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

Sponsor
Joslin Diabetes Center (Other)
Overall Status
Completed
CT.gov ID
NCT00379548
Collaborator
Sunstar, Inc. (Industry)
50
1
2
106
0.5

Study Details

Study Description

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 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 or Disease Intervention/Treatment Phase
  • Behavioral: 2 groups of population responding to 2 types of diets
N/A

Study Design

Study Type:
Interventional
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 :
Nov 1, 2005
Actual Primary Completion Date :
Jul 1, 2008
Actual Study Completion Date :
Sep 1, 2014

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Changes in inflammatory markers including PKC and IL6 and Gingival Crevicular Fluid [before Asian Diet, after 8 weeks of Asian Diet, after 8 weeks of Western Diet]

  2. Lipid profiles [before Asian Diet, after 8 weeks of Asian Diet, after 8 weeks of Western Diet]

  3. Blood glucose levels [before Asian Diet, after 8 weeks of Asian Diet, after 8 weeks of Western Diet]

  4. Body Fat percentage assessed by Dual X-ray Absorption [before Asian Diet, after 8 weeks of Asian Diet, after 8 weeks of Western Diet]

  5. Insulin resistance assessed by HOMA [before Asian Diet, after 8 weeks of Asian Diet, after 8 weeks of Western Diet]

Eligibility Criteria

Criteria

Ages Eligible for Study:
25 Years to 55 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Locations

Site City State Country Postal Code
1 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Joslin Diabetes Center
ClinicalTrials.gov Identifier:
NCT00379548
Other Study ID Numbers:
  • 04-47
First Posted:
Sep 22, 2006
Last Update Posted:
Mar 20, 2017
Last Verified:
Mar 1, 2017

Study Results

No Results Posted as of Mar 20, 2017