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| Sponsored by: |
Edgar National Centre for Diabetes Research |
|---|---|
| Information provided by: | Edgar National Centre for Diabetes Research |
| ClinicalTrials.gov Identifier: | NCT00208637 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Insulin Resistance |
Behavioral: moderate carbohydrate, high protein diet (MCHP) Behavioral: high carbohydrate-high fibre (HCHF) diet |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
| Estimated Enrollment: | 90 |
| Study Start Date: | August 2002 |
| Estimated Study Completion Date: | December 2004 |
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.
Eligibility| Ages Eligible for Study: | 17 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| New Zealand, Otago | |
| Edgar National Centre for Diabetes Research | |
| Dunedin, Otago, New Zealand, 9001 | |
| Principal Investigator: | Lorraine Brooking, BSc, MA | Edgar National Centre for Diabetes Research, Dunedin, NZ |
| Study Director: | Jim I Mann, FRACP, PhD | Edgar National Centre for Diabetes Research, Dunedin, NZ |
More Information
| Study ID Numbers: | Kai Study |
| Study First Received: | September 13, 2005 |
| Last Updated: | September 13, 2005 |
| ClinicalTrials.gov Identifier: | NCT00208637 History of Changes |
| Health Authority: | New Zealand: Health and Disability Ethics Committees |
|
Maori insulin sensitivity cardiovascular risk diabetes prevention diet modification |
|
Hyperinsulinism Metabolic Diseases Diabetes Mellitus Insulin Resistance |
Glucose Metabolism Disorders Metabolic Disorder Insulin |
|
Hyperinsulinism Metabolic Diseases Insulin Resistance Glucose Metabolism Disorders |
