edgar National Centre for Diabetes Research
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
17 Years to 75 Years
Healthy volunteers
Yes

Inclusion criteria

* Self identify as Maori aged between 17-75 years * Male and female * Non-diabetic * Resident of Dunedin and Invercargill * BMI \>27 * Family history of T2D

Exclusion criteria

* The presence of diabetes, renal or liver failure, or any other medical condition which is unstable and for which potential partcipants are currently having active treatment.

Design outcomes

Primary

MeasureTime frame
Dietary intake as measured by 3-day weight diet records

Secondary

MeasureTime frame
Bioelectric Impedence
Weight
Waist circumference
Total cholesterol and lipid subfractions (LDL, HDL)
Fasting insulin
Blood pressure
Inflammatory markers
Urinary albumin:creatinine ratio
Quality of life
All measures to be compared at end of study (6 months)
Lipoprotein A + B

Countries

New Zealand

Outcome results

None listed

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