Insulin ResistanceNCT00208637
He Purongo Mo Nga Kai Hei Arai i Te Matehuka - Dietary Diabetes Prevention Study for Maori
A study testing moderate carbohydrate, high protein diet (MCHP) and high carbohydrate-high fibre (HCHF) diet in people with Insulin Resistance, run by Edgar National Centre for Diabetes Research at 1 site in New Zealand.
Trial 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… Read more about this study
- Who is it for?
- Ages 17 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Insulin Resistance
- What is being tested?
- moderate carbohydrate, high protein diet (MCHP) and high carbohydrate-high fibre (HCHF) diet
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 90 participants
- Where
- 1 siteNew Zealand
- Study dates
- Aug 2002to Dec 2004
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 75 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
New Zealand1 site
Edgar National Centre for Diabetes Research
Dunedin, Otago, 9001
About this study
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.
Read the 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
- Being tested
- moderate carbohydrate, high protein diet (MCHP), high carbohydrate-high fibre (HCHF) diet
- Keywords
- Maori, insulin sensitivity, cardiovascular risk, diabetes prevention, diet modification
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
moderate carbohydrate, high protein diet (MCHP)Behavioural
high carbohydrate-high fibre (HCHF) dietBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Fasting insulin
Lipoprotein A + B
Inflammatory markers
Urinary albumin:creatinine ratio
Quality of life
All measures to be compared at end of study (6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startAug 2002
- Study completionDec 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Insulin ResistanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants
Sponsor and investigators
- Lead sponsor
- Edgar National Centre for Diabetes Research
- Sponsor type
- University, hospital or other
- Investigators
- Lorraine Brooking, BSc, MA, Principal investigator, Edgar National Centre for Diabetes Research, Dunedin, NZJim I Mann, FRACP, PhD, Study director, Edgar National Centre for Diabetes Research, Dunedin, NZ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00208637
- Sponsor's protocol ID
- Kai Study
- Status last verified
- Sep 2005
- First submitted
- 13 Sep 2005
- Last updated
- 21 Sep 2005
- Results posted
- No
Publications
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.
PubMed 22178004
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- He Purongo Mo Nga Kai Hei Arai i Te Matehuka - Dietary Diabetes Prevention Study for Maori
- ClinicalTrials.gov ID
- NCT00208637
- Acronym / sponsor ID
- Kai Study
- Conditions
- Insulin Resistance
- Keywords
- Maori, insulin sensitivity, cardiovascular risk, diabetes prevention, diet modification
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants
- Lead sponsor
- Edgar National Centre for Diabetes ResearchUniversity, hospital or other
- Study start
- Aug 2002
- Study completion
- Dec 2004
- First posted
- 21 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 17 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Self identify as Maori aged between 17-75 years
- Male and female
- Non-diabetic
- Resident of Dunedin and Invercargill
- BMI >27
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| moderate carbohydrate, high protein diet (MCHP) | Behavioural | – |
| high carbohydrate-high fibre (HCHF) diet | Behavioural | – |
Primary outcome
Dietary intake as measured by 3-day weight diet records
11 secondary outcomes
Blood pressure
Bioelectric Impedence
Weight
Waist circumference
Total cholesterol and lipid subfractions (LDL, HDL)
Fasting insulin
Lipoprotein A + B
Inflammatory markers
Urinary albumin:creatinine ratio
Quality of life
All measures to be compared at end of study (6 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2005.
- Derived from this study: PubMed 22178004Brooking 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lorraine Brooking, BSc, MA principal investigator
Edgar National Centre for Diabetes Research, Dunedin, NZ
Jim I Mann, FRACP, PhD study director
Edgar National Centre for Diabetes Research, Dunedin, NZ
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing moderate carbohydrate, high protein diet (MCHP) and high carbohydrate-high fibre (HCHF) diet in people with Insulin Resistance, run by Edgar National Centre for Diabetes Research at 1 site in New Zealand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dietary intake as measured by 3-day weight diet records. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00208637, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2005.