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Type 2 Diabetes MellitusPhase 1SLHDPNCT00707460

The Effect of a Traditional Dietary Intervention on Diabetes Mellitus and Cardiovascular Disease Risk Factors in a First Nation Community: A Pilot Study

A Phase 1 study testing Dietary Intervention (Macronutrient composition) in people with Type 2 Diabetes Mellitus and Cardiovascular Disease, run by University of Toronto at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to evaluate whether or not a traditional First Nations diet (high protein) and/or a dietary intervention based upon current Canadian dietary recommendations (high carbohydrate/high fiber) effects risk factors for type 2 diabetes mellitus and/or cardiovascular disease in a remote fly in… Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
What is being tested?
Dietary Intervention (Macronutrient composition)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteCanada
Study dates
May 2008to Jun 2009
Phase
Phase 1
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 18 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Age 18-50 years
  • Sandy Lake First Nation permanent resident, with total travel outside of the community less than one month per year.
  • Aboriginal Ethnicity
  • BMI = 23-40 kg/m2
  • According to Prochaska and DiClemente's transtheoretical model, also referred to as the Stages of Change Theory, potential participants must be at least at the contemplation stage.
  • Willing and able to follow the study protocol

Who cannot join

  • DM detected by OGTT
  • Pregnancy, lactation or intention to become pregnant within six months from recruitment
  • Any pre-existing condition compromising macronutrient metabolism, quality of life or ability to participate according to protocol. Individuals with the following conditions will be excluded automatically: heart disease, cerebrovascular disease, diagnosed HIV/AIDS, cancer, emphysema, liver or kidney disease
  • Insurmountable language barriers

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • Sandy Lake Health & Diabetes Project Research Office

    Sandy Lake, Ontario, P0V 1V0

Other trials in Canada

About this study

Official title: Objective 3: Pilot Dietary Trial; The Sandy Lake Health & Diabetes Project (SLHDP): Understanding and Addressing Metabolic Syndrome, Diabetes and Associated Complications in Aboriginal Canadians

The purpose of this study is to evaluate whether or not a traditional First Nations diet (high protein) and/or a dietary intervention based upon current Canadian dietary recommendations (high carbohydrate/high fiber) effects risk factors for type 2 diabetes mellitus and/or cardiovascular disease in a remote fly in First Nations community (Sandy Lake First Nation).

This pilot has been developed in conjunction with Sandy Lake First Nation to answer the research question: Will a traditional diet or a diet based upon current Canadian dietary recommendations result in decreasing risk for type 2 diabetes in Sandy Lake?

Read the detailed description

Eligible participants will be randomized to one of 3 groups. Potential participants will have an oral glucose tolerance test (OGTT) during the screening visit to evaluate if they are eligible for the study. Those who meet the inclusion criteria will be stratified according to diagnoses (normal glucose tolerance or impaired glucose tolerance) and randomized to one of three diet groups for a 6 month period.

The following is a description of the 3 study arms/diets:

Group 1: The (Food choice) Control Group

Group 2 (The "Traditional Food" [TD] Group) will receive instruction to follow a diet that reflects the traditional nutrient intake pattern of this population. Briefly, participants will be encouraged to consume, wild meats (i.e. moose, duck, rabbit, and beaver), fish, local berries and other foods obtained from the land ("bush foods"). When these foods are not available, acceptable store bought substitutes will be encouraged (i.e. low fat beef \& pork, skinless chicken, canned/frozen fish, store bought fruit and frozen berries). Traditional preparation methods will also be encouraged (i.e. boiling, smoking, and BBQing), and non-traditional foods (i.e. high saturated fat, high carbohydrate, processed foods, high sodium foods, "junk foods", convenience foods or foods including trans fats) and preparation methods (i.e. frying) will be strongly discouraged. The diet has been developed by a Registered Dietitian (RD) with the feedback of Sandy Lake First Nation community members, Dr. Anthony Hanley and with the assistance of tools and documents obtained from Health Canada's website.

Group 3 (The "Healthy Store-bought Food" [HSF] Group) will receive instruction to follow a diet that reflects the results of nutritional epidemiological research on diabetes prevention in this and other populations. Participants will be encouraged to consume a diet comprised of foods as per the Canadian Food Guide to Healthy Eating, Health Canada. It is estimated that HSF group participants will have a macronutrient profile that reflects current "Acceptable Macronutrient Distribution Range (AMDR)", as per the Institute of Medicine (2005) and Health Canada (2007) if they adhere to the education provided. Recommendations will promote a high fibre, low trans- and saturated fat diet including whole grains, fruit and vegetables, mono- and poly-unsaturated fat sources, lean meat and poultry and a low fat dairy profile. "Junk food" (i.e. soda pop, chips, and chocolate bars) will not be forbidden, however will be regarded as a "choose less often" food. Convenience/Ready-Made foods will be allowed, however, healthier choices will be highlighted during the education sessions.

All three groups will be provided with education on serving size and portion control to promote compliance and to ensure that all groups are obtaining useful nutritional information by participating in the study. A major component of the SLHDP is to promote capacity building and long term healthy lifestyle in the community. Portion control will be treated as a controlled variable and will promote identical caloric intake between and within groups.

Nutrition Education and Lifestyle Data Collection:

Community support staff will be trained by the Research Coordinator/ Registered Dietitian (RD) to conduct baseline and follow-up sessions when the RD is not stationed in Sandy Lake. The Research Coordinator/ RD will be available 9am-5pm (week days)for nutrition consult and information support. During follow-up sessions data will be collected (see outcome measures) and data collection tools, food provisions and education will be provided.

Metabolic/Anthropometric Data Collection:

A Community (member) Registered Practical Nurse will be responsible for the metabolic and anthropometric data collection (see outcome measures). This RPN has held this role since the beginning of the SLHDP.

Being tested
Dietary Intervention (Macronutrient composition)
Keywords
Diabetes, Cardiovascular, Obesity, First.Nation, Aboriginal (Health), Dietary, Intervention, Nutrition, Traditional (Diet), Sandy Lake (Health & Diabetes Project), (High) protein, (High) fibre (er), (Low) carbohydrate
Medical subject headings
Diabetes Mellitus, Type 2, Cardiovascular Diseases, Obesity, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dietary Intervention (Macronutrient composition)Behavioural

    Also called high protein diet = traditional diet, high fiber diet = healthy store-bought diet, high carbohydrate diet = healthy store-bought diet

    The Traditional Diet and Healthy Store-Bought arms differ from the control group and one another by their macronutrient composition. Please, see design section for more detail on this item.

    All groups are exposed to nutrition education on serving size and portion size.

Study groups in NCT00707460
Study groupRoleWhat they receive
1Active comparatorPlease, see design section for details.
Receives: Behavioral: Dietary Intervention (Macronutrient composition)
2ExperimentalTraditional Diet Please, see design section for details.
Receives: Behavioral: Dietary Intervention (Macronutrient composition)
3ExperimentalHealthy Store-bought Diet Please, see design section for details.
Receives: Behavioral: Dietary Intervention (Macronutrient composition)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pilot Study: no formal primary outcome measure. There is no noted safety issue for this study; although adverse/side effects and/or symptoms will be closely monitored by the RPN and community research staff.

    Measured: 6 months

Secondary outcomes (6)
  1. Indicators of glycemic control: fasting blood glucose, insulin resistance, fasting serum insulin, liver function tests, urine creatinine, sodium and other urinary nutritional indicators (from the same urine sample) and full lipid profile.

    Measured: 6 months

  2. Blood pressure (BP) and heart rate

    Measured: 6 months

  3. Non-traditional CVD risk factors: serum C-reactive protein (CRP) and adiponectin.

    Measured: 6 months

  4. Anthropometric measurements: change in body mass (kg)/BMI over the study period, change in percent body fat and percent lean body mass (bio-electrical impedance analysis [BIA]), and waist and hip circumference.

    Measured: 6 months

  5. Compliance of the sample using three day diet records and appointment attendance. Participants' barriers to compliance will be assessed via the questionnaire(s), diet records and study chart notes.

    Measured: 6 months

  6. Future dietary intervention feasibility will be assessed by 24-hour recalls/ diet records, appointment attendance, participant and community staff feedback, and questionnaire completion.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jun 2008 (estimated)
  2. Study startMay 2008
  3. Primary completionJun 2009
  4. Study completionJun 2009

Resources

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 1
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00707460
Sponsor's protocol ID
22419
Other IDs
MOP44076
Acronym
SLHDP
Status last verified
Jan 2010
First submitted
26 Jun 2008
Last updated
20 Jan 2010
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Dietary Intervention (Macronutrient composition) in people with Type 2 Diabetes Mellitus and Cardiovascular Disease, run by University of Toronto at 1 site in Canada.

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 4 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 20 Jan 2010. 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 Canada. 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.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Pilot Study: no formal primary outcome measure. There is no noted safety issue for this study; although adverse/side effects and/or symptoms will be closely monitored by the RPN and community research staff. (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 20 Jan 2010.

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