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Completed

NCT Number: NCT00208637

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

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.

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Key information

Age range

17 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Edgar National Centre for Diabetes Research

Dunedin, Otago, 9001, New Zealand

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

moderate carbohydrate, high protein diet (MCHP)

Behavioral

high carbohydrate-high fibre (HCHF) diet

Behavioral

Primary outcomes

  1. Dietary intake as measured by 3-day weight diet records

Secondary outcomes

  1. Blood pressure

  2. Bioelectric Impedence

  3. Weight

  4. Waist circumference

  5. Total cholesterol and lipid subfractions (LDL, HDL)

  6. Fasting insulin

  7. Lipoprotein A + B

  8. Inflammatory markers

  9. Urinary albumin:creatinine ratio

  10. Quality of life

  11. All measures to be compared at end of study (6 months)

Sponsors and collaborators

Lead sponsor

Edgar National Centre for Diabetes Research

Other

Registry information

Important dates

Study start
2002
Study completion
2004
First posted
Sep 21, 2005
Registry last updated
Sep 21, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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