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

September 21, 2006
March 25, 2014
November 2005
July 2008   (final data collection date for primary outcome measure)
  • 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 ]
  • Changes in inflammatory markers including PKC and IL6 and Gingival Crevicular Fluid
  • Lipid profiles
  • Blood glucose levels
  • Body Fat percentage assessed by Dual X-ray Absorption
  • Insulin resistance assessed by HOMA
Complete list of historical versions of study NCT00379548 on ClinicalTrials.gov Archive Site
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Changes in Inflammatory State in Asian Americans Changing From Traditional Asian Diets to American Diet - a Pilot Study
A Pilot Study of the Changes in Inflammatory State in Asian Americans Changing From Traditional Asian Diet to Typical American Diets

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).
Not Provided
Interventional
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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
  • Diabetes
  • Insulin Resistance
  • Inflammation
  • Cardiovascular Disease
  • Periodontal Disease
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.
  • 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.
    Intervention: Behavioral: 2 groups of population responding to 2 types of diets
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
50
December 2014
July 2008   (final data collection date for primary outcome measure)

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.
Both
25 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00379548
04-47
Yes
Joslin Diabetes Center
Joslin Diabetes Center
Sunstar, Inc.
Principal Investigator: George L King, MD Joslin Diabetes Center
Joslin Diabetes Center
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP