Status:
COMPLETED
Changes in Inflammatory State in Asian Americans Changing From Traditional Asian Diets to American Diet - a Pilot Study
Lead Sponsor:
Joslin Diabetes Center
Collaborating Sponsors:
Sunstar, Inc.
Conditions:
Diabetes
Insulin Resistance
Eligibility:
All Genders
25-55 years
Phase:
NA
Brief Summary
We hypothesize that Asian Americans compared to Caucasians, will be at higher risk of developing a pro-inflammatory state that may contribute to the development of heart disease and diabetes when they...
Eligibility Criteria
Inclusion
- Caucasian or Far-East Asian decent
- Ages between 25 - 55 years old
- Has family history of diabetes defined as having a first degree relative diagnosed with diabetes mellitus, and/or medical history of gestational diabetes (GDM), impaired fasting glucose(IFG) and impaired glucose tolerance (IGT)
- BMI of 18.5 - 25.0 kg/m2
- Agree to maintain constant physical activity levels for the duration of the study
- Agree to utilize contraception for the duration of the study (for female subjects)
- Have a minimum of 12 natural teeth
- Scoring of 2 or more on dental screening questionnaire (See appendix)
- Ability to communicate in English
Exclusion
- Acute weight loss/weight gain over the past 6 months (defined as +4 lbs or more/month)
- History of diabetes
- Current Smokers (including those who quit \< 1 year)
- Heavy alcohol drinkers, defined as drinking more than 7 drinks/week. Those who drink alcohol will need to be reported and documented. They will be asked to maintain the levels of alcohol consumption throughout the study.
- Medical history of vascular diseases (CAD, MI, stroke, CABG, angioplasty), diabetes, liver disease, kidney disease, cancer, AIDS, bleeding disorders
- History of food allergies or to any food products in the diet menu.
- Enrolled in another investigational study within 1 month prior to screening for this study
- Vegetarian, those with significant food aversions, and anyone who cannot comply with the diet
- Pregnancy or breasting feeding
- Other autoimmune or inflammatory conditions or diseases that may compromise the patient's safety or compliance during the study on an individual basis
- Chronic use of antibiotics or anti-inflammatory medications (\>1 month) within the past year
- On medications such as statins, angiotensin converting enzyme inhibitor, warfarin, aspirin or other anti-inflammatory medications. Daily multivitamins are permitted, excluding pharmacological doses of anti- oxidants will not be allowed.
- Individuals with dental needs requiring extensive dental restorations such as cavities, root canals, crowns, etc.
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00379548
Start Date
November 1 2005
End Date
September 1 2014
Last Update
March 20 2017
Active Locations (1)
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1
Joslin Diabetes Center
Boston, Massachusetts, United States, 02215