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Changes in Inflammatory State in Asian Americans Changing From Traditional Asian Diets to American Diet - a Pilot Study

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Sunstar, Inc.
Information provided by (Responsible Party):
Joslin Diabetes Center
ClinicalTrials.gov Identifier:
NCT00379548
First received: September 21, 2006
Last updated: March 25, 2014
Last verified: March 2014
History of Changes
  Purpose

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:

  1. 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.
  2. To correlate the biochemical changes of inflammatory responses in the plasma and monocytes with those in the gingival crevicular fluid (GCF).

Condition Intervention
Diabetes
Insulin Resistance
Inflammation
Cardiovascular Disease
Periodontal Disease
 Behavioral: 2 groups of population responding to 2 types of diets

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: A Pilot Study of the Changes in Inflammatory State in Asian Americans Changing From Traditional Asian Diet to Typical American Diets

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Joslin Diabetes Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Lipid profiles [ Time Frame: before Asian Diet, after 8 weeks of Asian Diet, after 8 weeks of Western Diet ] [ Designated as safety issue: No ]
  • Blood glucose levels [ Time Frame: before Asian Diet, after 8 weeks of Asian Diet, after 8 weeks of Western Diet ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Insulin resistance assessed by HOMA [ Time Frame: before Asian Diet, after 8 weeks of Asian Diet, after 8 weeks of Western Diet ] [ Designated as safety issue: No ]
Enrollment: 50
Study Start Date: November 2005
Estimated Study Completion Date: December 2014
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility
Ages Eligible for Study:   25 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Caucasian or Far-East Asian decent
  2. Ages between 25 - 55 years old
  3. 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)
  4. BMI of 18.5 - 25.0 kg/m2
  5. Agree to maintain constant physical activity levels for the duration of the study
  6. Agree to utilize contraception for the duration of the study (for female subjects)
  7. Have a minimum of 12 natural teeth
  8. Scoring of 2 or more on dental screening questionnaire (See appendix)
  9. Ability to communicate in English

Exclusion Criteria:

  1. Acute weight loss/weight gain over the past 6 months (defined as +4 lbs or more/month)
  2. History of diabetes
  3. Current Smokers (including those who quit < 1 year)
  4. 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.
  5. Medical history of vascular diseases (CAD, MI, stroke, CABG, angioplasty), diabetes, liver disease, kidney disease, cancer, AIDS, bleeding disorders
  6. History of food allergies or to any food products in the diet menu.
  7. Enrolled in another investigational study within 1 month prior to screening for this study
  8. Vegetarian, those with significant food aversions, and anyone who cannot comply with the diet
  9. Pregnancy or breasting feeding
  10. Other autoimmune or inflammatory conditions or diseases that may compromise the patient's safety or compliance during the study on an individual basis
  11. Chronic use of antibiotics or anti-inflammatory medications (>1 month) within the past year
  12. 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.
  13. Individuals with dental needs requiring extensive dental restorations such as cavities, root canals, crowns, etc.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00379548

Locations
United States, Massachusetts
Joslin Diabetes Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Joslin Diabetes Center
Sunstar, Inc.
Investigators
Principal Investigator: George L King, MD Joslin Diabetes Center
  More Information

Additional Information:
Asian American Diabetes Initiative  This link exits the ClinicalTrials.gov site

No publications provided by Joslin Diabetes Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Joslin Diabetes Center
ClinicalTrials.gov Identifier: NCT00379548     History of Changes
Other Study ID Numbers: 04-47
Study First Received: September 21, 2006
Last Updated: March 25, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Cardiovascular Diseases
Insulin Resistance
Periodontal Diseases
Glucose Metabolism Disorders
 Hyperinsulinism
Metabolic Diseases
Mouth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on February 27, 2015