NCT00208637

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2002

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2002

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2004

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
Last Updated

September 21, 2005

Status Verified

September 1, 2005

First QC Date

September 13, 2005

Last Update Submit

September 13, 2005

Conditions

Insulin Resistance

Keywords

Maoriinsulin sensitivitycardiovascular riskdiabetes preventiondiet modification

Outcome Measures

Primary Outcomes (1)

  • Dietary intake as measured by 3-day weight diet records

Secondary Outcomes (11)

  • Blood pressure

  • Bioelectric Impedence

  • Weight

  • Waist circumference

  • Total cholesterol and lipid subfractions (LDL, HDL)

  • +6 more secondary outcomes

Interventions

moderate carbohydrate, high protein diet (MCHP)BEHAVIORAL
high carbohydrate-high fibre (HCHF) dietBEHAVIORAL

Eligibility Criteria

Age17 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Edgar National Centre for Diabetes Research

Dunedin, Otago, 9001, New Zealand

Location

Related Publications (1)

  • Brooking LA, Williams SM, Mann JI. Effects of macronutrient composition of the diet on body fat in indigenous people at high risk of type 2 diabetes. Diabetes Res Clin Pract. 2012 Apr;96(1):40-6. doi: 10.1016/j.diabres.2011.11.021. Epub 2011 Dec 16.

    PMID: 22178004DERIVED

Related Links

MeSH Terms

Conditions

Insulin Resistance

Interventions

Diet, High-ProteinDiet

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Diet TherapyNutrition TherapyTherapeuticsNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Lorraine Brooking, BSc, MA

    Edgar National Centre for Diabetes Research, Dunedin, NZ

    PRINCIPAL INVESTIGATOR

  • Jim I Mann, FRACP, PhD

    Edgar National Centre for Diabetes Research, Dunedin, NZ

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Study Start

August 1, 2002

Study Completion

December 1, 2004

Last Updated

September 21, 2005

Record last verified: 2005-09

Locations

NZ(1)