Changes in Inflammatory State in Asian Americans Changing From Traditional Asian Diets to American Diet - a Pilot Study
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00379548 |
Recruitment Status :
Completed
First Posted : September 22, 2006
Last Update Posted : March 20, 2017
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 change from a traditional Asian diet to a typical Western diet. These inflammatory responses will be reflected by the activation of monocytes as measured by protein kinase C (PKC), a known activator of monocytes.
We also hypothesize that the changes of these inflammatory responses in the gingival crevicular fluid (GCF) will reflect similar changes of these markers in the plasma and monocytes.
Specific aims:
- To compare the inflammatory responses (primarily PKC activation in monocytes), between Far-East Asian Americans and Caucasian Americans, when they change from a traditional Asian diet to a typical American diet.
- To correlate the biochemical changes of inflammatory responses in the plasma and monocytes with those in the gingival crevicular fluid (GCF).
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Diabetes Insulin Resistance Inflammation Cardiovascular Disease Periodontal Disease | Behavioral: 2 groups of population responding to 2 types of diets | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 50 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Other |
Official Title: | A Pilot Study of the Changes in Inflammatory State in Asian Americans Changing From Traditional Asian Diet to Typical American Diets |
Study Start Date : | November 2005 |
Actual Primary Completion Date : | July 2008 |
Actual Study Completion Date : | September 2014 |

Arm | Intervention/treatment |
---|---|
No Intervention: 1
Control group- subjects are on the Asian diet for the entire duration of the study
|
|
Experimental: 2
Asian and Caucasian subjects switch from an Asian Diet to a Western Diet midway through the study.
|
Behavioral: 2 groups of population responding to 2 types of diets
Intervention groups include: Asian intervention and Caucasian intervention- both these groups switch from an Asian diet to a Western diet halfway through the study. |
- Changes in inflammatory markers including PKC and IL6 and Gingival Crevicular Fluid [ Time Frame: before Asian Diet, after 8 weeks of Asian Diet, after 8 weeks of Western Diet ]
- Lipid profiles [ Time Frame: before Asian Diet, after 8 weeks of Asian Diet, after 8 weeks of Western Diet ]
- Blood glucose levels [ Time Frame: before Asian Diet, after 8 weeks of Asian Diet, after 8 weeks of Western Diet ]
- Body Fat percentage assessed by Dual X-ray Absorption [ Time Frame: before Asian Diet, after 8 weeks of Asian Diet, after 8 weeks of Western Diet ]
- Insulin resistance assessed by HOMA [ Time Frame: before Asian Diet, after 8 weeks of Asian Diet, after 8 weeks of Western Diet ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 25 Years to 55 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 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 Criteria:
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00379548
United States, Massachusetts | |
Joslin Diabetes Center | |
Boston, Massachusetts, United States, 02215 |
Principal Investigator: | George L King, MD | Joslin Diabetes Center |
Responsible Party: | Joslin Diabetes Center |
ClinicalTrials.gov Identifier: | NCT00379548 |
Other Study ID Numbers: |
04-47 |
First Posted: | September 22, 2006 Key Record Dates |
Last Update Posted: | March 20, 2017 |
Last Verified: | March 2017 |
Periodontal Diseases Cardiovascular Diseases Insulin Resistance Inflammation Pathologic Processes |
Hyperinsulinism Glucose Metabolism Disorders Metabolic Diseases Mouth Diseases Stomatognathic Diseases |