Diabetes Mellitus, Type 2Phase 2NCT00334919
RCT of the Naturopathic Anti-Inflammatory Diet
A Phase 2 study testing Diet (Anti-Inflammatory or standard diabetic diet) in people with Diabetes Mellitus, Type 2 and Prediabetes, run by National University of Natural Medicine at 1 site in United States.
Trial summary
The purpose of this study is to determine if the naturopathic Anti-Inflammatory Diet results in reduced inflammation and a better response by the immune system when compared to a standard diabetic diet based on the current American Diabetes Association guidelines. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, Prediabetes
- What is being tested?
- Diet (Anti-Inflammatory or standard diabetic diet)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- May 2006to Dec 2007
- Phase
- Phase 2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BMI: 25-45 kg/m2
- Age 18-75 yrs
- Diagnosed with type 2 diabetes or pre-diabetes
- At risk for type 2 diabetes. Must meet 2 of the following 3 criteria: BMI 30-45 kg/m2, age 50 or older, and/or family history of type 2 diabetes
- Fasting blood glucose of 100-200 mg/dl
- Provide informed consent
Who cannot join
- Current major debilitating mental or physical illness that would interfere with participation (as determined by the participant's medical history)
- Taking diabetic medication other than sulfonylurea
- Taking Gymnema silvestra (a naturopathic diabetes treatment)
- Taking medications that have anti-inflammatory affects (lipid lowering agents, NSAIDS, COX 2 inhibitors, aspirin, HRT, oral contraceptives, testosterone, seizure medications)
- Taking weight loss medications
- Severe renal, hepatic, or heart disease
Show all 19Show fewer
- Triglycerides >500 mg/dL
- Bulimia
- Pregnancy or lactation
- Current excessive use of alcohol
- Current/recent chronic use of recreational drugs
- Smoker
- More than 4 hours/week of aerobic exercise
- Have gained or lost more than 15 pounds during previous 6 months
- Planning on moving out of the area in the next 4 months
- Is a participant in another medical research study
- Is following a weight loss diet
- Is unwilling to accept random assignment of the experimental diets
- Food preferences and/or allergies that will interfere with consumption of experimental diet
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health & Science University General Clinical Research Center
Portland, Oregon, 97239
About this study
Official title: Randomized Clinical Trial of the Naturopathic Anti-Inflammatory Diet
The purpose of this study is to determine if the naturopathic Anti-Inflammatory Diet results in reduced inflammation and a better response by the immune system when compared to a standard diabetic diet based on the current American Diabetes Association guidelines.
Read the detailed description
This study will test the effects of two different diets on the immune system and inflammation in diabetes and pre-diabetes. These diets are the "Anti-Inflammatory Diet" (AI Diet) used by many naturopathic doctors and a standard diabetic diet based on the American Diabetes Association recommendations (ADA Diet). The AI diet excludes wheat, dairy products, eggs, red meat, caffeine, alcohol, peanuts and certain fruits and vegetables. The ADA diet includes most foods but controls the amount of each of the food groups.
Naturopathic physicians often use healthful diets to treat diseases but many of these diets have not been compared to usual medical diet treatments. We will be looking at blood markers that show how the immune system responds to the different diets. We are expecting that the AI diet will result in less inflammation and a better response by the immune system than the ADA diet. We will also be looking at levels of blood lipids and glucose to see any effects on these risk factors.
- Conditions
- Diabetes Mellitus, Type 2, Prediabetes
- Being tested
- Diet (Anti-Inflammatory or standard diabetic diet)
- Keywords
- Diabetes, Pre-Diabetes, Anti-Inflammatory Diet, Diet Study, Inflammation, Diabetic Diet
- Medical subject headings
- Diabetes Mellitus, Type 2, Prediabetic State, Diabetes Mellitus, Glucose Intolerance, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diet (Anti-Inflammatory or standard diabetic diet)Behavioural
6 weeks standard ADA diet, then randomized to either ADA or antiinflammatory (AI) diet for 6 weeks
What is being measured
The primary outcome is the main question the study is designed to answer.
Cytokines
Measured: 13 weeks
Secondary outcomes (3)
Glucose
Measured: 113 weeks
Weight
Measured: 13 weeks
Lipids
Measured: 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2006 (estimated)
- Study startMay 2006
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University of Natural Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Investigators
- Patricia Elmer, PhD, Principal investigator, National College of Naturopathic Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00334919
- Sponsor's protocol ID
- R21AT002374-01A1
- Other IDs
- R21AT002374-01A1
- Status last verified
- May 2009
- First submitted
- 6 Jun 2006
- Last updated
- 24 Jun 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial of the Naturopathic Anti-Inflammatory Diet
- ClinicalTrials.gov ID
- NCT00334919
- Acronym / sponsor ID
- R21AT002374-01A1
- Conditions
- Diabetes Mellitus, Type 2, Prediabetes
- Keywords
- Diabetes, Pre-Diabetes, Anti-Inflammatory Diet, Diet Study, Inflammation, Diabetic Diet
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- National University of Natural MedicineUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- May 2006
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 8 Jun 2006 (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 determine if the naturopathic Anti-Inflammatory Diet results in reduced inflammation and a better response by the immune system when compared to a standard diabetic diet based on the current American Diabetes Association guidelines.
Detailed description
This study will test the effects of two different diets on the immune system and inflammation in diabetes and pre-diabetes. These diets are the "Anti-Inflammatory Diet" (AI Diet) used by many naturopathic doctors and a standard diabetic diet based on the American Diabetes Association recommendations (ADA Diet). The AI diet excludes wheat, dairy products, eggs, red meat, caffeine, alcohol, peanuts and certain fruits and vegetables. The ADA diet includes most foods but controls the amount of each of the food groups.
Naturopathic physicians often use healthful diets to treat diseases but many of these diets have not been compared to usual medical diet treatments. We will be looking at blood markers that show how the immune system responds to the different diets. We are expecting that the AI diet will result in less inflammation and a better response by the immune system than the ADA diet. We will also be looking at levels of blood lipids and glucose to see any effects on these risk factors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- BMI: 25-45 kg/m2
- Age 18-75 yrs
- Diagnosed with type 2 diabetes or pre-diabetes
- At risk for type 2 diabetes. Must meet 2 of the following 3 criteria: BMI 30-45 kg/m2, age 50 or older, and/or family history of type 2 diabetes
- Fasting blood glucose of 100-200 mg/dl
Key exclusion criteria (19 listed)
- Current major debilitating mental or physical illness that would interfere with participation (as determined by the participant's medical history)
- Taking diabetic medication other than sulfonylurea
- Taking Gymnema silvestra (a naturopathic diabetes treatment)
- Taking medications that have anti-inflammatory affects (lipid lowering agents, NSAIDS, COX 2 inhibitors, aspirin, HRT, oral contraceptives, testosterone, seizure medications)
- Taking weight loss medications
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 |
|---|---|---|
| Diet (Anti-Inflammatory or standard diabetic diet)6 weeks standard ADA diet, then randomized to either ADA or antiinflammatory (AI) diet for 6 weeks | Behavioural | – |
Primary outcome
Cytokines
Time frame: 13 weeks
3 secondary outcomes
Glucose
Time frame: 113 weeks
Weight
Time frame: 13 weeks
Lipids
Time frame: 13 weeks
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 24 Jun 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.
Patricia Elmer, PhD principal investigator
National College of Naturopathic Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Diet (Anti-Inflammatory or standard diabetic diet) in people with Diabetes Mellitus, Type 2 and Prediabetes, run by National University of Natural Medicine at 1 site in United States.
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 19 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 24 Jun 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 United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Cytokines (time frame: 13 weeks). 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 24 Jun 2010.