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.
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
- Conditions the study is for
- Type 2 Diabetes Mellitus, Cardiovascular Disease, Obesity
- What is being tested?
- Dietary Intervention (Macronutrient composition)
- Type of treatment
- Lifestyle or therapy programme
- 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
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.
- Conditions
- Type 2 Diabetes Mellitus, Cardiovascular Disease, Obesity
- 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 group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Please, see design section for details. Receives: Behavioral: Dietary Intervention (Macronutrient composition) |
| 2 | Experimental | Traditional Diet
Please, see design section for details. Receives: Behavioral: Dietary Intervention (Macronutrient composition) |
| 3 | Experimental | Healthy 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.
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)
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
Blood pressure (BP) and heart rate
Measured: 6 months
Non-traditional CVD risk factors: serum C-reactive protein (CRP) and adiponectin.
Measured: 6 months
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
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
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.
- First posted30 Jun 2008 (estimated)
- Study startMay 2008
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by University of TorontoThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Investigators
- Thomas MS Wolever, DM, PhD, Study director, University of Toronto
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
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00707460
- Acronym / sponsor ID
- SLHDP / 22419
- Conditions
- Type 2 Diabetes Mellitus, Cardiovascular Disease, Obesity
- Keywords
- Diabetes, Cardiovascular, Obesity, First.Nation, Aboriginal (Health), Dietary, Intervention, Nutrition
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- May 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 30 Jun 2008 (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.
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?
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Behavioral: Dietary Intervention (Macronutrient composition)Please, see design section for details. |
| 2 | Experimental | Behavioral: Dietary Intervention (Macronutrient composition)Traditional Diet Please, see design section for details. |
| 3 | Experimental | Behavioral: Dietary Intervention (Macronutrient composition)Healthy Store-bought Diet Please, see design section for details. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| Dietary Intervention (Macronutrient composition)Also: high protein diet = traditional diet, high fiber diet = healthy store-bought diet, high carbohydrate diet = healthy store-bought dietThe 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. | Behavioural | 1, 2, 3 |
Primary outcome
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
6 secondary outcomes
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.
Time frame: 6 months
Blood pressure (BP) and heart rate
Time frame: 6 months
Non-traditional CVD risk factors: serum C-reactive protein (CRP) and adiponectin.
Time frame: 6 months
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.
Time frame: 6 months
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.
Time frame: 6 months
Future dietary intervention feasibility will be assessed by 24-hour recalls/ diet records, appointment attendance, participant and community staff feedback, and questionnaire completion.
Time frame: 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 20 Jan 2010.
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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.
Thomas MS Wolever, DM, PhD study director
University of Toronto
1 site in 1 country: see every site and its status.
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.