NCT00208637

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (planned)
• Sponsor: Edgar National Centre for Diabetes Research · Academic / Other
• Sex: All
• Age: 17 Years – 75 Years
• Healthy volunteers: Accepted

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.

Conditions

• Insulin Resistance

Interventions

Type	Name	Description
BEHAVIORAL	moderate carbohydrate, high protein diet (MCHP)
BEHAVIORAL	high carbohydrate-high fibre (HCHF) diet

Timeline

• Start date: 2002-08-01
• Completion: 2004-12-01
• First posted: 2005-09-21
• Last updated: 2005-09-21

Locations

1 site across 1 country: New Zealand